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

ConditionMetastatic Breast Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with HR+/HER2 negative MBC

On first- or second-line treatment

Life expectancy at least 12 months

Only females

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

Demographics/Lifestyle Survey
Other intervention
Participants will complete all sessions and instruments

Treatment groups

100 Participants

are divided into 3 treatment groups

Group A: ACLP ProgramExperimental treatment 1 intervention

Group B: ACLP Program + Learning CirclesExperimental treatment 1 intervention

Group C: ACLP Program + Learning Circles + Individual Health CoachingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Through study completion; an average of 1 year.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

Apply now