Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program

Study Overview
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Brief Summary
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More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater than a two-fold increase in mortality compared to women with normal body mass index (BMI). The current standard for weight loss interventions involves in-person counseling. However, this incurs costs related to travel for counseling sessions, potentially limiting program participation, compliance and sustainability.This is a pilot study of an individualized in-person and telephone-based nutrition and exercise counseling program.

Official Title
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Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program on Body Weight, Composition, Cardiovascular Function and Quality of Life in Breast Cancer Survivors

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Nutrition and physical activity counseling program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer diagnosis (stage 0-III) Body mass index of 25mg/k2 or greater Actively being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center Able and willing to participate in nutrition counseling at Maroone Cancer Center Able (cleared by participant's primary oncologist) and willing to perform cardiopulmonary exercise testing Participants must have the ability to understand and the willingness to sign a written informed consent document Performance status 0 or 1 as per ECOG scale [see Appendix IV] Exclusion Criteria: Body mass index below 25kg/m2 No prior history of breast cancer History of metastatic disease Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center Unable or unwilling to participate in nutrition counseling at Maroone Cancer Center Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Participants actively undergoing chemotherapy, immunotherapy or radiation treatment. However, participants currently taking hormonal therapy, such as selective estrogen receptor modulators (SERMS), or aromatase inhibitors, may be included in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized, nutrition and physical activity intervention<br>Initial in-person consult with a registered dietitian, with further in-person follow-ups and monthly telephone consults | Behavioral: Nutrition and physical activity counseling program<br>* 6-month interventional, counseling program based on nutrition and physical activity consisting of: 1. Nutritional counseling by a Registered Dietitian (RD) 2) Implementation of an adequate physical activity program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants achieving 10% weight loss | Efficacy of intervention as assessed by percent of participants achieving 10% weight loss | At baseline | 
| Percent of participants achieving 10% weight loss | Efficacy of intervention as assessed by percent of participants achieving 10% weight loss | At 3 months | 
| Percent of participants achieving 10% weight loss | Efficacy of intervention as assessed by percent of participants achieving 10% weight loss | At 6 months | 
| Compliance to the recommended dietary pattern | Assess compliance to the recommended dietary pattern, diet quality scores will be calculated by the RD after monthly telephone consults or in-person at 3 months and 6 months into the intervention. Each of the 3 elements will be scored from 0-3, resulting in a total score range from 0-9 | At 3 months | 
| Compliance to physical activity goal | Percent of participants complying with proposed activity goal of 150 minutes of moderate intensity physical activity or 75 minutes of vigerous intensity physical activity (or a combination of both) per week over six months | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat percentage | Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis | Baseline | 
| Body fat percentage | Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis | 3 months | 
| Body fat percentage | Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis | 6 months | 
| Glycemic control as measured by HbA1c | Glycemic control as measured by HbA1c | At 3 months | 
| Glycemic control as measured by HbA1c | Glycemic control as measured by HbA1c | At 6 months | 
| Cholesterol | Effect of the intervention on lipid profile as measured by high density cholesterol levels | At 3 months | 
| Cholesterol | Effect of the intervention on lipid profile as measured by high density cholesterol levels | At 6 months | 
| Low density lipoprotein | Effect of the intervention on lipid profile as measured by low density lipoprotein levels | At 3 months | 
| Low density lipoprotein | Effect of the intervention on lipid profile as measured by low density lipoprotein levels | At 6 months | 
| high density lipoprotein | Effect of the intervention on lipid profile as measured by high density lipoprotein levels | At 3 months | 
| high density lipoprotein | Effect of the intervention on lipid profile as measured by high density lipoprotein levels | At 6 months | 
| Triglycerides | Effect of the intervention on lipid profile as measured by triglyceride levels | At 3 months | 
| Triglycerides | Effect of the intervention on lipid profile as measured by triglyceride levels | At 6 months | 
| Serum vitamin D | Effect of the intervention on serum vitamin D | At 3 months | 
| Serum vitamin D | Effect of the intervention on serum vitamin D | At 6 months | 
| Serum C-reactive protein (CRP) | Effect of the intervention on CRP | At 3 months | 
| Serum C-reactive protein (CRP) | Effect of the intervention on CRP | At 6 months | 
| Maximum oxygen uptake as measured by VO2 max | Maximum oxygen uptake as measured by VO2 max | Baseline | 
| Maximum oxygen uptake as measured by VO2 max | Maximum oxygen uptake as measured by VO2 max | At 3 months | 
| Maximum oxygen uptake as measured by VO2 max | Maximum oxygen uptake as measured by VO2 max | At 6 months |