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A Supportive Care Mobile Application (THRIVE) for the Improvement of Health-Related Outcomes in Patients with Advanced Lung Cancer
Trial Status: active
This clinical trial evaluates a supportive care mobile application (app) (THRIVE) to see how well it works in improving health-related outcomes in patients with lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Patients who are receiving treatment for advanced lung cancer often experience difficult symptoms, such as pain and shortness of breath, as well as emotional distress. However, many patients do not have access to necessary support and symptom management due to a lack of trained clinicians and the challenge of attending numerous clinic visits. The THRIVE mobile app is a self-paced learning app that offers tailored lessons to enhance symptom management and adaptive coping. Using a supportive care mobile app, like THRIVE, may improve health-related outcomes in patients with advanced lung cancer.
Inclusion Criteria
Age >/= 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 = 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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06427954.
I. Evaluate the efficacy of THRIVE versus usual care for improving patient-reported quality of life (QOL), physical symptoms, and psychological outcomes.
II. Evaluate the efficacy of THRIVE versus usual care for improving coping and self-efficacy.
EXPLORATORY OBJECTIVE:
I. Explore mediators and moderators of the intervention effects on patient-reported QOL.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP 1: Patients access the THRIVE mobile app via tablet computer and complete the app intervention lessons in areas of introduction, health, relationships, emotions, lifestyle, and reflection at their desired pace over 10 weeks.
GROUP 2: Patients receive usual oncology care. Following completion of all study procedures, patients may choose to receive access to THRIVE mobile app and complete the app intervention lessons.
After completion of study intervention, patients are followed up at 12 and 24 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
