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

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 in reducing anxiety and depression in cancer patients. There are minimal known potential risk: primarily, the potential for psychological distress associated with responding to questions about health status and employment. Known potential benefits to patients in the intervention group include immediate psychological well-being improvements and decreased anxiety associated with breast cancer diagnosis and treatment. Long term, patients may develop improved coping and emotional regulations skills that persist beyond the study period. These skills may enhance quality of life and improve treatment adherence and outcomes. More broadly, this study may offer societal benefits through an improved understanding of digital therapeutic interventions in oncology care. Economic analyses from this study may provide insights to the cost-effectiveness of digital interventions in healthcare. This trial utilizes retrospectively matched controls based on key demographic and clinical characteristics as a comparison group to the intervention group. Use of retrospectively matched controls was chosen due to the nature of the intervention and the target population. Given that the Living Well Program is a digital therapeutic intervention aimed at addressing a significant unmet need in cancer care, it was deemed ethically preferable to offer the intervention to all eligible participants rather than withholding it from a control group. The intervention consists of 21 modules in the mobile application, and five 20-minute telecoaching sessions. Participants begin with the first module upon enrollment and are asked to complete one module every other day, or as needed, with each module taking 15-30 minutes. This regimen is designed to be completed over a 6-month period, constituting the planned maximum dosage. The 15-30-minute module duration aims to provide meaningful engagement without overburdening patients undergoing cancer treatment. The 3-month active intervention period aligns with typical durations of effective cognitive-behavioral therapy interventions, while extended 12-month access to the application allows for continued support and skill reinforcement. The inclusion of five telecoaching sessions for the first six months provides human support to complement the digital intervention, an approach shown to enhance engagement and outcomes in digital mental health interventions. The baseline assessment will include comprehensive demographic and medical history questionnaire, treatment history and sociodemographic factors. Patients will complete validated psychometric scales to assess their quality of life and mental health, including the Generalized Anxiety Disorder-7 (GAD-7) to measure anxiety symptoms, Patient Health Questionnaire-9 (PHQ-9) to measure depression symptoms, PROMIS-29 to assess quality of life, and the Edmonton Symptom Assessment System (ESAS) to assess physical symptoms. They will also complete the Cedars-Sinai Wellbeing Screen and 10-Point Distress thermometer. These assessments provide baseline measures of participants overall mental health. The intervention will be administered through a smartphone app called The Living Well Program. A study team member will assist with installation and configuration of the app so patients can complete modules and engage in telecoaching sessions. Follow-up assessments at 3-, 6-, and 12-months post-baseline will include the same questionnaires as the baseline assessment, collection of healthcare costs and utilization from medical records, assessment of concomitant medications, and evaluation of intervention adherence and engagement metrics from the app.