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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-06338 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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The research study is to learn how the ACLP can best support patients with stable HR+/HER2- MBC.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACLP Program | Experimental | Participants will take part in the ACLP alone |
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| ACLP Program + Learning Circles | Experimental | Participants will take part in the ACLP and Learning Circles |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Demographics/Lifestyle Survey | Other | Participants will complete all sessions and instruments |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meroe Morse, MD | Contact | 713-794-4053 | mbmorse@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Meroe Morse, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas M. D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D003710 | Demography |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| D017437 |
| Skin and Connective Tissue Diseases |