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Exercise Program for Breast Cancer (NEXT-BRCA Trial)
N/A
Waitlist Available
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at intervention completion (approximately 1.3 years)
Awards & highlights
NEXT-BRCA Trial Summary
This trial is testing the feasibility and effectiveness of an exercise and education program for women with breast cancer during chemotherapy.
Who is the study for?
This trial is for English-speaking women over 18 with Stage 1-3 breast cancer who are currently undergoing chemotherapy. They must be cleared by their oncologist to do moderate exercise and live in the community without chronic conditions, cognitive impairments, or injuries that would limit exercise.Check my eligibility
What is being tested?
The study tests a new program combining exercise and education against just education or usual care during chemotherapy. Women will be grouped to compare how these approaches affect their activity levels, strength, mobility, quality of life, health status, and healthcare use.See study design
What are the potential side effects?
Since this trial involves moderate intensity aerobic exercises tailored for individuals undergoing chemotherapy for breast cancer, potential side effects may include typical post-exercise symptoms like muscle soreness or fatigue.
NEXT-BRCA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at intervention completion (approximately 1.3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at intervention completion (approximately 1.3 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in baseline physical activity level
Secondary outcome measures
Change in baseline aerobic capacity
Change in baseline levels of lower extremity strength
Change in baseline levels of resting BP
+5 moreOther outcome measures
Adherence rate to intervention
Drop out rate throughout study
Recruitment rate
+2 moreNEXT-BRCA Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Institution-Based Self-management only (SM)Experimental Treatment2 Interventions
Eight SM sessions for safe and effective exercise strategies will be provided to this group (described above). Four booster sessions will be provided to this group.
Group II: Institution-Based Exercise and Self-Management (EXSM)Experimental Treatment3 Interventions
Eight session of supervised exercise within the cancer institution plus 8 self-management modules focusing on goal setting and action planning for safe and effective exercise strategies (this is based on our team's successful pilot intervention). Four booster sessions will be provided to this group.
Group III: Usual careActive Control1 Intervention
Participants in this group will receive care as normally provided by their treating oncologist. This can be heterogeneous between different physicians and centres, but usually includes oncologists encouraging their patients to 'stay active'
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Booster Sessions
2008
Completed Phase 3
~1090
Exercise
2016
Completed Phase 1
~760
Self-Management
2008
N/A
~140
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Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,908 Total Patients Enrolled
9 Trials studying Breast Cancer
736 Patients Enrolled for Breast Cancer
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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.
Is this research endeavor currently seeking volunteers?
"Affirmative. Clinicaltrials.gov data reveals that recruitment for this study, which commenced on October 3rd 2019, remains ongoing with the most recent update being dated to October 14th 2021. 84 candidates are needed from a single site."
Answered by AI
How extensive is the participant base for this research study?
"Affirmative, clinicaltrials.gov contains records that confirm this medical experiment is currently recruiting subjects. The trial was initiated on October 3rd 2019 and last edited on October 14th 2021; 84 individuals are sought from a single site."
Answered by AI
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