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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

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..

Condition or disease Intervention/treatment Phase
Breast Cancer Female Behavioral: Supervised Exercise Behavioral: Home-based Exercise Behavioral: Group Phone Calls Behavioral: Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility of High Levels of Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors
Study Start Date : November 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 71 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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/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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963740


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Carol Fabian, MD University of Kansas Medical Center

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Responsible Party: Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02963740    
Other Study ID Numbers: STUDY00004575
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Carol Fabian, MD, University of Kansas Medical Center:
breast cancer survivor
weight loss program
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases