REJOIN Trial for Older Breast Cancer Survivors

NCT03955627 | Completed

• 2 other identifiers: IRB0008919140010042
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Cancer Treatment Symptoms, Symptom Management

Outcome Measures

Primary Outcomes (1)

• Change in Brief Pain Inventory (Modified for Joint Pain) Scores

  The Brief Pain Inventory - Short Form (BPI-sf) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The BPI-sf is a modification of the Brief Pain Inventory - Long Form, which includes additional questions on demographics (date of birth, marital status, education, employment), pain history, aggravating and easing factors, treatment and medication, pain quality, and response to treatment. Higher scores indicate greater severity and more interference.

  baseline at 12 months

Secondary Outcomes (6)

• AI Medication Adherence Percentage

  Day 30

• Change in Toronto Informational Needs Questionnaire (TINQ) Scores -- Breast Cancer

  Month 12

• Change in 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

  Month 12

• Change in Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire Scores for Older Adults

  Month 12

• Change in Exercise Self-efficacy Scale Scores

  Month 12

Study Arms (2)

Enhanced Standard Care

NO INTERVENTION

Participants will receive standard care, plus a brochure about hormonal therapy use.

Treatment (Education plus Exercise)

EXPERIMENTAL

Participants will receive the same materials as the standard care group, plus participate in group exercise and group discussion sessions.

Behavioral: Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN)

Interventions

Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN) BEHAVIORAL

Self-management program which includes supervised exercise sessions in groups and group discussions for 8 weeks conducted by Zoom video, followed by an 8-week home-based version of the same program participants do on their own with bi-weekly coaching calls.

Also known as: REJOIN

Treatment (Education plus Exercise)

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: Participants must be biologically female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Bluethmann 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 DERIVED

Study Officials

• Shirley M Bluethmann, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Masked parties will not be told the arm to which the participant is assigned. Patient study records will indicate if they are in the study, but not the arm assignment. All participants will receive standard information about AI use and participate in four assessments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Pilot. Enhanced Standard Care v. Treatment (education plus exercise).

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 20, 2019
• Study Start: June 15, 2021
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)