Supportive Care Mobile Application for Patients With NSCLC

• ClinicalTrials.gov Identifier: NCT04629300
• Recruitment Status: Active, not recruiting
• First Posted: November 16, 2020
• Last Update Posted: January 3, 2024
• Sponsor: Massachusetts General Hospital
• Collaborator: National Comprehensive Cancer Network
• Information provided by (Responsible Party): Joseph A. Greer, Ph.D., Massachusetts General Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Non Small Cell Lung Cancer; Quality of Life; Coping Skills	Behavioral: Supportive Care Mobile Application; Other: Usual Care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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)
• Actual Study Start Date: October 15, 2021
• Estimated Primary Completion Date: February 15, 2024
• Estimated Study Completion Date: February 15, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Supportive Care Mobile Application; 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; 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
Active Comparator: Usual Care; 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; Standard oncology care with monitoring of supportive care services usage

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. 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)
2. 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)
3. 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)
4. 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)
5. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02114

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Mass General/North Shore Cancer Center

Danvers, Massachusetts, United States, 01923

Dana-Farber Brigham Cancer Center at Milford Regional Medical Center

Milford, Massachusetts, United States, 01757

Newton-Wellesley Hospital

Newton, Massachusetts, United States, 02462

Dana-Farber Brigham Cancer Center at South Shore

South Weymouth, Massachusetts, United States, 02190

Sponsors and Collaborators

Massachusetts General Hospital

National Comprehensive Cancer Network

Investigators

• Principal Investigator: Joseph Greer, PHD; Massachusetts General Hospital

More Information

• Responsible Party: Joseph A. Greer, Ph.D., Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04629300
• Other Study ID Numbers: 20-398
• First Posted: November 16, 2020
• Last Update Posted: January 3, 2024
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joseph A. Greer, Ph.D., Massachusetts General Hospital:

Non Small Cell Lung Cancer; Portable Electronic Applications; Quality of Life; Coping Skills

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms