REJOIN Trial for Older Breast Cancer Survivors
Keywords
Abstract
Description
To improve AIA and AI Adherence in older survivors, it will: first, adapt an evidence-based intervention (AIM 1) and then; test the adapted intervention with breast cancer survivors ≥65 years. The Investigators will educate survivors about possible AI-related side effects and teach survivors ways to use PA to self-manage AIA (AIM 2), and support adherence to hormonal therapy recommendations (AIM 3). Given evidence that survivors experience AIA soon after initiating hormonal therapy, potentially eligible participants would be identified early in the treatment process. By identifying potential participants after diagnosis or during active treatment, survivors would have a minimal delay in beginning the exercise intervention after initiating hormonal therapy (i.e. AIs). All participants will have completed surgery, radiation and/or chemotherapy, which is consistent with current ASCO guidelines for AI use.
Two groups will be randomized to either an information-only group (enhanced standard care) or an education plus exercise group (treatment). At the initial clinical visit during the intervention, participants in both groups will receive printed information along with their AI medication prescription. The treatment group will subsequently receive a one-on-one exercise consultation with a certified exercise trainer (e.g ACSM or similar), followed by a modified version of the Fit & Strong! program, which includes bi-weekly supervised exercise (60 minutes) and educational sessions (30 minutes).
The exercise sessions will include light weights or resistance bands plus low-impact aerobic exercise, in which movements will be explained, demonstrated and modified based on the needs of participants. The exercise protocol will be reviewed and revised based on recommendations from clinical advisers. Educational materials will provide information about the purpose of AI medications (e.g., to reduce cancer recurrence) in layperson language and basic information about potential side effects. As part of in-person sessions, participants will develop a plan to continue exercise at home. Participants can do an activity of their choice (e.g., walking) and use resistance bands which will be provided for the at-home program which will begin after 8 weeks and will include follow up phone calls to assess progress and reinforce the program. Educational sessions will be modified to reflect relevant content and advice for older survivors beginning AIs. Assessments will be taken at 4 and 6 months, with follow up at 12 months.
For convenience of participants, sessions will take place on the Hershey Medical Campus.
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 04/28/2019 |
| Estimated Enrollment Submitted: | 05/15/2019 |
| First Posted: | 05/19/2019 |
| Last Update Submitted: | 06/09/2020 |
| Last Update Posted: | 06/10/2020 |
| Actual Study Start Date: | 07/27/2020 |
| Estimated Primary Completion Date: | 11/30/2021 |
| Estimated Study Completion Date: | 03/31/2022 |
Condition or disease
Intervention/treatment
Behavioral: Treatment (Education plus Exercise)
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| No Intervention: Enhanced Standard Care Participants will receive standard care, plus a brochure about hormonal therapy use. | |
| Experimental: Treatment (Education plus Exercise) Participants will receive the same materials as the standard care group, plus participate in group exercise and group discussion sessions. | Behavioral: Treatment (Education plus Exercise) Self-management program which includes supervised exercise sessions in groups and group discussions for 8 weeks, following by an 8-week home-based version of the same program. |
Eligibility Criteria
| Ages Eligible for Study | 65 Years To 65 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: 1. Female, aged ≥ 65 years at the start of study 2. Planning to initiate AIs 3. Diagnosed stages I-III Breast Cancer 4. ER+ tumor (at least 5% of cells) 5. Completed surgery, radiation and/or chemotherapy 6. Independent ambulatory (verified by treating clinician/staff) 7. Physician approval to start an exercise program 8. Currently sedentary (>60 min. of physical activity per week) 9. Able to complete surveys and forms/ understand English 10. Agree to random assignment to exercise or control group 11. Can commit to 8 weeks, bi-weekly sessions in person ( if selected for treatment group) 12. Minimum cognitive impairment (verified by cognitive screening questions administered by phone or in-person interview) Exclusion Criteria: 1. Already taking AIs (may participate if 4 weeks or less after initiating) 2. Presence of metastatic cancer or concurrent malignancy requiring treatment 3. Recent history (past 6 months) of stroke/ MI, atrial fibrillation or class 3, 4 heart failure 4. Recent joint surgery or conditions limiting PA |
Outcome
Primary Outcome Measures
1. Brief Pain Inventory [Change in pain experience from baseline at 6 months]
2. AI Medication Adherence [Single measure (percent taken based on what was prescribed over the last 30 days)]
Secondary Outcome Measures
1. Modified Cancer and Aging Research Group (CARG) plus National Health and Nutrition Examination Survey (NHANES) and Patient-Reported Outcomes Measurement Information System (PROMIS) Geriatric Assessment Study Patient Questionnaire [Single Measure (repeated at 4, 6 and 12 months)]
2. Toronto Informational Needs Questionnaire -- Breast Cancer [Single Measure (repeated at 4, 6 and 12 months)]
3. The Exercise Self-efficacy Scale [Single Measure (Repeated at 4, 6 and 12 months)]
