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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 Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Can commit to 8 weeks, bi-weekly classes offered by Zoom video
Female, aged ≥ 60 years at the start of study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
REJOIN Trial 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.Check my eligibility
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.See study design
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.
REJOIN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can attend bi-weekly Zoom classes for 8 weeks.
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I am a woman aged 60 or older.
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I agree to be randomly placed in an exercise or control group.
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I have internet or a data plan for Zoom video calls.
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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.
Select...
I am planning to start aromatase inhibitor therapy.
REJOIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Brief Pain Inventory (Modified for Joint Pain) Scores
Secondary outcome measures
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 moreREJOIN 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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,235 Previous Clinical Trials
1,001,972 Total Patients Enrolled
32 Trials studying Breast Cancer
5,020 Patients Enrolled for Breast Cancer
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,433 Total Patients Enrolled
33 Trials studying Breast Cancer
8,884 Patients Enrolled for Breast Cancer
Milton S. Hershey Medical CenterLead Sponsor
491 Previous Clinical Trials
2,798,781 Total Patients Enrolled
14 Trials studying Breast Cancer
605 Patients Enrolled for Breast Cancer
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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: Enhanced Standard Care
- Group 2: Treatment (Education plus Exercise)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many test subjects are participating in this experiment?
"Affirmative. Clinicaltrials.gov displays that this research trial is actively recruiting eligible participants, with initial postings on June 15th 2021 and the latest update from April 27th 2022. Only 24 individuals are needed at one site for this investigation."
Answered by AI
Are applications still being received for this experiment?
"As indicated on clinicaltrials.gov, this experimental trial is currently looking for participants with the posting first appearing June 15th 2021 and most recently updated April 27th 2022."
Answered by AI
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