Recruiting

Endocrine TherapyBreast Cancer Endocrine Therapy FITness (BE-FIT) Trial.

Sponsor:

University of British Columbia

Code:

NCT04824339

Conditions

Breast Neoplasms

Eligibility Criteria

Sex: Female

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Immediate Intervention Group

Delayed Intervention Group

Study Details

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.

Conditions

Breast Neoplasms

Study ID

NCT04824339

Start date

Mar 15, 2021

Status verified date

Mar, 2021

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Sex: Female

Age: 19 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate Intervention Group

The 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.

experimental: Delayed Intervention Group

Usual lifestyle control for 8 weeks and then invited to participate in the exercise intervention.

Interventions

Immediate Intervention Group

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.

Delayed Intervention Group

Primary outcome measure

Physical Function [ Time Frame: Change from baseline to week 8 (end of intervention) ]

Central Contacts and Locations

Central contacts

Kelly Mackenzie, MSc

250-897-2609 kelly.mackenzie@ubc.ca

Aaliya Merali-Dewji, MSc

780-242-2706 aaliya.merali@ubc.ca

Locations

Clinical Exercise Physiology Lab

Recruiting

Vancouver, British Columbia, Canada, V6T 1Z3

More Information

Sponsor

University of British Columbia

Last update posted

Apr 1, 2021

Last verified

Mar, 2021

Keywords

Exercise
Adjuvant endocrine therapy
Breast cancer survivor
Virtual Delivery
Reduce side effects

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2021-04-01.