Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors
- Conditions
- Breast Cancer Female
- Interventions
- Behavioral: Supervised ExerciseBehavioral: Home-based ExerciseBehavioral: Group Phone CallsBehavioral: Diet
- Registration Number
- NCT02963740
- Lead Sponsor
- 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..
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 11
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Weight Loss Intervention Group Home-based Exercise 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. Weight Loss Intervention Group Diet 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. Weight Loss Intervention Group Supervised Exercise 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. Weight Loss Intervention Group Group Phone Calls 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.
- Primary Outcome Measures
Name Time Method Adherence to supervised exercise sessions Week 12 Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.
- Secondary Outcome Measures
Name Time Method Percent participants meeting physical activity goal 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 Week 12 Defined as number of participants attending at least 75% of the weekly group calls.
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States