Clinical Trial

Living Well Program: Impact on Healthcare Costs and Clinical Outcomes in Breast Cancer Care

Not Yet Recruiting
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Summary
The goal of this study is to evaluate the efficacy and cost-effectiveness of the Living Well Program, a digital therapeutic application with telecoaching support, in breast cancer patients with moderate-to-severe anxiety. The main question the study aims to answer is: does digital cognitive-behavioral therapy-based interventions decrease the overall healthcare costs of patients with stage II to IV breast cancer? The study has one group of participants who will use the Living Well app and telecoaching support. This group will be compared to retroactively matched controls. Over 3 months, patients will complete 21 mental health modules and 5 telecoaching sessions. In the following 3 months, they will complete any outstanding telecoaching sessions and modules while still being monitored, even if they finished all modules and sessions in the first 3 months. The 6 months after that will be the follow-up phase. They will still have access to the Living Well app and may continue to use it, and they will complete the same assessment questionnaires as baseline to identify any changes in their overall mental health.
Trial Details
NCT Number NCT07236437
Lead Sponsor Scott A. Irwin, MD, PhD
Collaborators: Prosoma, Cedars-Sinai Medical Center
Conditions Anxiety, Supportive Care in Cancer, Depression
Enrollment 50 participants
Start Date 2025-11-15
Primary Completion 2027-11-15 (estimated)
Study Completion 2027-11-15 (estimated)
Updated on ClinicalTrials.gov 2025-11-19