About this trial
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.
Eligibility criteria
Qualifiers
Age 18+
First time breast cancer diagnosis
Established with a Cedars-Sinai Surgical or Medical Oncologist for cancer care and is within 30 days of starting or having started adjuvant or neoadjuvant therapy
Prognosis of greater than 1 year
Disqualifiers
Prior history of different cancer diagnosis or recurrence of the same cancer
Serious mental illness evidenced by patient self-report, chart review and/or diagnosis codes
Presence of suicidal ideation as measured by the Ask Suicide-Screening Questions (ASQ) or a history of suicide attempts as evidenced by self-report or chart review
Current active addiction (drugs, alcohol, etc.) evidenced by Opioid Risk Tool, chart review and/or diagnosis codes
Trial design
Treatments tested in this trial
- Living Well Program
Treatment groups
Sponsors and collaborators
Scott A. Irwin, MD, PhD
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
Prosoma
Collaborator
Cedars-Sinai Medical Center
Collaborator