Supportive Care Mobile Application for Patients With NSCLC

Quality of Life Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04629300
• Other study ID #: 20-398
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: February 15, 2024

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Coping Skills
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Quality of Life

Intervention

Behavioral:
• Supportive Care Mobile Application
Tablet computer with application providing modules on skills for managing symptoms and coping.

Other:
• Usual Care
Standard oncology care with monitoring of supportive care services usage

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Mass General/North Shore Cancer Center	Danvers	Massachusetts
United States	Dana-Farber Brigham Cancer Center at Milford Regional Medical Center	Milford	Massachusetts
United States	Newton-Wellesley Hospital	Newton	Massachusetts
United States	Dana-Farber Brigham Cancer Center at South Shore	South Weymouth	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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