Overview
The research study is to learn how the ACLP can best support patients with stable HR+/HER2- MBC.
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
