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

NCT ID: NCT07236437

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-15
• Study Completion Date: 2027-11-15

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.

Detailed 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 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.

Conditions

Anxiety; Supportive Care in Cancer; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Arm

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

Group Type: EXPERIMENTAL

Living Well Program

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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 different cancer diagnosis or recurrence of the same cancer

2. Serious mental illness evidenced by patient self-report, chart review and/or diagnosis codes

3. 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

4. Current active addiction (drugs, alcohol, etc.) evidenced by Opioid Risk Tool, chart review and/or diagnosis codes

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prosoma

UNKNOWN

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: collaborator

Scott A. Irwin, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Scott A. Irwin, MD, PhD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Scott Irwin, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Central Contacts

Angelica Angelica

Role: CONTACT

Angelica.Alderete@cshs.org

3104238969

Facility Contacts

Angelica Alderete

Role: primary

Angelica.Alderete@cshs.org

3104238969

Other Identifiers

IIT2024-12-Irwin-LivingWell

Identifier Type: -

Identifier Source: org_study_id