Living Well Program: Impact on Healthcare Costs and Clinical Outcomes in Breast Cancer Care
Scott A. Irwin, MD, PhD
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.
Description
This is a prospective, non-randomized, historically controlled interventional study. It will evaluate the effectiveness and healthcare impacts of a digital cognitive-behavioral therapy-based intervention for anxiety in patients with stage II to IV breast cancer. The high prevalence of anxiety among cancer patients with limited access to mental health support drives higher total healthcare costs, healthcare services utilization, and worse clinical outcomes. This is one of the major rationales for the study. There have been promising preliminary results from previous studies of this intervention…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18+ 2. First time breast cancer diagnosis 3. 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 4. Prognosis of greater than 1 year 5. Breast cancer staging of II-IV 6. Moderate to severe anxiety (GAD-7 \>= 10) 7. English language proficiency 8. Smartphone and ability to use the application as assessed by study staff (IG only) 9. Signed dated informed consent form (ICF) within 30 days of diagnosis (IG only) Exclusion Criteria: 1. Prior history of differe…
Interventions
- DeviceLiving Well Program
The intervention is multicomponent, including a mobile application and telecoaching. The mobile application is comprised of 21 modules integrating psychoeducation and cognitive-behavioral therapy principles, designed to be completed in 3 months. Modules require 15-30 minutes to complete and address topics such as breast cancer education, anxiety management, and adaptive coping strategies. Telecoaching services will provide personalized support for cancer patients throughout their treatment. Participants will complete five 20-30 minute telecoaching sessions with qualified mental health professionals over 6 months. Outcomes will be compared to a retrospective control cohort.
Location
- Cedars-Sinai Medical CenterLos Angeles, California