Breast Cancer Endocrine Therapy FITness (BE-FIT) Trial.
1 other identifier
interventional
132
1 country
1
Brief Summary
This project will assess the efficacy of an 8-week virtual exercise program on physical function offered to those with a breast cancer diagnosis currently receiving endocrine therapy. The intervention includes twice-weekly virtual group exercise classes. Participants also complete one to three independent home exercise sessions per week throughout the intervention. Testing will occur virtually at baseline, 8-weeks (at end of program) and follow-up evaluations will be performed at 16-weeks and 12- months after baseline testing. Questionnaires will be administered through REDCap. Exercise sessions and testing will be administered virtually via Zoom.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2021
CompletedFirst Submitted
Initial submission to the registry
March 22, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedApril 1, 2021
March 1, 2021
1.8 years
March 22, 2021
March 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical Function
Measured by 30 second sit to stand test
Change from baseline to week 8 (end of intervention)
Secondary Outcomes (10)
Medication adherence to endocrine therapy
Change from baseline at week 8 (end of intervention), 16 weeks and 12-months
Health-related quality of life
Change from baseline at week 8 (end of intervention), 16 weeks and 12-months
Usual physical activity levels
Change from baseline at week 8 (end of intervention), 16 weeks and 12-months
Weight in kilograms
Change from baseline at week 8 (end of intervention), 16 weeks and 12-months
Height in metres
Change from baseline at week 8 (end of intervention), 16 weeks and 12-months
- +5 more secondary outcomes
Study Arms (2)
Immediate Intervention Group
EXPERIMENTALThe intervention is an 8-week combined aerobic and resistance program, with virtual, group-based, supervised exercise sessions twice per week (60 min). The intervention also includes optional education on healthy eating.
Delayed Intervention Group
EXPERIMENTALUsual lifestyle control for 8 weeks and then invited to participate in the exercise intervention.
Interventions
This study is a partial cross over study. The intervention is 8 weeks in duration. Participants will be randomized to immediate exercise or delayed exercise, and the delayed exercise group will cross over to the intervention after 8 weeks.
This study is a partial cross over study. The intervention is 8 weeks in duration. Participants will be randomized to immediate exercise or delayed exercise, and the delayed exercise group will cross over to the intervention after 8 weeks.
Eligibility Criteria
You may qualify if:
- Stage I - III breast cancer patients who are treated with curative intent
- Completed primary treatment, including surgery, radiation therapy and/or chemotherapy
- Currently receiving adjuvant endocrine therapy (Tamoxifen or an Aromatase Inhibitor) for at least 3 months (to allow for acclimatization) and within 3-years of of staring endocrine therapy.
- Can read and speak English
- Has access to a tablet, smartphone, laptop or computer with built-in video camera
You may not qualify if:
- Not currently receiving endocrine therapy or scheduled to stop within 6 months
- Diagnosed with stage IV breast cancer
- Not willing to attend a twice-weekly exercise program virtually for the duration of the study.
- Not willing to comply with safety measures of virtual programming (to be seen on camera and monitored via video by the instructor)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- British Columbia Cancer Agencycollaborator
Study Sites (1)
Clinical Exercise Physiology Lab
Vancouver, British Columbia, V6T 1Z3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristin L Campbell, PhD
Department of Physical Therapy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 22, 2021
First Posted
April 1, 2021
Study Start
March 15, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2023
Last Updated
April 1, 2021
Record last verified: 2021-03