REJOIN Trial for Older Breast Cancer Survivors (NCT03955627) | Clinical Trial Compass
CompletedNot Applicable
REJOIN Trial for Older Breast Cancer Survivors
United States12 participantsStarted 2021-06-15
Plain-language summary
The purpose of this pilot intervention study is to test the potential effectiveness of a self-management intervention (combining education- and exercise-based strategies) for improving arthralgia (joint pain) associated with Aromatase Inhibitors (AI) in older breast cancer survivors. Survivors will be recruited from local cancer clinics prior to the completion of primary cancer treatment, as arthralgia can occur soon after initiating AI medication. Participants will be randomized to one of two groups: an enhanced standard care group (AI prescription plus information) or a treatment group (educational classes plus group exercise sessions). Older survivors (≥60 years) will be targeted because they are at increased risk of medication complications which may impede adherence. For the baseline assessment, a cancer-specific geriatric assessment will be conducted and a blood sample will be collected to interpret the effects of the self-management study in the context of geriatric experiences. Additionally, there will be an assessment of knowledge, PA habits, and AI-related joint pain and AI adherence. These will be measured again at 4, 6 and at follow up at 12 months.
Who can participate
Age range
60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female, aged ≥ 60 years at the start of study
* Planning to initiate AIs
* Diagnosed stages I-III Breast Cancer
* R+ tumor (at least 5% of cells)
* Completed surgery, radiation and/or chemotherapy
* Independent ambulatory (verified by treating clinician/staff)
* Physician approval to start an exercise program
* Must report insufficient physical activity (\<150 min. of physical activity per week)
* Able to complete surveys and forms/ understand English
* Agree to random assignment to exercise or control group
* Can commit to 8 weeks, bi-weekly classes offered by Zoom video
* Must have internet access and/or data plan by which to participate in Zoom video sessions
* Minimum cognitive impairment (verified by cognitive screening questions administered by phone or in-person interview)
Exclusion Criteria:
* Already taking Aromatase Inhibitors (AIs) (may participate if 24 weeks or less after initiating)
* Presence of metastatic cancer or concurrent malignancy requiring treatment
* Recent history (past 6 months) of stroke/ Myocardial Infarction (MI), atrial fibrillation or class 3, 4 heart failure
* Recent joint surgery or conditions limiting PA
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Brief Pain Inventory (Modified for Joint Pain) Scores