NCT07179809

Group-based Comprehensive Lifestyle Program for Women With Metastatic Breast Cancer

Pilot Randomized Trial of a Virtual, Group-based Comprehensive Lifestyle Program for Women With Metastatic Breast Cancer: Exploring Dose of Support to Optimize Adherence

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The research study is to learn how the ACLP can best support patients with stable HR+/HER2- MBC.

Detailed description

Primary Objective: Assess the feasibility of delivering the ACLP, ACLP-LC, and ACLP-LC-IHC programs in stable HR+/HER2- MBC survivors. Feasibility criteria will include the percent of eligible patients who consent to participate (feasibility is defined as 30% of those approached and are eligible end up consenting) and study retention by the last follow-up (feasibility is defined as 50% of those randomized remaining in the study and who participated in at least 75% of online sessions). Our working hypothesis is that the provision of the evidence-based, mHeath ACLP with the Learning Circle support group, with or without individual health coaching, is feasible in patients with stable HR+/HER2- MBC. Secondary Objectives: 1. Explore changes in targeted health behaviors of diet, exercise, and stress management. 2. Examine changes in patient-reported outcomes (PROs), including: QOL, fatigue, sleep disturbances, mental health, social support, mindfulness, and stages of change. 3. Examine if there are group differences in post-intervention albumin, vit D, and magnesium levels. OUTLINE: Patients are first randomized to 1 of 3 groups. GROUP 1 (ACLP): Patients receive an outline of tasks and complete ACLP interactive exercise and activity modules on their own over 8 weeks and receive calls weekly for 8 weeks. GROUP 2 (ACLP-LC): Patients complete ACLP interactive exercise and activity modules and attend online LC group sessions over 90 minutes once weekly (QW) for 8 weeks. Patients receive informational emails weekly prior to scheduled sessions. GROUP 3 (ACLP-LC-IHC): Patients participate in the 8-week ACLP-LC program just like group 2. In addition, starting two weeks after the end of the program, they receive IHC sessions over 30-60 minutes for up to 6 sessions over 3 months. Additionally, patients undergo blood sample collection throughout the study. After completion of study treatment, patients are followed at 3 and 6 months.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
OTHER	Demographics/Lifestyle Survey	Participants will complete all sessions and instruments

Timeline

• Start date: 2026-02-28
• Primary completion: 2027-10-01
• Completion: 2029-10-01
• First posted: 2025-09-18
• Last updated: 2025-09-18

Locations

1 site across 1 country: United States