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

NCT07179809 | Not Yet Recruiting DMC

• 2 other identifiers: 2025-0951NCI-2025-06338
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (3)

ACLP Program

EXPERIMENTAL

Participants will take part in the ACLP alone

Other: Demographics/Lifestyle Survey

ACLP Program + Learning Circles

EXPERIMENTAL

Participants will take part in the ACLP and Learning Circles

Other: Demographics/Lifestyle Survey

ACLP Program + Learning Circles + Individual Health Coaching

EXPERIMENTAL

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.

Other: Demographics/Lifestyle Survey

Interventions

Demographics/Lifestyle Survey OTHER

Participants will complete all sessions and instruments

ACLP Program; ACLP Program + Learning Circles; ACLP Program + Learning Circles + Individual Health Coaching

Eligibility Criteria

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

You may qualify if:

• Patients with HR+/HER2 negative MBC
• On first- or second-line treatment
• Life expectancy at least 12 months
• Only females
• Age 18 years or older
• Able to read, write, and speak English
• Willingness to follow protocol requirements
• Have a smartphone with access to cellular service or computer access with internet service
• Oriented to person, place, and time
• Consume less than 3 servings of fruit and vegetable/day
• 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)
• Engage in a mind-body practice less than 4 times a month

You may not qualify if:

• Another primary cancer diagnosis within past 5 years (not including non-melanoma skin cancers)
• Any major thought disorder (e.g., schizophrenia, dementia)
• Communication barriers (e.g., hard of hearing)
• Poorly-controlled or uncontrolled diabetes in the opinion of the physician(s)
• Extreme mobility issues (e.g., unable to get in and out of a chair unassisted)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Demography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Meroe Morse, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meroe Morse, MD

CONTACT

713-794-4053; mbmorse@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 18, 2025
• Study Start: February 28, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

US (1)