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Clinical Trials/NCT02963740
NCT02963740CompletedNot Applicable

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

University of Kansas Medical Center2 sites in 1 country11 target enrollmentStarted: November 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
11
Locations
2
Primary Endpoint
Adherence to supervised exercise sessions
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
— to 71 Years (Child, Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.
  • •Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal and track food intake and exercise.

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.

Outcomes

Primary Outcomes

Adherence to supervised exercise sessions

Time Frame: Week 12

Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.

Secondary Outcomes

  • Percent participants meeting physical activity goal(Week 9 to Week 12)
  • Compliance with group telephone sessions(Week 12)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carol Fabian, MD

Professor, Director Breast Cancer Prevention Unit

University of Kansas Medical Center

Study Sites (2)

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