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

NCT ID: NCT07179809

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2029-10-01

Brief 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

Study Design

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

Study Groups

ACLP Program

Participants will take part in the ACLP alone

Group Type: EXPERIMENTAL

Demographics/Lifestyle Survey

Intervention Type: OTHER

Participants will complete all sessions and instruments

ACLP Program + Learning Circles

Participants will take part in the ACLP and Learning Circles

Group Type: EXPERIMENTAL

Demographics/Lifestyle Survey

Intervention Type: OTHER

Participants will complete all sessions and instruments

ACLP Program + Learning Circles + Individual Health Coaching

Participants will take part in the ACLP and in Learning Circles After participants complete the ACLP with Learning Circles, they will receive up to 6 individualized health coaching sessions.

Group Type: EXPERIMENTAL

Demographics/Lifestyle Survey

Intervention Type: OTHER

Participants will complete all sessions and instruments

Interventions

Demographics/Lifestyle Survey

Participants will complete all sessions and instruments

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients with HR+/HER2 negative MBC

2. On first- or second-line treatment

3. Life expectancy at least 12 months

4. Only females

5. Age 18 years or older

6. Able to read, write, and speak English

7. Willingness to follow protocol requirements

8. Have a smartphone with access to cellular service or computer access with internet service

9. Oriented to person, place, and time

10. Consume less than 3 servings of fruit and vegetable/day

11. Engage in less than 150 minutes moderate/vigorous intensity activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling)

12. Engage in a mind-body practice less than 4 times a month

Exclusion Criteria

1. Another primary cancer diagnosis within past 5 years (not including non-melanoma skin cancers)

2. Any major thought disorder (e.g., schizophrenia, dementia)

3. Communication barriers (e.g., hard of hearing)

4. Poorly-controlled or uncontrolled diabetes in the opinion of the physician(s)

5. Extreme mobility issues (e.g., unable to get in and out of a chair unassisted)

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

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meroe Morse, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Central Contacts

Meroe Morse, MD

Role: CONTACT

mbmorse@mdanderson.org

713-794-4053

Facility Contacts

Meroe Morse, MD

Role: primary

mbmorse@mdanderson.org

713-794-4053

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2025-06338

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0951

Identifier Type: -

Identifier Source: org_study_id