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Self-Management for Joint Pain in Breast Cancer Survivors (REJOIN Trial)

N/A
Recruiting
Led By Nancy J. Olsen, MD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female, aged ≥ 60 years at the start of study
Diagnosed stages I-III Breast Cancer
Must not have
Presence of metastatic cancer or concurrent malignancy requiring treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a self-management approach combining educational and exercise-based strategies can improve joint pain associated with Aromatase Inhibitors in older breast cancer survivors.

Who is the study for?
This trial is for female breast cancer survivors aged 60 or older who are about to start Aromatase Inhibitors (AI) treatment. They must be able to exercise, have internet access for Zoom sessions, and not be very physically active currently. Those with severe cognitive issues, recent heart problems, joint surgeries, or already on AI therapy for more than 24 weeks can't join.
What is being tested?
The REJOIN Trial tests a self-management program combining education and group exercises aimed at reducing joint pain from AI medication in older breast cancer survivors. Participants will either receive standard care plus information or enter the treatment group with educational classes and exercise sessions.
What are the potential side effects?
While the study itself may not introduce direct side effects, participants should note that Aromatase Inhibitors can cause joint pain which this trial aims to manage through its intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 60 or older.
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My breast cancer is in stage I, II, or III.
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I have finished all my surgery, radiation, and/or chemotherapy treatments.
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I can walk on my own, as confirmed by my doctor.
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I am planning to start aromatase inhibitor therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cancer that has spread or another cancer needing treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Brief Pain Inventory (Modified for Joint Pain) Scores
Secondary study objectives
AI Medication Adherence Percentage
Change in Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire Scores for Older Adults
Change in Exercise Self-efficacy Scale Scores
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment (Education plus Exercise)Experimental Treatment1 Intervention
Participants will receive the same materials as the standard care group, plus participate in group exercise and group discussion sessions.
Group II: Enhanced Standard CareActive Control1 Intervention
Participants will receive standard care, plus a brochure about hormonal therapy use.

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
511 Previous Clinical Trials
2,870,836 Total Patients Enrolled
15 Trials studying Breast Cancer
637 Patients Enrolled for Breast Cancer
Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,478,311 Total Patients Enrolled
39 Trials studying Breast Cancer
1,346,547 Patients Enrolled for Breast Cancer
American Cancer Society, Inc.OTHER
233 Previous Clinical Trials
109,787 Total Patients Enrolled
32 Trials studying Breast Cancer
8,472 Patients Enrolled for Breast Cancer
Nancy J. Olsen, MDPrincipal InvestigatorMilton S. Hershey Medical Center
Shirley M. Bluethmann, PhD, MPHPrincipal InvestigatorMilton S. Hershey Medical Center
Shirley M Bluethmann, MDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN) Clinical Trial Eligibility Overview. Trial Name: NCT03955627 — N/A
Breast Cancer Research Study Groups: Treatment (Education plus Exercise), Enhanced Standard Care
Breast Cancer Clinical Trial 2023: Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN) Highlights & Side Effects. Trial Name: NCT03955627 — N/A
Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03955627 — N/A
~5 spots leftby Dec 2025