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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorScott A. Irwin, MD, PhD

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

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Scott A. Irwin, MD, PhD

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution

Prosoma

Collaborator

Cedars-Sinai Medical Center

Collaborator