- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04629300
Supportive Care Mobile Application for Patients With NSCLC
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)
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joseph Greer, PHD
- Phone Number: (617) 643-2143
- Email: jgreer2@mgh.harvard.edu
Study Contact Backup
- Name: Jennifer Temel, MD
- Phone Number: (617) 724-0453
- Email: jtemel@mgh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
-
Danvers, Massachusetts, United States, 01923
- Mass General/North Shore Cancer Center
-
Milford, Massachusetts, United States, 01757
- Dana-Farber Brigham Cancer Center at Milford Regional Medical Center
-
Newton, Massachusetts, United States, 02462
- Newton-Wellesley Hospital
-
South Weymouth, Massachusetts, United States, 02190
- Dana-Farber Brigham Cancer Center at South Shore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supportive Care Mobile Application
Complete study questionnaires at two time points:
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. |
Tablet computer with application providing modules on skills for managing symptoms and coping.
Standard oncology care with monitoring of supportive care services usage
|
Active Comparator: Usual Care
Complete study questionnaires at two time points:
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. |
Standard oncology care with monitoring of supportive care services usage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study feasibility based on rates of participant recruitment and completion of assigned study procedures
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph Greer, PHD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-398
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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