RecruitingRecruiting
Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer
NCT06427954 · Massachusetts General Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Randomized Trial of Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer
About this study
Multi-site randomized controlled trial of the THRIVE digital health application versus usual care in 250 patients diagnosed with advanced lung cancer within the previous 12 weeks to examine the effect of the intervention on patient-reported QOL, physical symptoms, anxiety and depression symptoms, coping, and self-efficacy. Participants will be randomized in a 1:1 fashion and stratified by study site and lung cancer type to ensure a balanced representation of these factors between the two study groups. The study team will provide iPads to patients assigned to THRIVE and provide instructions on how to use the iPad and digital app. The study team will administer patient-reported outcome measures at enrollment and again at six, 12, and 24 weeks post-enrollment to evaluate the short and long-term impact of THRIVE.
Eligibility criteria
Inclusion Criteria:
* Adults (greater than or equal to 18 years)
* Diagnosed with advanced non-small cell lung cancer (NSCLC) that is not being treated with curative intent or extensive stage small cell lung cancer (SCLC) within the past 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0-2 (i.e., fully active to at least ambulatory and up and about more than 50% of waking hours).
* Sufficient English proficiency to utilize THRIVE in English (Note: patients can complete outcome measures in Spanish if preferred).
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 design
Enrollment target: 250 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-08-06
Estimated completion: 2027-12
Last updated: 2024-11-25
Interventions
Behavioral: Digital Health App
Primary outcomes
- • Functional Assessment of Cancer Therapy - Lung (FACT-L) (12 weeks)
Sponsor
Massachusetts General Hospital · other
With: United States Department of Defense
Contacts & investigators
ContactJennifer Temel · contact · jtemel@partners.org · 6177244000
All locations (3)
University of California Los AngelesRecruiting
Los Angeles, California, United States
Veteran Affairs Greater Los Angeles Health CareNot Yet Recruiting
Los Angeles, California, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States