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

NCT04824339 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2021-04-01

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Delayed 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.

Sponsors & Collaborators

  • British Columbia Cancer Agency

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Kristin L Campbell, PhD · Department of Physical Therapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04824339 on ClinicalTrials.gov