Clinical trial · Interventional
REJOIN Trial for Older Breast Cancer Survivors
Using Exercise to Relieve Arthralgia (Joint Pain) and Improve AI Adherence in Older Survivors (REJOIN): A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Enhanced Standard Care
- description
- Participants will receive standard care, plus a brochure about hormonal therapy use.
- type
- EXPERIMENTAL
- label
- Treatment (Education plus Exercise)
- description
- Participants will receive the same materials as the standard care group, plus participate in group exercise and group discussion sessions.
- interventionNames
- Behavioral: Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN)
Primary outcomes (1)
- measure
- Change in Brief Pain Inventory (Modified for Joint Pain) Scores
- timeFrame
- baseline at 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBluethmann SM, Truica C, Klepin HD, Olsen N, Sciamanna C, Chinchilli VM, Schmitz KH. Study design and methods for the using exercise to relieve joint pain and improve AI adherence in older breast cancer survivors (REJOIN) trial. J Geriatr Oncol. 2021 Sep;12(7):1146-1153. doi: 10.1016/j.jgo.2021.05.011. Epub 2021 May 26. PMID 34049837