Finding studies
Finding studies
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Meroe Morse, MD
CONTACT
Lead
M.D. Anderson Cancer Center
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
