Analysis of the application of LiFePO4 batteries in base stations
lung cancer app (lucapp) study protocol: a randomised controlled trial to evaluate a mobile supportive care app for patients with metastatic lung cancer
by：CTECHi
2020-04-20
Mobile health technology may enhance patient empowerment and data integration throughout the care process.
However, these interventions pose relatively new regulatory, organizational and technical challenges, limiting appropriate assessments.
Lung cancer App (LuCApp)
Is a mobile app developed by researchers and clinicians to facilitate real-time
Time monitoring and management of patient symptoms.
The protocol presents a clinical trial designed to assess availability, effectiveness and cost
Effectiveness of LuCApp and nursing standards.
Method and analysis this is a 24-week two-arm non-
A multi-center parallel randomized controlled trial of blind method.
A total of 120 adult patients were diagnosed with small or non-
In addition to receiving standard care at three tumor sites in northern Italy, small cell lung cancer eligible for drug treatment will be assigned 1: 1 to receive standard care or LuCApp.
During treatment, LuCApp allows daily monitoring and grading of symptom lists that alert doctors if a predefined severity threshold is reached.
The patient will complete the baseline assessment and a group of effective and reliable patients
The reported results are measured every 3 ± 1 weeks, up to 24 weeks.
The main result is the change in the index score of test results in the assessment of cancer treatment function (Lung)
Questionnaires from baseline to 12 weeks.
Secondary outcome is lung cancer subscale, European quality of life 5D-
5L questionnaire, Hospital Anxiety and Depression Scale, Summary of supportive care needs survey, application availability questionnaire and Zarit burden interview with primary caregivers.
The trial received ethical approval from three clinical sites.
Test results will be disseminated through peers
Review of publications and conference reports.
Conclusion This trial is timely helpful in testing mobile apps designed to improve quality of life and quality of care for lung cancer patients.
Trial registration of NumberNCT03512015; Pre-results.
Introducing mobile health technology can empower patients and integrate data throughout the care process.
However, these interventions pose relatively new regulatory, organizational and technical challenges, limiting appropriate assessments.
Lung cancer App (LuCApp)
Is a mobile app developed by researchers and clinicians to facilitate real-time
Time monitoring and management of patient symptoms.
The protocol presents a clinical trial designed to assess availability, effectiveness and cost
Effectiveness of LuCApp and nursing standards.
Method and analysis this is a 24-week two-arm non-
A multi-center parallel randomized controlled trial of blind method.
A total of 120 adult patients were diagnosed with small or non-
In addition to receiving standard care at three tumor sites in northern Italy, small cell lung cancer eligible for drug treatment will be assigned 1: 1 to receive standard care or LuCApp.
During treatment, LuCApp allows daily monitoring and grading of symptom lists that alert doctors if a predefined severity threshold is reached.
The patient will complete the baseline assessment and a group of effective and reliable patients
The reported results are measured every 3 ± 1 weeks, up to 24 weeks.
The main result is the change in the index score of test results in the assessment of cancer treatment function (Lung)
Questionnaires from baseline to 12 weeks.
Secondary outcome is lung cancer subscale, European quality of life 5D-
5L questionnaire, Hospital Anxiety and Depression Scale, Summary of supportive care needs survey, application availability questionnaire and Zarit burden interview with primary caregivers.
The trial received ethical approval from three clinical sites.
Test results will be disseminated through peers
Review of publications and conference reports.
Conclusion This trial is timely helpful in testing mobile apps designed to improve quality of life and quality of care for lung cancer patients.
Trial registration of NumberNCT03512015; Pre-results.
Introducing significant advances in the diagnosis and treatment of cancer means that it can be managed like other chronic diseases
Active monitoring of terms is required.
In order to improve the quality of life of patients, the traditional parental model
The provider relationship is often unilateral and the patient has little say in his/her approach to care and may need to be overtaken by a new model of care.
For this purpose, self
Management interventions can help patients and their families take care of themselves in the course of cancer care continuity. Self-
Management here is defined as \"the ability of individuals to manage the inherent symptoms of chronic diseases, treatment, physical and psychological social consequences, and lifestyle changes \".
In terms of cancer care, patient involvement is also aimed at strengthening symptom management.
Although the latest advances in cancer treatment lead to better clinical outcomes, 3 treatments
The associated side effects may be significant and may therefore have an impact on treatment compliance, frequency of hospital stay and associated costs, as well as the health of patients and their caregivers --
Quality of Life (HRQoL).
The need for self
The unsustainability of management systems and current medical spending has witnessed rapid and sustained growth in mobile technology, including mobile health (mHealth)
Defined as \"medical and public health practices supported by mobile devices such as mobile phones, patient monitoring devices, personal digital assistants, and other wireless devices \".
4 as a thriving technology, mHealth can help empower patients and patient centers throughout the care process to support clinical decision-making
Strengthen the data generation process by integrating data from several different sources and by connecting stakeholders in the healthcare pathway.
However, mHealth products also present relatively new regulatory, organizational and technical challenges that need to be addressed in order to ensure proper evaluation and use.
5 6 although there are more than 325000 mHealth apps (apps)
There are both major app stores and more than 3 app stores.
The number of downloads in 2017 was 6 billion, with a growth rate of more than 12.
An increase of 5% over the previous year, 7 overall scientific evidence on the effectiveness of mHealth applications in improving health
There are very few results.
Few mHealth apps for self
Management of cancer patients has been proposed and evaluated.
Basch and others tested the symptom self.
During routine cancer treatment, through symptom tracking and reporting for routine care, 8 showed that HRQoL in the intervention group decreased less than routine care, with a significant impact on overall survival in posthoc analysis (adjusted HR 0. 83, 95%u2009CI 0. 70 to 0. 99).
Dennis and others have compared. follow-
Standard monitoring was used to detect recurrence of lung cancer, and the overall survival rate of the experiment was improved compared with the control group (HR 0. 32, 95%u2009CI 0. 15 to 0. 67).
On 2016, the University of Surrey launched electronic symptom management using the advanced symptom management system (ASyMS)
Research on remote technology, a 5-
Randomized controlled trials of the year (RCT)
Conducted in five European countries to test the impact of customs administration on patients
First-line chemotherapy for breast, colorectal or blood tumors.
10 in Italy, several oncologists of \"fondazione IRCCS\" spoke to dei ionale tumori (Milan)
Together with researchers and software developers, a web-based self-
A management system tailored for cancer patients.
An extended clinical research team at the University of Bocconi and AdvicePharma has been gradually adjusted to improve the application in order to target lung cancer patients exclusively.
Lung cancer is the most common malignant tumor in the world, with a total of 1 cause of cancer death worldwide.
71 deaths in 2016.
11 the medical burden and cost caused by lung cancer is huge, its 5-
Annual survival rate (17. 8%)
Still much lower than other major cancers.
12. due to the significant impact of lung cancer symptoms on HRQoL and the severity of side effects associated with existing drug treatments for this condition, we believe this group is suitable for testing self-health applications
Reporting and Management of symptoms and treatment
Related side effects
Lung cancer App (LuCApp)
First available on the Playstore (
Android online store)and on iTunes (
Apple Online Store)in April 2018.
They can, too.
Tested with some oncologists, healthcare professionals and palliative care experts from other professional cancer centers as cell phones
Allows real-time monitoring based on remote monitoring system
Patient symptoms and time collection of patients
Outcome measures of the report (PROMs)
Share with healthcare professionals during drug treatment for lung cancer.
Objective the main purpose of this study is to determine whether LuCApp is by improving itself
Treatment Monitoring-
Compared to current standards of care, induced side effects can lead to increased HRQoL scores measured by functional evaluation of cancer treatmentLung (FACT-L)
Questionnaire Survey from the beginning of drug treatment for lung cancer to 12 weeks (
Main endpoint)
The next 24 weeksup.
Other secondary objectives of this study will be to evaluate the impact of LuCApp during drug therapy for lung cancer and 12 and 24 weeks of follow-up
From the beginning of the treatment to the date of many results.
More specifically, the assumption about the impact that can be achieved through the application is: Measured by general preferences, improved HRQoL
Quality of life in Europe based on health measurement-5-Dimensions-5 Level (EQ-5D-5L).
Reduce anxiety and depression according to the Hospital Anxiety and Depression Scale (HADS),15 a self-
An evaluation scale used to detect the state of depression, anxiety, and emotional distress.
Positive impact on patient cancer support care needsà-
The survey of supportive care needs expresses their expectations (SCNS-SF34).
16 positive effects of health and mental health on caregiver burden
Survival, finance, social life and relationships with patients measured through Zarit Burden interviews (ZBI).
Acceptable cost
Based on the resource usage data collected throughout the research and quality, the effectiveness of LuCApp and standard care overviewadjusted life-years (QALY)
Calculated by EQ5D-
5L of the patient group.
Through the evaluation of the modified computer system usability questionnaire, LuCApp has good usability and user satisfaction (CSUQ)
Take the patient at the end of the study.
This is a 24-hour research design. week two-
Arm multi-center parallel randomized controlled trial to evaluate effectiveness and cost
LuCApp improves the effectiveness and availability of symptoms and HRQoL in lung cancer patients.
The protocol was developed in accordance with standard protocol item recommendation 18 for interventional trials and comprehensive standards for reporting electronic and mobile health application trials as well as an online remote health checklist.
Figure 19 shows the flow chart for recruitment and random.
Download figureOpen in new tabDownload powerpoint Figure 1 for screening, registration, random, data collection and analysis. EQ-
5 dimensions; FACT-
L. Functional evaluation of cancer treatment-Lung;
Hospital Anxiety and Depression Scale;
Intention of treatment;
LuCApp, lung cancer App; SCNS-
Table SF34 of the survey of supporting nursing needs;
ZBI, Zarit Burden interview
The subjects will be recruited from three Oncology sites in Italy: Fondazione IRCCS San Matteo (Pavia)
, Istituto Nazionale dei Tumori, Sao Paulo IRCCS (Milan)
Saga Hospital, St. Louis Guigon (Orbassano).
LuCApp research is led and sponsored by the University of boconey (Milan, Italy)
And registered in clinical trials. gov (NCT03512015).
The data management committee is not required because the trial is considered to be the least risky.
20 participants who screen and recruit qualified patients will be identified according to the inclusion and exclusion criteria in each site outpatient and/or inpatient oncology environment described in Table 1.
Once eligibility has been determined, the local clinical team will invite patients to join the study. During the pre-
During the registration phase, the patient will receive an invitation letter, a learning leaflet and an informed consent form.
Patients will have enough time to consider participation and be informed that they can discuss the study with any other person who is important before making a final decision.
If the patient agrees to participate, written informed consent will be obtained during the registered visit.
At this stage, patients will receive adequate training and detailed information from researchers (including research nurses, data managers, and oncologists) on the use of the application, who will also help patients download apps on their own devices.
All patients will be required to fill in before starting treatment-
In the baseline questionnaire on paper.
View this table: View the inline View pop-up table 1 eligibility criteria this is not a pure web-
Based on trial, becauseto-
There will still be facial contact: patients included in the intervention group will complete follow-up
Fill out the questionnaire through the application, while the patients in the comparison group (SoC)
Follow-up work will be completed
Collect paper questionnaires during the outpatient period or through telephone interviews with the research team.
Random once informed consent is received and baseline PROMs are collected, the researchers dedicated to recruitment will obtain random grouping codes from random mutation blocks layered by location and treatment (
Chemotherapy, immunotherapy and targeted therapy)
, Electronically generated and assigned to patients via a secure network
Electronic case report form.
The electronic data collection system used for research is verified, safe and redundant and meets the standard requirements of the Food and Drug Administration.
Standard operating procedures have been developed for the data management process.
This study is right
Blind because it is not possible to blind participants and personnel when such intervention and PROMs are under investigation.
However, the clinician version of luCApp does not allow physicians to monitor the HRQoL questionnaire completed by patients, who will receive information that is truly lacking in evidence related to the effectiveness of the application and will be blinded to the research hypothesis.
Participants will continue the study until 24-
Unless treatment is stopped early due to cessation of cancer treatment, voluntary withdrawal or death, weekly dry expectations.
With the help of the local team, intervention patients assigned to the intervention department will download the app on their phone and log in by inserting a newly generated custom email
Email address and selfSelect Password.
Patients assigned to this arm will be trained to use LuCApp as a tool for self
Reporting lung cancer symptoms and side effects of treatment and PROMs during the admission visit.
They will be assisted by the technical \"help desk\" throughout the study period.
In addition, the data manager will regularly check the data uploaded by the intervention group, and only for the purposes of this study, the research team will contact by email or telephone about every two weeks to verify that there are technical issues, apps are also encouraged to use.
LuCApp is currently in version 5 and we do not expect any updates during the study (figures 2–3).
Download the new tabDownload figureOpen powerpointFigure App for lung cancer in the month (LuCApp)
Patient version.
The patient has access to the home screen of the self
Monitoring, information and questionnaires;
Daily symptom questionnaire and healthy examples
The quality of life associated with the visual simulation scale.
Figure 3 application for lung cancer (LuCApp)
Doctor\'s edition
Examples of actions taken by the main screen and in response to the alarm.
During the study, the use of the application will be carried out through the patient\'s own mobile device and will depend on the usual network connection.
Every time a patient accesses an app, they need to log in: this will guarantee the collection of verified data and sensitive data is accessible to only the patient.
Android and iOS versions of the app (Patient Version)
As a data capture interface, collect data under https security protocol and transfer it to the database behind the electronic data capture platform.
Patients not compensated (by cash or in-kind)
For their participation in the trial, they will not be required to pay for the app, which will be downloaded for free.
The intervention offers several different and unique features and components designed to help the symptoms self-
Report and management: \"How do you feel today?
\"This part of the app allows participants to fill out a questionnaire to report on the day-to-day situation of side effects that they often have during lung cancer treatment and to determine from the literature.
21-24 from the initial list of 68 symptoms, 2 groups of lung cancer experts examined the symptoms they considered relevant to the group of patients surveyed and crossed
The respective selections were validated to get the final list of 22 items.
Symptoms will be scored according to the criteria from 0 to 4 (
Where 0 is a symptom that does not exist, and 4 is the maximum severity).
According to the National Cancer Institute\'s general terminology standard for adverse events, the problem was adapted for patient use (CTCAE).
Whenever a symptom of ≥ 3 is inserted, LuCApp will trigger an alarm to a healthcare professional.
Patients will be aware that reporting symptoms that exceed this threshold will alert clinicians: for real answers, for each symptom, we include a detailed description and a set of options, these options have specific criteria, refer to the exact level listed in CTCAE.
Although it is possible to compile several times a day, the patient will receive a reminder (
As a mobile banner or email)
Fill out this questionnaire every three days.
Up to three different reminders will be sent at 12: 00, 18: 00 and 21 to encourage the patient to self-
Report their symptoms using the recall period of the past 24 hours.
Symptom reports are for use only by clinicians.
\"Temperature\" and \"weight \"-
Patients with LuCApp arm will be required to enter the body temperature and weight again once a week via a mobile phone banner or email.
Patients will be advised to enter their daily body temperature at similar times per day and use the same scale to measure their weight.
Whenever the body temperature exceeds 38 °C or the body weight drops 5% for two consecutive weeks, a specific alert will be generated to inform the clinical team.
\"Tips for the day \"-
Every time a patient logs in to the app, a daily prompt is displayed, a short suggestion to better manage the side effects of treatment.
Tips are from clinical practice guidelines and discussed by consensus expert groups including medical oncologists, radiation oncologists, surgeons, nutritionists, language pathologists, infectious disease experts, dentists and nurses.
26 27 questionnaires
Patients are allowed to fill in this section-
In several projects on their HRQoL and experience in supportive care needs and LuCApp: EQ-5D-5L, FACT-L, HADS, SCNS-
Usability and satisfaction questionnaire. ‘Info’—
In order to improve the overall understanding of the patient\'s condition and management choices, this section organizes relevant educational materials, such as general information on lung cancer, treatment, patient rights, and useful institutional links.
The direct result is that, although including targeted therapy and chemotherapy may mean that some patients will receive oral treatment at home rather than oral treatment at a hospital or clinic, the purpose of the application is not to manage drug compliance, at least not directly manage drug compliance.
When data entry is scheduled, an automatic reminder will strongly advise and encourage continuity in the use of the application.
Through LuCApp, clinicians will receive alerts on their dedicated LuCApp equipment (
Smartphones, laptops
And will be required to respond within 24 hours and record the type of intervention performed (
For example, referral to emergency room/hospital, telephone consultation on symptom management, dose modification, start/change of supportive drug, expected visit).
In the healthcare professional application only, clinicians can look at the longitudinal trend of the patient\'s clinical parameters.
The side effects, temperature and weight are shown in the chart over the selected time frame.
Prior to the start of this study, health care professionals will be trained through specialized courses.
We will provide contact details for LuCApp developers and technicians for help.
However, if the technique does not work properly and the clinician believes that there is an urgent need for the patient to take action, the research team is informed that the intervention group also applies the standard of care.
During weekends or national holidays, clinicians may not be able to be reached or an alert cannot be answered in a timely manner.
In addition, in this case, it is recommended that patients use standard care methods (eg, out-of-
Emergency Department service doctor).
In this case, the standard of care includes procedures for participating in the monitoring and recording of treatment currently provided by the center
The symptoms associated with lung cancer patients are consistent with the guidelines developed by the Italian medical oncology association.
28 participating centers are either specialized hospitals for research (
St. Mateo Hospital (tumoli Hospital)
Or teaching hospital (
San Diego saga Hospital).
During regular clinical visits with oncologists, symptoms in control group patients will be discussed and registered.
Patients are usually allowed to contact their website for symptoms that occur between scheduled visits or are advised to go out for a visitof-hour doctor.
St. Mateo Hospital and St. Louis Gonzaga hospital all have emergency departments, but not at tumoli hospital.
PROMs will fill out the paper questionnaire in accordance with the same schedule as LuCApp patients during their outpatient period or through telephone interviews with the research team.
As part of this randomized controlled trial, LuCApp will be evaluated based on the impact on :(1)HRQoL, (2)
Need for cancer support treatment ,(3)
The burden of caregivers ,(4)resource use, (5)
Availability and patient satisfaction.
The reasons for choosing these measures and their features are described in detail below. Health-
Selection of relevant quality of life HRQoL measurements based on the availability of an effective Italian version of the tool for self-evaluation
Reported use, can be managed via paper and smartphone, usually for lung cancer patients.
The symptom is the subjective experience of the self
Reported by patients, is a subset of patients\' perceptions of health status and HRQoL.
29 HRQoL is a multi-dimensional structure composed of multiple functional scales (
Such as: physical function, psychological function, social role function)
Symptom Scale (eg, disease-
Related or treatment
Related symptoms).
Three questionnaires were selected. FACT-
The questionnaire is a disease.
Capture specific measures for multi-dimensional quality of life of lung cancer patients.
Symptoms include shortness of breath, weight loss, awareness, cough, hair loss, appetite, chest tightness, breathing. FACT-
L is the result of a combination of facts-G (
General modules and core instruments)
This is a general quality of life questionnaire for various chronic diseases with lung cancer subscale (LCS).
The evidence suggests that while people react slightly differently based on management patterns (ie, in-
Person or phone number of clinic or managed by mail/computer)
These alternative formats are basically equivalent, especially when data is reported at the group level.
30 questionnaires will be conducted at the end of the baseline, 12 weeks and study period. EQ-5D-
5L is a general preference
Based on the measurement of health status, this is the most commonly used tool for exporting utility values that can be used in the economic assessment model.
This tool is also frequently used in lung cancer trials.
31 including 5-
Level issues covering five areas: mobility, self
Nursing, daily activities, pain and discomfort, anxiety and depression.
In addition, patients were asked to fill in their feelings today on the vertical visual analog scale.
The questionnaire will be conducted at baseline, every 3 ± 1 week, to take into account the possible differences between the patient and the different therapies and at the end of the study. HADS is a self-
The developed assessment scale was designed to detect depression, anxiety and mood distress status of patients treated for various problems in outpatient settings.
It consists of two 7-
Item Scale for Depression and anxiety.
HADS is considered one of the most commonly used courses in advanced courses
Staging clinical trials of drugs for lung cancer, 32, have been used to measure HRQoL in non-lung cancer patients
Small cell lung cancer.
33 The literature suggests that HADS is a reliable and effective tool for identifying patients with mood disorders.
34 The questionnaire will be conducted at the end of the baseline, 12 weeks and study period.
Cancer support care needs in patients with lung cancer have greater unmet support care needs than in other cancer patients.
35 summary of survey of supportive nursing needs (SCNS-SF34)
Is a demand assessment questionnaire in cancer support care that measures the gap between patient experience and expectations.
36 37 it consists of 31 projects covering 4 areas: psychological needs, health systems and information needs, physical and daily life needs, and patient care and support needs.
For each problem, the patient is required at 5-
Point Special scale.
There is still no evidence that SCNC-
SF34 changes over time;
However, this is being tested in the longitudinal study currently in progress. 37 The SCNS-
SF34 is available for the intervention group on LuCApp and will be managed at the end of the study to assess whether the different research departments have met the supportive care needs.
ZBI is a 22-item self-
Management scale for measuring the burden of health and mental health care personnel
Life, finance, social life and relationships with patients.
Each project in 5-
Point Special scale.
Get the total burden by adding scores to all 22 items: the higher the score, the higher the burden.
ZBI is widely cited in studies that measure the burden of care for cancer patients.
38 39 the evaluation time of ZBI will be managed in paper form or by telephone at the end of the study.
Availability and satisfaction of LuCAppPatients in the intervention group will have the opportunity to provide feedback on the advantages and disadvantages of the application, including unexpected/unexpected effects.
The use and adoption of metrics is an important outcome of the process of understanding the mechanism of action of this intervention.
The MHealth app contains a tracking system.
The frequency and duration of logins and activities will be recorded and evaluated.
To test the user\'s satisfaction with the app, a modified CSUQ will be made to patients and clinicians using LuCApp.
CSUQ is an overall satisfaction questionnaire developed with other subjective usability measures from post-90 s IBM.
40 CSUQ was later adapted for mobile app usability testing to elicit participants\' satisfaction with pediatric risk assessment applications, an mHealth tool designed to help healthcare professionals
Limited settings will detect high-risk patients
Hospital and post-discharge mortality
41 The final version consists of 12 items assessed by the Likert scale.
In addition, three qualitative questions were added to obtain more information on the application and general capabilities of LuCApp in current and other clinical settings :(1)
\"What do you like best about this app? ”; (2)
\"What do you dislike the most about this app? \"; (3)
\"How can I change the app to make it easier to use? \".
The questionnaire will be conducted at the end of the study.
The use of resource user resources will be obtained through patient symptom reports for these symptoms and actions of clinicians (
For example, prescriptions, inpatient treatment including emergency access, changes in treatment).
In addition, additional information will be obtained for control group and treatment group patients by means of instruments and diagnostic tests conducted at the clinic, general practitioners or specialist visits, additional medications taken or forms administered during dietary supplements, hospital or emergency occurred between the two visits. Average per-
Patient clinician time spent on LuCApp management, including trouble shooting or reminding contacts established with patients, or, at different time points in the study, standard Nursing Management of lung cancer treatment symptoms will be derived by issuing questionnaires to clinicians. Study close-
Outdoor Research Center-
Patients in the intervention group will not continue to use the app for 24 weeks and will revert to the standard of care.
They will fill out all PROMs through the app, while for standard care patients, PROMs will be collected in the hospital during the temporary closure.
As for ZBI, the primary caregiver will be responsible at the end of the study and it will be done in person or by phone.
Changes in the index of sample size calculation test results (TOI)of the FACT-
The primary end point of the study was the questionnaire from baseline to 12 weeks. FACT-
L The questionnaire contains four general symptoms and one lung cancer symptom
Specific component table
The general component table includes: Physical wellBeing (PWB)
Social/family benefits
Emotional Health-
Good function-Being (FWB).
42 LCS to assess symptoms commonly reported in patients with lung cancer (
Short breath; short breathloss of weight;
Chest tightness).
TOI is derived by adding the scores on the PWB and FWB subscales to the LCS.
Because they contain the most relevant questions about symptoms and physical functioning, LCS and TOI were selected as the main focus of this analysis. All FACT-
L problem in 5-point Likert-
Model scales in the range of 0 (‘not at all’)to 4 (‘very much’).
The TOI scores range from 0 to 84, with higher scores representing better HRQoL or fewer symptoms.
After considering the turnover rate of about 20%, we estimate that 120 patients were assigned 1: 1 between the LuCApp and the routine care group, and this study will have a strength of 90%. sided α of 0.
05 detected-
Given the set SD of 15, the change of TOI score from baseline to 12 weeks had a group difference of 5 points 43.
44 baseline demographic and clinical features of the plan will be analyzed by the treatment group and descriptive statistics will be provided.
For the primary HRQoL endpoint that changed from baseline, in fact-
12 weeks after random grouping, repeat-
A mixed model will be used for measurement analysis to test the differences between the LuCApp and standard care groups, and adjustments will be made based on baseline values and features, medication, treatment site, and treatment length.
The proportion of patients who experienced a baseline score improvement, constant or deterioration in each arm will be compared using either the X2 or Fisher precision test.
This analysis will be conducted for any changes in the special subscale and clinically meaningful changes.
43 for all other questionnaires, baseline changes or follow-up
Only 12 weeks and 24 weeks after randomized grouping, the up values will be calculated and compared in the LuCApp group and in the control group.
Repeated measurements of the results will be analyzed again, and mixed model adjustments will be made to the relevant covariates, like the primary end point, for up to 24 weeks.
The analysis of the missing data will first determine how common the problem is and whether it can be assumed that it is randomly missing or randomly missing.
Multiple sensitivity filling analysis will be performed, including the observed value of the last carry-over, the minimum observed value of the carry-over, the average observed value of the carry-over, and multiple fills. EQ-
If the death occurs 6 months ago, the 5D value will be set to zero.
The survival time will be calculated from the date of admission to the date of death, or the person alive will be reviewed at the last follow-up --
Kaplan was used-Meier method.
The Cox proportional risk model will be fitted to evaluate the impact of LuCApp on survival and adjust the Population features and baseline performance status.
Preliminary analysis will be based on the following intentto-Treat principles. Secondary per-
The use and adoption metrics provided through the application embedded tracking system will be considered to perform protocol analysis. By combining emotional intelligence5D-
Derivative utility and survival QALY of both arms participants will be calculated and compared using two sets of t-
Test between LuCApp and standard care arm.
The multivariate linear regression model with QALY as the dependent variable will be used to adjust other covariates.
Resource consumption and associated costs will be calculated and reported for each treatment group and compared by parameters and non-parameters
Parameter test.
45 The perspective of assessing resource consumption will be the perspective of the national health care system.
The flat fee is EUR 2018.
The uniform cost of drugs will be derived from the national price list, visits, laboratory and instrument testing, and will be valued based on the outpatient procedure formula, although based on the existing tariff and special funding mechanisms in the Lombardy region, hospital stay and emergency access will be valued. Two-
Edge p value of
However, these interventions pose relatively new regulatory, organizational and technical challenges, limiting appropriate assessments.
Lung cancer App (LuCApp)
Is a mobile app developed by researchers and clinicians to facilitate real-time
Time monitoring and management of patient symptoms.
The protocol presents a clinical trial designed to assess availability, effectiveness and cost
Effectiveness of LuCApp and nursing standards.
Method and analysis this is a 24-week two-arm non-
A multi-center parallel randomized controlled trial of blind method.
A total of 120 adult patients were diagnosed with small or non-
In addition to receiving standard care at three tumor sites in northern Italy, small cell lung cancer eligible for drug treatment will be assigned 1: 1 to receive standard care or LuCApp.
During treatment, LuCApp allows daily monitoring and grading of symptom lists that alert doctors if a predefined severity threshold is reached.
The patient will complete the baseline assessment and a group of effective and reliable patients
The reported results are measured every 3 ± 1 weeks, up to 24 weeks.
The main result is the change in the index score of test results in the assessment of cancer treatment function (Lung)
Questionnaires from baseline to 12 weeks.
Secondary outcome is lung cancer subscale, European quality of life 5D-
5L questionnaire, Hospital Anxiety and Depression Scale, Summary of supportive care needs survey, application availability questionnaire and Zarit burden interview with primary caregivers.
The trial received ethical approval from three clinical sites.
Test results will be disseminated through peers
Review of publications and conference reports.
Conclusion This trial is timely helpful in testing mobile apps designed to improve quality of life and quality of care for lung cancer patients.
Trial registration of NumberNCT03512015; Pre-results.
Introducing mobile health technology can empower patients and integrate data throughout the care process.
However, these interventions pose relatively new regulatory, organizational and technical challenges, limiting appropriate assessments.
Lung cancer App (LuCApp)
Is a mobile app developed by researchers and clinicians to facilitate real-time
Time monitoring and management of patient symptoms.
The protocol presents a clinical trial designed to assess availability, effectiveness and cost
Effectiveness of LuCApp and nursing standards.
Method and analysis this is a 24-week two-arm non-
A multi-center parallel randomized controlled trial of blind method.
A total of 120 adult patients were diagnosed with small or non-
In addition to receiving standard care at three tumor sites in northern Italy, small cell lung cancer eligible for drug treatment will be assigned 1: 1 to receive standard care or LuCApp.
During treatment, LuCApp allows daily monitoring and grading of symptom lists that alert doctors if a predefined severity threshold is reached.
The patient will complete the baseline assessment and a group of effective and reliable patients
The reported results are measured every 3 ± 1 weeks, up to 24 weeks.
The main result is the change in the index score of test results in the assessment of cancer treatment function (Lung)
Questionnaires from baseline to 12 weeks.
Secondary outcome is lung cancer subscale, European quality of life 5D-
5L questionnaire, Hospital Anxiety and Depression Scale, Summary of supportive care needs survey, application availability questionnaire and Zarit burden interview with primary caregivers.
The trial received ethical approval from three clinical sites.
Test results will be disseminated through peers
Review of publications and conference reports.
Conclusion This trial is timely helpful in testing mobile apps designed to improve quality of life and quality of care for lung cancer patients.
Trial registration of NumberNCT03512015; Pre-results.
Introducing significant advances in the diagnosis and treatment of cancer means that it can be managed like other chronic diseases
Active monitoring of terms is required.
In order to improve the quality of life of patients, the traditional parental model
The provider relationship is often unilateral and the patient has little say in his/her approach to care and may need to be overtaken by a new model of care.
For this purpose, self
Management interventions can help patients and their families take care of themselves in the course of cancer care continuity. Self-
Management here is defined as \"the ability of individuals to manage the inherent symptoms of chronic diseases, treatment, physical and psychological social consequences, and lifestyle changes \".
In terms of cancer care, patient involvement is also aimed at strengthening symptom management.
Although the latest advances in cancer treatment lead to better clinical outcomes, 3 treatments
The associated side effects may be significant and may therefore have an impact on treatment compliance, frequency of hospital stay and associated costs, as well as the health of patients and their caregivers --
Quality of Life (HRQoL).
The need for self
The unsustainability of management systems and current medical spending has witnessed rapid and sustained growth in mobile technology, including mobile health (mHealth)
Defined as \"medical and public health practices supported by mobile devices such as mobile phones, patient monitoring devices, personal digital assistants, and other wireless devices \".
4 as a thriving technology, mHealth can help empower patients and patient centers throughout the care process to support clinical decision-making
Strengthen the data generation process by integrating data from several different sources and by connecting stakeholders in the healthcare pathway.
However, mHealth products also present relatively new regulatory, organizational and technical challenges that need to be addressed in order to ensure proper evaluation and use.
5 6 although there are more than 325000 mHealth apps (apps)
There are both major app stores and more than 3 app stores.
The number of downloads in 2017 was 6 billion, with a growth rate of more than 12.
An increase of 5% over the previous year, 7 overall scientific evidence on the effectiveness of mHealth applications in improving health
There are very few results.
Few mHealth apps for self
Management of cancer patients has been proposed and evaluated.
Basch and others tested the symptom self.
During routine cancer treatment, through symptom tracking and reporting for routine care, 8 showed that HRQoL in the intervention group decreased less than routine care, with a significant impact on overall survival in posthoc analysis (adjusted HR 0. 83, 95%u2009CI 0. 70 to 0. 99).
Dennis and others have compared. follow-
Standard monitoring was used to detect recurrence of lung cancer, and the overall survival rate of the experiment was improved compared with the control group (HR 0. 32, 95%u2009CI 0. 15 to 0. 67).
On 2016, the University of Surrey launched electronic symptom management using the advanced symptom management system (ASyMS)
Research on remote technology, a 5-
Randomized controlled trials of the year (RCT)
Conducted in five European countries to test the impact of customs administration on patients
First-line chemotherapy for breast, colorectal or blood tumors.
10 in Italy, several oncologists of \"fondazione IRCCS\" spoke to dei ionale tumori (Milan)
Together with researchers and software developers, a web-based self-
A management system tailored for cancer patients.
An extended clinical research team at the University of Bocconi and AdvicePharma has been gradually adjusted to improve the application in order to target lung cancer patients exclusively.
Lung cancer is the most common malignant tumor in the world, with a total of 1 cause of cancer death worldwide.
71 deaths in 2016.
11 the medical burden and cost caused by lung cancer is huge, its 5-
Annual survival rate (17. 8%)
Still much lower than other major cancers.
12. due to the significant impact of lung cancer symptoms on HRQoL and the severity of side effects associated with existing drug treatments for this condition, we believe this group is suitable for testing self-health applications
Reporting and Management of symptoms and treatment
Related side effects
Lung cancer App (LuCApp)
First available on the Playstore (
Android online store)and on iTunes (
Apple Online Store)in April 2018.
They can, too.
Tested with some oncologists, healthcare professionals and palliative care experts from other professional cancer centers as cell phones
Allows real-time monitoring based on remote monitoring system
Patient symptoms and time collection of patients
Outcome measures of the report (PROMs)
Share with healthcare professionals during drug treatment for lung cancer.
Objective the main purpose of this study is to determine whether LuCApp is by improving itself
Treatment Monitoring-
Compared to current standards of care, induced side effects can lead to increased HRQoL scores measured by functional evaluation of cancer treatmentLung (FACT-L)
Questionnaire Survey from the beginning of drug treatment for lung cancer to 12 weeks (
Main endpoint)
The next 24 weeksup.
Other secondary objectives of this study will be to evaluate the impact of LuCApp during drug therapy for lung cancer and 12 and 24 weeks of follow-up
From the beginning of the treatment to the date of many results.
More specifically, the assumption about the impact that can be achieved through the application is: Measured by general preferences, improved HRQoL
Quality of life in Europe based on health measurement-5-Dimensions-5 Level (EQ-5D-5L).
Reduce anxiety and depression according to the Hospital Anxiety and Depression Scale (HADS),15 a self-
An evaluation scale used to detect the state of depression, anxiety, and emotional distress.
Positive impact on patient cancer support care needsà-
The survey of supportive care needs expresses their expectations (SCNS-SF34).
16 positive effects of health and mental health on caregiver burden
Survival, finance, social life and relationships with patients measured through Zarit Burden interviews (ZBI).
Acceptable cost
Based on the resource usage data collected throughout the research and quality, the effectiveness of LuCApp and standard care overviewadjusted life-years (QALY)
Calculated by EQ5D-
5L of the patient group.
Through the evaluation of the modified computer system usability questionnaire, LuCApp has good usability and user satisfaction (CSUQ)
Take the patient at the end of the study.
This is a 24-hour research design. week two-
Arm multi-center parallel randomized controlled trial to evaluate effectiveness and cost
LuCApp improves the effectiveness and availability of symptoms and HRQoL in lung cancer patients.
The protocol was developed in accordance with standard protocol item recommendation 18 for interventional trials and comprehensive standards for reporting electronic and mobile health application trials as well as an online remote health checklist.
Figure 19 shows the flow chart for recruitment and random.
Download figureOpen in new tabDownload powerpoint Figure 1 for screening, registration, random, data collection and analysis. EQ-
5 dimensions; FACT-
L. Functional evaluation of cancer treatment-Lung;
Hospital Anxiety and Depression Scale;
Intention of treatment;
LuCApp, lung cancer App; SCNS-
Table SF34 of the survey of supporting nursing needs;
ZBI, Zarit Burden interview
The subjects will be recruited from three Oncology sites in Italy: Fondazione IRCCS San Matteo (Pavia)
, Istituto Nazionale dei Tumori, Sao Paulo IRCCS (Milan)
Saga Hospital, St. Louis Guigon (Orbassano).
LuCApp research is led and sponsored by the University of boconey (Milan, Italy)
And registered in clinical trials. gov (NCT03512015).
The data management committee is not required because the trial is considered to be the least risky.
20 participants who screen and recruit qualified patients will be identified according to the inclusion and exclusion criteria in each site outpatient and/or inpatient oncology environment described in Table 1.
Once eligibility has been determined, the local clinical team will invite patients to join the study. During the pre-
During the registration phase, the patient will receive an invitation letter, a learning leaflet and an informed consent form.
Patients will have enough time to consider participation and be informed that they can discuss the study with any other person who is important before making a final decision.
If the patient agrees to participate, written informed consent will be obtained during the registered visit.
At this stage, patients will receive adequate training and detailed information from researchers (including research nurses, data managers, and oncologists) on the use of the application, who will also help patients download apps on their own devices.
All patients will be required to fill in before starting treatment-
In the baseline questionnaire on paper.
View this table: View the inline View pop-up table 1 eligibility criteria this is not a pure web-
Based on trial, becauseto-
There will still be facial contact: patients included in the intervention group will complete follow-up
Fill out the questionnaire through the application, while the patients in the comparison group (SoC)
Follow-up work will be completed
Collect paper questionnaires during the outpatient period or through telephone interviews with the research team.
Random once informed consent is received and baseline PROMs are collected, the researchers dedicated to recruitment will obtain random grouping codes from random mutation blocks layered by location and treatment (
Chemotherapy, immunotherapy and targeted therapy)
, Electronically generated and assigned to patients via a secure network
Electronic case report form.
The electronic data collection system used for research is verified, safe and redundant and meets the standard requirements of the Food and Drug Administration.
Standard operating procedures have been developed for the data management process.
This study is right
Blind because it is not possible to blind participants and personnel when such intervention and PROMs are under investigation.
However, the clinician version of luCApp does not allow physicians to monitor the HRQoL questionnaire completed by patients, who will receive information that is truly lacking in evidence related to the effectiveness of the application and will be blinded to the research hypothesis.
Participants will continue the study until 24-
Unless treatment is stopped early due to cessation of cancer treatment, voluntary withdrawal or death, weekly dry expectations.
With the help of the local team, intervention patients assigned to the intervention department will download the app on their phone and log in by inserting a newly generated custom email
Email address and selfSelect Password.
Patients assigned to this arm will be trained to use LuCApp as a tool for self
Reporting lung cancer symptoms and side effects of treatment and PROMs during the admission visit.
They will be assisted by the technical \"help desk\" throughout the study period.
In addition, the data manager will regularly check the data uploaded by the intervention group, and only for the purposes of this study, the research team will contact by email or telephone about every two weeks to verify that there are technical issues, apps are also encouraged to use.
LuCApp is currently in version 5 and we do not expect any updates during the study (figures 2–3).
Download the new tabDownload figureOpen powerpointFigure App for lung cancer in the month (LuCApp)
Patient version.
The patient has access to the home screen of the self
Monitoring, information and questionnaires;
Daily symptom questionnaire and healthy examples
The quality of life associated with the visual simulation scale.
Figure 3 application for lung cancer (LuCApp)
Doctor\'s edition
Examples of actions taken by the main screen and in response to the alarm.
During the study, the use of the application will be carried out through the patient\'s own mobile device and will depend on the usual network connection.
Every time a patient accesses an app, they need to log in: this will guarantee the collection of verified data and sensitive data is accessible to only the patient.
Android and iOS versions of the app (Patient Version)
As a data capture interface, collect data under https security protocol and transfer it to the database behind the electronic data capture platform.
Patients not compensated (by cash or in-kind)
For their participation in the trial, they will not be required to pay for the app, which will be downloaded for free.
The intervention offers several different and unique features and components designed to help the symptoms self-
Report and management: \"How do you feel today?
\"This part of the app allows participants to fill out a questionnaire to report on the day-to-day situation of side effects that they often have during lung cancer treatment and to determine from the literature.
21-24 from the initial list of 68 symptoms, 2 groups of lung cancer experts examined the symptoms they considered relevant to the group of patients surveyed and crossed
The respective selections were validated to get the final list of 22 items.
Symptoms will be scored according to the criteria from 0 to 4 (
Where 0 is a symptom that does not exist, and 4 is the maximum severity).
According to the National Cancer Institute\'s general terminology standard for adverse events, the problem was adapted for patient use (CTCAE).
Whenever a symptom of ≥ 3 is inserted, LuCApp will trigger an alarm to a healthcare professional.
Patients will be aware that reporting symptoms that exceed this threshold will alert clinicians: for real answers, for each symptom, we include a detailed description and a set of options, these options have specific criteria, refer to the exact level listed in CTCAE.
Although it is possible to compile several times a day, the patient will receive a reminder (
As a mobile banner or email)
Fill out this questionnaire every three days.
Up to three different reminders will be sent at 12: 00, 18: 00 and 21 to encourage the patient to self-
Report their symptoms using the recall period of the past 24 hours.
Symptom reports are for use only by clinicians.
\"Temperature\" and \"weight \"-
Patients with LuCApp arm will be required to enter the body temperature and weight again once a week via a mobile phone banner or email.
Patients will be advised to enter their daily body temperature at similar times per day and use the same scale to measure their weight.
Whenever the body temperature exceeds 38 °C or the body weight drops 5% for two consecutive weeks, a specific alert will be generated to inform the clinical team.
\"Tips for the day \"-
Every time a patient logs in to the app, a daily prompt is displayed, a short suggestion to better manage the side effects of treatment.
Tips are from clinical practice guidelines and discussed by consensus expert groups including medical oncologists, radiation oncologists, surgeons, nutritionists, language pathologists, infectious disease experts, dentists and nurses.
26 27 questionnaires
Patients are allowed to fill in this section-
In several projects on their HRQoL and experience in supportive care needs and LuCApp: EQ-5D-5L, FACT-L, HADS, SCNS-
Usability and satisfaction questionnaire. ‘Info’—
In order to improve the overall understanding of the patient\'s condition and management choices, this section organizes relevant educational materials, such as general information on lung cancer, treatment, patient rights, and useful institutional links.
The direct result is that, although including targeted therapy and chemotherapy may mean that some patients will receive oral treatment at home rather than oral treatment at a hospital or clinic, the purpose of the application is not to manage drug compliance, at least not directly manage drug compliance.
When data entry is scheduled, an automatic reminder will strongly advise and encourage continuity in the use of the application.
Through LuCApp, clinicians will receive alerts on their dedicated LuCApp equipment (
Smartphones, laptops
And will be required to respond within 24 hours and record the type of intervention performed (
For example, referral to emergency room/hospital, telephone consultation on symptom management, dose modification, start/change of supportive drug, expected visit).
In the healthcare professional application only, clinicians can look at the longitudinal trend of the patient\'s clinical parameters.
The side effects, temperature and weight are shown in the chart over the selected time frame.
Prior to the start of this study, health care professionals will be trained through specialized courses.
We will provide contact details for LuCApp developers and technicians for help.
However, if the technique does not work properly and the clinician believes that there is an urgent need for the patient to take action, the research team is informed that the intervention group also applies the standard of care.
During weekends or national holidays, clinicians may not be able to be reached or an alert cannot be answered in a timely manner.
In addition, in this case, it is recommended that patients use standard care methods (eg, out-of-
Emergency Department service doctor).
In this case, the standard of care includes procedures for participating in the monitoring and recording of treatment currently provided by the center
The symptoms associated with lung cancer patients are consistent with the guidelines developed by the Italian medical oncology association.
28 participating centers are either specialized hospitals for research (
St. Mateo Hospital (tumoli Hospital)
Or teaching hospital (
San Diego saga Hospital).
During regular clinical visits with oncologists, symptoms in control group patients will be discussed and registered.
Patients are usually allowed to contact their website for symptoms that occur between scheduled visits or are advised to go out for a visitof-hour doctor.
St. Mateo Hospital and St. Louis Gonzaga hospital all have emergency departments, but not at tumoli hospital.
PROMs will fill out the paper questionnaire in accordance with the same schedule as LuCApp patients during their outpatient period or through telephone interviews with the research team.
As part of this randomized controlled trial, LuCApp will be evaluated based on the impact on :(1)HRQoL, (2)
Need for cancer support treatment ,(3)
The burden of caregivers ,(4)resource use, (5)
Availability and patient satisfaction.
The reasons for choosing these measures and their features are described in detail below. Health-
Selection of relevant quality of life HRQoL measurements based on the availability of an effective Italian version of the tool for self-evaluation
Reported use, can be managed via paper and smartphone, usually for lung cancer patients.
The symptom is the subjective experience of the self
Reported by patients, is a subset of patients\' perceptions of health status and HRQoL.
29 HRQoL is a multi-dimensional structure composed of multiple functional scales (
Such as: physical function, psychological function, social role function)
Symptom Scale (eg, disease-
Related or treatment
Related symptoms).
Three questionnaires were selected. FACT-
The questionnaire is a disease.
Capture specific measures for multi-dimensional quality of life of lung cancer patients.
Symptoms include shortness of breath, weight loss, awareness, cough, hair loss, appetite, chest tightness, breathing. FACT-
L is the result of a combination of facts-G (
General modules and core instruments)
This is a general quality of life questionnaire for various chronic diseases with lung cancer subscale (LCS).
The evidence suggests that while people react slightly differently based on management patterns (ie, in-
Person or phone number of clinic or managed by mail/computer)
These alternative formats are basically equivalent, especially when data is reported at the group level.
30 questionnaires will be conducted at the end of the baseline, 12 weeks and study period. EQ-5D-
5L is a general preference
Based on the measurement of health status, this is the most commonly used tool for exporting utility values that can be used in the economic assessment model.
This tool is also frequently used in lung cancer trials.
31 including 5-
Level issues covering five areas: mobility, self
Nursing, daily activities, pain and discomfort, anxiety and depression.
In addition, patients were asked to fill in their feelings today on the vertical visual analog scale.
The questionnaire will be conducted at baseline, every 3 ± 1 week, to take into account the possible differences between the patient and the different therapies and at the end of the study. HADS is a self-
The developed assessment scale was designed to detect depression, anxiety and mood distress status of patients treated for various problems in outpatient settings.
It consists of two 7-
Item Scale for Depression and anxiety.
HADS is considered one of the most commonly used courses in advanced courses
Staging clinical trials of drugs for lung cancer, 32, have been used to measure HRQoL in non-lung cancer patients
Small cell lung cancer.
33 The literature suggests that HADS is a reliable and effective tool for identifying patients with mood disorders.
34 The questionnaire will be conducted at the end of the baseline, 12 weeks and study period.
Cancer support care needs in patients with lung cancer have greater unmet support care needs than in other cancer patients.
35 summary of survey of supportive nursing needs (SCNS-SF34)
Is a demand assessment questionnaire in cancer support care that measures the gap between patient experience and expectations.
36 37 it consists of 31 projects covering 4 areas: psychological needs, health systems and information needs, physical and daily life needs, and patient care and support needs.
For each problem, the patient is required at 5-
Point Special scale.
There is still no evidence that SCNC-
SF34 changes over time;
However, this is being tested in the longitudinal study currently in progress. 37 The SCNS-
SF34 is available for the intervention group on LuCApp and will be managed at the end of the study to assess whether the different research departments have met the supportive care needs.
ZBI is a 22-item self-
Management scale for measuring the burden of health and mental health care personnel
Life, finance, social life and relationships with patients.
Each project in 5-
Point Special scale.
Get the total burden by adding scores to all 22 items: the higher the score, the higher the burden.
ZBI is widely cited in studies that measure the burden of care for cancer patients.
38 39 the evaluation time of ZBI will be managed in paper form or by telephone at the end of the study.
Availability and satisfaction of LuCAppPatients in the intervention group will have the opportunity to provide feedback on the advantages and disadvantages of the application, including unexpected/unexpected effects.
The use and adoption of metrics is an important outcome of the process of understanding the mechanism of action of this intervention.
The MHealth app contains a tracking system.
The frequency and duration of logins and activities will be recorded and evaluated.
To test the user\'s satisfaction with the app, a modified CSUQ will be made to patients and clinicians using LuCApp.
CSUQ is an overall satisfaction questionnaire developed with other subjective usability measures from post-90 s IBM.
40 CSUQ was later adapted for mobile app usability testing to elicit participants\' satisfaction with pediatric risk assessment applications, an mHealth tool designed to help healthcare professionals
Limited settings will detect high-risk patients
Hospital and post-discharge mortality
41 The final version consists of 12 items assessed by the Likert scale.
In addition, three qualitative questions were added to obtain more information on the application and general capabilities of LuCApp in current and other clinical settings :(1)
\"What do you like best about this app? ”; (2)
\"What do you dislike the most about this app? \"; (3)
\"How can I change the app to make it easier to use? \".
The questionnaire will be conducted at the end of the study.
The use of resource user resources will be obtained through patient symptom reports for these symptoms and actions of clinicians (
For example, prescriptions, inpatient treatment including emergency access, changes in treatment).
In addition, additional information will be obtained for control group and treatment group patients by means of instruments and diagnostic tests conducted at the clinic, general practitioners or specialist visits, additional medications taken or forms administered during dietary supplements, hospital or emergency occurred between the two visits. Average per-
Patient clinician time spent on LuCApp management, including trouble shooting or reminding contacts established with patients, or, at different time points in the study, standard Nursing Management of lung cancer treatment symptoms will be derived by issuing questionnaires to clinicians. Study close-
Outdoor Research Center-
Patients in the intervention group will not continue to use the app for 24 weeks and will revert to the standard of care.
They will fill out all PROMs through the app, while for standard care patients, PROMs will be collected in the hospital during the temporary closure.
As for ZBI, the primary caregiver will be responsible at the end of the study and it will be done in person or by phone.
Changes in the index of sample size calculation test results (TOI)of the FACT-
The primary end point of the study was the questionnaire from baseline to 12 weeks. FACT-
L The questionnaire contains four general symptoms and one lung cancer symptom
Specific component table
The general component table includes: Physical wellBeing (PWB)
Social/family benefits
Emotional Health-
Good function-Being (FWB).
42 LCS to assess symptoms commonly reported in patients with lung cancer (
Short breath; short breathloss of weight;
Chest tightness).
TOI is derived by adding the scores on the PWB and FWB subscales to the LCS.
Because they contain the most relevant questions about symptoms and physical functioning, LCS and TOI were selected as the main focus of this analysis. All FACT-
L problem in 5-point Likert-
Model scales in the range of 0 (‘not at all’)to 4 (‘very much’).
The TOI scores range from 0 to 84, with higher scores representing better HRQoL or fewer symptoms.
After considering the turnover rate of about 20%, we estimate that 120 patients were assigned 1: 1 between the LuCApp and the routine care group, and this study will have a strength of 90%. sided α of 0.
05 detected-
Given the set SD of 15, the change of TOI score from baseline to 12 weeks had a group difference of 5 points 43.
44 baseline demographic and clinical features of the plan will be analyzed by the treatment group and descriptive statistics will be provided.
For the primary HRQoL endpoint that changed from baseline, in fact-
12 weeks after random grouping, repeat-
A mixed model will be used for measurement analysis to test the differences between the LuCApp and standard care groups, and adjustments will be made based on baseline values and features, medication, treatment site, and treatment length.
The proportion of patients who experienced a baseline score improvement, constant or deterioration in each arm will be compared using either the X2 or Fisher precision test.
This analysis will be conducted for any changes in the special subscale and clinically meaningful changes.
43 for all other questionnaires, baseline changes or follow-up
Only 12 weeks and 24 weeks after randomized grouping, the up values will be calculated and compared in the LuCApp group and in the control group.
Repeated measurements of the results will be analyzed again, and mixed model adjustments will be made to the relevant covariates, like the primary end point, for up to 24 weeks.
The analysis of the missing data will first determine how common the problem is and whether it can be assumed that it is randomly missing or randomly missing.
Multiple sensitivity filling analysis will be performed, including the observed value of the last carry-over, the minimum observed value of the carry-over, the average observed value of the carry-over, and multiple fills. EQ-
If the death occurs 6 months ago, the 5D value will be set to zero.
The survival time will be calculated from the date of admission to the date of death, or the person alive will be reviewed at the last follow-up --
Kaplan was used-Meier method.
The Cox proportional risk model will be fitted to evaluate the impact of LuCApp on survival and adjust the Population features and baseline performance status.
Preliminary analysis will be based on the following intentto-Treat principles. Secondary per-
The use and adoption metrics provided through the application embedded tracking system will be considered to perform protocol analysis. By combining emotional intelligence5D-
Derivative utility and survival QALY of both arms participants will be calculated and compared using two sets of t-
Test between LuCApp and standard care arm.
The multivariate linear regression model with QALY as the dependent variable will be used to adjust other covariates.
Resource consumption and associated costs will be calculated and reported for each treatment group and compared by parameters and non-parameters
Parameter test.
45 The perspective of assessing resource consumption will be the perspective of the national health care system.
The flat fee is EUR 2018.
The uniform cost of drugs will be derived from the national price list, visits, laboratory and instrument testing, and will be valued based on the outpatient procedure formula, although based on the existing tariff and special funding mechanisms in the Lombardy region, hospital stay and emergency access will be valued. Two-
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