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

NCT07236437 | Not Yet Recruiting FDA Device

• 1 other identifier: IIT2024-12-Irwin-LivingWell
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Anxiety; Supportive Care in Cancer; Depression

Keywords

Anxiety; Breast Cancer; Telecoaching; Telehealth; Supportive Care

Outcome Measures

Primary Outcomes (1)

• Study participants total healthcare costs from enrollment to six months compared to controls.

  Healthcare costs will be extracted from electronic medical records. "Healthcare Costs" will include a sum of the costs of the following over a six month timeframe (enrollment to six months): emergency department visits, ICU visits, inpatient hospital charges, unscheduled hospitalizations, hospital days above expected, 30-day readmissions, outpatient visits, diagnostic visits, medications, chemotherapy, immunotherapy, targeted therapies, pathology, imaging, radiation, and any other treatments.

  From baseline assessment to 6-month time point.

Secondary Outcomes (11)

• Study participants total healthcare costs from baseline to 3-months compared to controls.

  From baseline to 3-month time point.

• Study participants total number of healthcare utilization events from baseline to 3-months compared to controls.

  From baseline assessment to 3-month time point.

• Changes in study participant's anxiety scores from baseline to 3 months.

  From baseline to 3 months time point.

• Study participants total healthcare costs from baseline to 12-months compared to controls.

  From baseline to 12-month time point.

• Study participants total number of healthcare utilization events from baseline to 6-months compared to controls.

  From baseline to 6-month time point.

Study Arms (1)

Intervention Arm

EXPERIMENTAL

The intervention arm will participate in the Living Well app modules and telecoaching sessions.

Device: Living Well Program

Interventions

Living Well Program DEVICE

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Breast cancer staging of II-IV
• Moderate to severe anxiety (GAD-7 \>= 10)
• English language proficiency
• Smartphone and ability to use the application as assessed by study staff (IG only)
• Signed dated informed consent form (ICF) within 30 days of diagnosis (IG only)

You may not qualify if:

• 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

Sponsors & Collaborators

• Scott A. Irwin, MD, PhD: lead
• Prosoma: collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Breast Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Scott Irwin, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelica Angelica

CONTACT

3104238969; Angelica.Alderete@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study has one, non-randomized treatment arm. The second arm is retrospectively matched controls.

Study Record Dates

• First Submitted: October 30, 2025
• First Posted: November 19, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)