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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02963740
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE November 10, 2016
First Posted Date  ICMJE November 15, 2016
Last Update Posted Date February 6, 2019
Study Start Date  ICMJE November 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02963740 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2016)
  • 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.
  • Compliance with group telephone sessions [ Time Frame: Week 12 ]
    Defined as number of participants attending at least 75% of the weekly group calls.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors
Official Title  ICMJE Feasibility of High Levels of Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer Female
Intervention  ICMJE
  • Behavioral: Supervised Exercise
    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.
  • Behavioral: Home-based Exercise
    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.
  • Behavioral: Group Phone Calls
    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.
  • Behavioral: Diet
    Participants will consume a nutritionally balanced, reduced calorie diet as recommended by the Academy of Nutrition and Dietetics.
Study Arms  ICMJE Experimental: Weight Loss Intervention Group
Participants will take part in supervised exercise and home-based exercise sessions. Participants will be asked to follow a specific diet. Participants will be asked to take part in weekly behavioral group phone calls.
Interventions:
  • Behavioral: Supervised Exercise
  • Behavioral: Home-based Exercise
  • Behavioral: Group Phone Calls
  • Behavioral: Diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2017)
11
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2016)
20
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 71 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02963740
Other Study ID Numbers  ICMJE STUDY00004575
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carol Fabian, MD, University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carol Fabian, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP