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)
1 other identifier
interventional
120
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2021
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
November 16, 2020
CompletedStudy Start
First participant enrolled
October 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedNovember 22, 2024
November 1, 2024
2.3 years
October 28, 2020
November 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Patient-reported acceptability and usability of the mobile application intervention on the System Usability Scale
12 weeks
Compare patient-reported quality of life between study groups on the Functional Assessment of Cancer Therapy-Lung Scale
12 weeks
Compare patient-reported symptoms between study groups on the MD Anderson Symptom Inventory
12 weeks
Compare patient-reported psychological distress between study groups on the Hospital Anxiety and Depression Scale
12 weeks
Compare patient-reported coping between study groups on the Brief COPE Scale
12 weeks
Study Arms (2)
Supportive Care Mobile Application
EXPERIMENTALComplete 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.
Usual Care
ACTIVE COMPARATORComplete 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.
Interventions
Tablet computer with application providing modules on skills for managing symptoms and coping.
Standard oncology care with monitoring of supportive care services usage
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923, United States
Dana-Farber Brigham Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, 01757, United States
Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
Dana-Farber Brigham Cancer Center at South Shore
South Weymouth, Massachusetts, 02190, United States
Related Publications (1)
Waldman LP, Centracchio JA, Jacobs JM, Petrillo LA, El-Jawahri AR, Temel JS, Greer JA. Study protocol for a 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. Front Psychol. 2023 Jun 22;14:1184482. doi: 10.3389/fpsyg.2023.1184482. eCollection 2023.
PMID: 37425161DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Greer, PHD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 28, 2020
First Posted
November 16, 2020
Study Start
October 15, 2021
Primary Completion
February 9, 2024
Study Completion
July 31, 2024
Last Updated
November 22, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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
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.