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

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.

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

Conditions
-----------------
Breast Cancer Female

Intervention / Treatment
-----------------
* Behavioral: Supervised Exercise
* Behavioral: Home-based Exercise
* Behavioral: Group Phone Calls
* Behavioral: Diet


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Maximum Age: 71 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Loss Intervention Group<br>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<br>* 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.<br>Behavioral: Home-based Exercise<br>* 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.<br>Behavioral: Group Phone Calls<br>* 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.<br>Behavioral: Diet<br>* Participants will consume a nutritionally balanced, reduced calorie diet as recommended by the Academy of Nutrition and Dietetics.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to supervised exercise sessions | Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent participants meeting physical activity goal | Measured as percentage of participants meeting final physical activity goal between week 9 to week 12. Measurement based off activity tracker participants will wear. | Week 9 to Week 12 | 
| Compliance with group telephone sessions | Defined as number of participants attending at least 75% of the weekly group calls. | Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer survivor, weight loss program