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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 belowSelect...
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:Select...
I have cancer that has spread or another cancer needing treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can attend bi-weekly Zoom classes for 8 weeks.I am a woman aged 60 or older.I have internet or a data plan for Zoom video calls.I started taking Aromatase Inhibitors less than 6 months ago.My breast cancer is in stage I, II, or III.I recently had joint surgery or have a condition that limits my physical activity.I have finished all my surgery, radiation, and/or chemotherapy treatments.I agree to be randomly placed in an exercise or control group.I can walk on my own, as confirmed by my doctor.You don't engage in enough physical activity, less than 150 minutes per week.I am planning to start aromatase inhibitor therapy.I have not had a stroke, heart attack, severe heart failure, or irregular heartbeat in the last 6 months.The tumor has a high amount (at least 5%) of R+ cells.I have cancer that has spread or another cancer needing treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Education plus Exercise)
- Group 2: Enhanced Standard Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.