Metastatic Breast CancerNCT07179809
Group-based Comprehensive Lifestyle Program for Women With Metastatic Breast Cancer
A study testing Demographics/Lifestyle Survey in people with Metastatic Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The research study is to learn how the ACLP can best support patients with stable HR+/HER2- MBC. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Demographics/Lifestyle Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2026to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Meroe Morse, MD, 713-794-4053, mbmorse@mdanderson.org
Meroe Morse, MD
About this study
Official title: Pilot Randomized Trial of a Virtual, Group-based Comprehensive Lifestyle Program for Women With Metastatic Breast Cancer: Exploring Dose of Support to Optimize Adherence
The research study is to learn how the ACLP can best support patients with stable HR+/HER2- MBC.
Read the 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:
- Explore changes in targeted health behaviors of diet, exercise, and stress management.
- Examine changes in patient-reported outcomes (PROs), including: QOL, fatigue, sleep disturbances, mental health, social support, mindfulness, and stages of change.
- 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
- Being tested
- Demographics/Lifestyle Survey
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demographics/Lifestyle SurveyOther
Participants will complete all sessions and instruments
| Study group | Role | What they receive |
|---|---|---|
| ACLP Program | Experimental | Participants will take part in the ACLP alone Receives: Other: Demographics/Lifestyle Survey |
| ACLP Program + Learning Circles | Experimental | Participants will take part in the ACLP and Learning Circles Receives: 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. Receives: Other: Demographics/Lifestyle Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start21 Aug 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meroe Morse, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179809
- Sponsor's protocol ID
- 2025-0951
- Other IDs
- NCI-2025-06338
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial of a Virtual, Group-based Comprehensive Lifestyle Program for Women With Metastatic Breast Cancer: Exploring Dose of Support to Optimize Adherence
- ClinicalTrials.gov ID
- NCT07179809
- Acronym / sponsor ID
- 2025-0951
- Conditions
- Metastatic Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Explore changes in targeted health behaviors of diet, exercise, and stress management.
- Examine changes in patient-reported outcomes (PROs), including: QOL, fatigue, sleep disturbances, mental health, social support, mindfulness, and stages of change.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACLP Program | Experimental | Other: Demographics/Lifestyle SurveyParticipants will take part in the ACLP alone |
| ACLP Program + Learning Circles | Experimental | Other: Demographics/Lifestyle SurveyParticipants will take part in the ACLP and Learning Circles |
| ACLP Program + Learning Circles + Individual Health Coaching | Experimental | Other: Demographics/Lifestyle SurveyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Demographics/Lifestyle SurveyParticipants will complete all sessions and instruments | Other | ACLP Program, ACLP Program + Learning Circles, ACLP Program + Learning Circles + Individual Health Coaching |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meroe Morse, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Demographics/Lifestyle Survey in people with Metastatic Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meroe Morse, MD (713-794-4053, mbmorse@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.