Supportive Care Mobile Application for Patients With NSCLC

Study Overview
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Brief Summary
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This research study is looking at the role of a supportive care mobile app in improving symptoms, coping skills, and quality of life in patients with non-small cell lung cancer.

Detailed Description
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This research study is a Feasibility Study, which is the first-time investigators are examining this supportive care mobile app intervention. The goal of this research study is to refine and examine the feasibility and benefits of a supportive care mobile app to improve symptoms, coping skills, and quality of life in patients with non-small cell lung cancer. Many people diagnosed with lung cancer experience challenging symptoms and increased stress. To help address these concerns, this study is exploring how a mobile application (app) intervention, designed specifically for people with lung cancer, can expand the availability of much needed supportive care services. The research study procedures include: A supportive care mobile app consisting of six intervention modules that focus on components of wellbeing, such as physical, social, functional, and emotional wellbeing Questionnaires asking about demographic information (e.g., gender, ethnicity, income) and participants' experience with cancer (e.g., quality of life, symptoms) Data collection from participants medical records After completing a baseline study questionnaire, participants will be randomized into two (2) study groups: Usual Care Group: Participants will receive standard oncology care and attend their regular clinic visits. Study staff will monitor participant use of supportive care services. Intervention Group: Participants will be provided with a study-issued tablet computer to access the mobile app and receive tutorial and instructions for how to use the app. Participants will be in this research study for 12-14 weeks. It is expected that about 120 people will take part in this research study. The sponsors of this study are the National Comprehensive Cancer Network (NCCN) and AstraZeneca Pharmaceuticals. NCCN is a non-profit alliance of leading cancer centers across the United States, and AstraZeneca Pharmaceuticals is a global bio-pharmaceutical company. These two sponsors are together providing funding and oversight for the conduct of this research study.

Official Title
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Randomized Trial of a Supportive Care Mobile Application to Improve Symptoms, Coping, and Quality of Life in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Conditions
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Non Small Cell Lung Cancer, Quality of Life, Coping Skills

Intervention / Treatment
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* Behavioral: Supportive Care Mobile Application
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Diagnosed with unresectable Stage III or IV NSCLC in the past twelve weeks and receiving care with palliative intent (per clinician documentation in the electronic health record) Eastern Cooperative Oncology Group Performance Status = 0-3 Plan to receive oncology care at one of the participating study sites Ability to read and respond to questions in English Exclusion Criteria: Significant uncontrolled psychiatric disorder (e.g., psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the ability to participate in study procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care Mobile Application<br>Complete study questionnaires at two time points: upon enrollment at baseline prior to randomization approximately 12 weeks after the baseline assessment time point. Participants will be provided with a study-issued tablet computer to access mobile app and receive a comprehensive tutorial and detailed instructions on how to use the app. Participants will have approximately 10 weeks to complete the intervention modules at self initiated pace. The app will provide prompts as reminders to complete the modules. Participants will receive standard oncology care. Study staff will monitor participant use of supportive care services, such as social work, psychology, psychiatry, and palliative care. | Behavioral: Supportive Care Mobile Application<br>* Tablet computer with application providing modules on skills for managing symptoms and coping.<br>Other: Usual Care<br>* Standard oncology care with monitoring of supportive care services usage<br>|
| Active Comparator: Usual Care<br>Complete study questionnaires at two time points: upon enrollment at baseline prior to randomization approximately 12 weeks after the baseline assessment time point. Participants will receive standard oncology care. Study staff will monitor participant use of supportive care services, such as social work, psychology, psychiatry, and palliative care. | Other: Usual Care<br>* Standard oncology care with monitoring of supportive care services usage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study feasibility based on rates of participant recruitment and completion of assigned study procedures | Study feasibility will be defined as ≥ 65% approach-to-enrollment rate of eligible participants and ≥70% completion rate of study procedures (at least four mobile app modules and assigned study questionnaires) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported acceptability and usability of the mobile application intervention on the System Usability Scale | Describe patient-reported acceptability and ease of use of the mobile application intervention based on scores from the System Usability Scale (score range: 0-100; higher scores indicate greater acceptability and ease of use) | 12 weeks | 
| Compare patient-reported quality of life between study groups on the Functional Assessment of Cancer Therapy-Lung Scale | Compare between study groups patient-reported quality of life based on scores from the Functional Assessment Cancer Therapy-Lung Scale at 12 weeks (score range: 0-136; higher scores indicate better quality of life) | 12 weeks | 
| Compare patient-reported symptoms between study groups on the MD Anderson Symptom Inventory | Compare between study groups patient-reported symptom severity and interference based on scores from the MD Anderson Symptom Inventory at 12 weeks (score range: 0-10 on the symptom severity and interference sub-scales; higher scores indicate worse symptoms) | 12 weeks | 
| Compare patient-reported psychological distress between study groups on the Hospital Anxiety and Depression Scale | Compare between study groups patient-reported anxiety and depression symptoms based on scores from the Hospital Anxiety and Depression Scale at 12 weeks (score range: 0-21 on the anxiety and depression sub-scales; higher scores indicate worse psychological distress) | 12 weeks | 
| Compare patient-reported coping between study groups on the Brief COPE Scale | Compare between study groups patient-reported coping strategies based on scores from the Brief COPE Scale at 12 weeks (score range: 2-8 on each of 14 coping sub-scales; higher scores indicate greater use of that specific coping strategy) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Small Cell Lung Cancer, Portable Electronic Applications, Quality of Life, Coping Skills