REJOIN Trial for Older Breast Cancer Survivors

NCT ID: NCT03955627

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2025-07-29

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.

Detailed Description

To improve AIA and AI Adherence in older survivors, it will: first, adapt an evidence-based intervention (AIM 1) and then; test the adapted intervention with breast cancer survivors ≥65 years. The Investigators will educate survivors about possible AI-related side effects and teach survivors ways to use PA to self-manage AIA (AIM 2), and support adherence to hormonal therapy recommendations (AIM 3). Given evidence that survivors experience AIA soon after initiating hormonal therapy, potentially eligible participants would be identified early in the treatment process. By identifying potential participants after diagnosis or during active treatment, survivors would have a minimal delay in beginning the exercise intervention after initiating hormonal therapy (i.e. AIs). All participants will have completed surgery, radiation and/or chemotherapy, which is consistent with current ASCO guidelines for AI use.

Two groups will be randomized to either an information-only group (enhanced standard care) or an education plus exercise group (treatment). At the initial clinical visit during the intervention, participants in both groups will receive printed information along with their AI medication prescription. The treatment group will subsequently receive a one-on-one exercise consultation with a certified exercise trainer (e.g ACSM or similar), followed by a modified version of the Fit & Strong! program, which includes bi-weekly supervised exercise (60 minutes) and educational sessions (30 minutes).

The exercise sessions will include light weights or resistance bands plus low-impact aerobic exercise, in which movements will be explained, demonstrated and modified based on the needs of participants. The exercise protocol will be reviewed and revised based on recommendations from clinical advisers. Educational materials will provide information about the purpose of AI medications (e.g., to reduce cancer recurrence) in layperson language and basic information about potential side effects. As part of in-person sessions, participants will develop a plan to continue exercise at home. Participants can do an activity of their choice (e.g., walking) and use resistance bands which will be provided for the at-home program which will begin after 8 weeks and will include follow up phone calls to assess progress and reinforce the program. Educational sessions will be modified to reflect relevant content and advice for older survivors beginning AIs. Assessments will be taken at 4 and 6 months, with follow up at 12 months.

All supervised exercise sessions will be conducted remotely to accommodate recommended COVID safety protocols.

Conditions

Breast Cancer Female

Keywords

Cancer Treatment Symptoms, Symptom Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Enhanced Standard Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment (Education plus Exercise)

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

REJOIN

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shirley M Bluethmann, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34049837 (View on PubMed)

Other Identifiers

40010042

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00089191

Identifier Type: -

Identifier Source: org_study_id