REJOIN Trial for Older Breast Cancer Survivors
The purpose of this pilot intervention study is to test the effectiveness of a self-management approach (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:
🦠 Breast Cancer Female
🗓️ Study Start (Actual) 15 June 2021
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) March 2025
👥 Enrollment (Estimated) 24
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Winston-Salem, North Carolina, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 60 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 April 2019
  • First Submitted that Met QC Criteria 16 May 2019
  • First Posted 20 May 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 June 2024
  • Last Update Posted 7 June 2024
  • Last Verified June 2024