Feasibility of High Levels of Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors

University of Kansas Medical Center1 site in 1 country11 target enrollmentNovember 2016

ConditionsBreast Cancer Female

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer Female
Sponsor: University of Kansas Medical Center
Enrollment: 11
Locations: 1
Primary Endpoint: Adherence to supervised exercise sessions
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to demonstrate that breast cancer survivors who need to lose weight are able to follow a weight loss program which combines modest calorie restriction with a graduated activity program..

Detailed Description

Feasibility will be assessed by 1) the number of women that complete the 3--month program; 2) the number of women that can achieve the targeted amount of physical activity per week by the end of the program; and 3) the median amount of physical activity achieved group by all subjects that complete the program.

Registry

clinicaltrials.gov

Start Date

November 2016

End Date

March 2017

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University of Kansas Medical Center

Responsible Party

Principal Investigator

Carol Fabian, MD

Professor, Director Breast Cancer Prevention Unit

University of Kansas Medical Center

Eligibility Criteria

Inclusion Criteria

•Women \< age 71 in good general health.
•Prior diagnosis of breast cancer.
•At least 3 months from completion of any cytotoxic chemotherapy or radiation or surgery. May continue to take endocrine therapy and/or maintenance trastuzumab.
•Body Mass Index (BMI) 30-45 kg/m
•By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface.
•Access to a smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data from these apps viewed by study personnel.
•Live in the greater Kansas City Metropolitan Area
•Willing and able to perform moderate intensity exercise at least 5 days per week for 3 months.
•Willing to perform unsupervised home exercise for the entire 3 months.
•Willing to participate in a weekly behavioral modification group phone call for 3 months.

Exclusion Criteria

•Use of metformin, insulin, steroids or weight loss or anti-psychotic drugs within the prior 3 weeks
•Individuals with prior bariatric surgery procedures
•Need for chronic immunosuppressive drugs
•Participation within the past 6 months on a structured weight loss program such as Weight Watchers®
•Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week.
•Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event.
•Currently receiving investigational agents in a clinical trial.