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Completed

NCT Number: NCT02963740

Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors

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..

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Key information

Age range

Up to 71 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/m2.
  • 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.

Treatment and study plan

Supervised exercise

Behavioral

Participants will take part in supervised exercise activities two times per week at a YMCA. Length of the activity will be increased during participation in study. Participants will start at 40 minutes per week and work their way up to 120 minutes per week.

Home-Based Exercise

Behavioral

Aerobic exercise activities to be completed at home. Participants will be asked to start out doing 60 minutes at home and work up to 180 minutes of purposeful aerobic home exercise per week.

Group Phone Calls

Behavioral

Once weekly phone calls that are group-based. The calls will discuss lifestyle changes specific to participants and cover the effects of diet, physical activity, and weight on breast cancer risk, as well as body image and emotional eating.

Diet

Behavioral

Participants will consume a nutritionally balanced, reduced calorie diet as recommended by the Academy of Nutrition and Dietetics.

Primary outcomes

  1. 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

  1. Percent participants meeting physical activity goal

    Time frame: Week 9 to Week 12

    Measured as percentage of participants meeting final physical activity goal between week 9 to week 12. Measurement based off activity tracker participants will wear.

  2. Compliance with group telephone sessions

    Time frame: Week 12

    Defined as number of participants attending at least 75% of the weekly group calls.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 15, 2016
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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