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

NCT07236437 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Living 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.

Sponsors & Collaborators

  • Prosoma

    collaborator UNKNOWN

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • Scott A. Irwin, MD, PhD

    lead OTHER

Principal Investigators

  • Scott Irwin, MD · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-15
Primary Completion
2027-11-15
Completion
2027-11-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07236437 on ClinicalTrials.gov