REJOIN Trial for Older Breast Cancer Survivors
Completed · Not applicable
Conditions studied: Breast Cancer Female
In brief
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.
Key facts
- Study ID
- NCT03955627
- Run by
- Wake Forest University Health Sciences
- People needed
- 12
- Starts
- 2021-06-15
- Expected to finish
- 2025-07-29
- Last updated by the study team
- 2026-06-01
Who can join
Age: 60 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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