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

Case Comprehensive Cancer Center78 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percent of participants achieving 10% weight loss

Efficacy of intervention as assessed by percent of participants achieving 10% weight loss

Time frame: At baseline

Percent of participants achieving 10% weight loss

Efficacy of intervention as assessed by percent of participants achieving 10% weight loss

Time frame: At 3 months

Percent of participants achieving 10% weight loss

Efficacy of intervention as assessed by percent of participants achieving 10% weight loss

Time frame: 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

Time frame: 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

Time frame: At 6 months

Secondary Outcomes

Body fat percentage

Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis

Time frame: Baseline

Body fat percentage

Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis

Time frame: 3 months

Body fat percentage

Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis

Time frame: 6 months

Glycemic control as measured by HbA1c

Time frame: At 3 months

Glycemic control as measured by HbA1c

Time frame: At 6 months

Cholesterol

Effect of the intervention on lipid profile as measured by high density cholesterol levels

Time frame: At 3 months

Cholesterol

Effect of the intervention on lipid profile as measured by high density cholesterol levels

Time frame: At 6 months

Low density lipoprotein

Effect of the intervention on lipid profile as measured by low density lipoprotein levels

Time frame: At 3 months

Low density lipoprotein

Effect of the intervention on lipid profile as measured by low density lipoprotein levels

Time frame: At 6 months

high density lipoprotein

Effect of the intervention on lipid profile as measured by high density lipoprotein levels

Time frame: At 3 months

high density lipoprotein

Effect of the intervention on lipid profile as measured by high density lipoprotein levels

Time frame: At 6 months

Triglycerides

Effect of the intervention on lipid profile as measured by triglyceride levels

Time frame: At 3 months

Triglycerides

Effect of the intervention on lipid profile as measured by triglyceride levels

Time frame: At 6 months

Serum vitamin D

Effect of the intervention on serum vitamin D

Time frame: At 3 months

Serum vitamin D

Effect of the intervention on serum vitamin D

Time frame: At 6 months

Serum C-reactive protein (CRP)

Effect of the intervention on CRP

Time frame: At 3 months

Serum C-reactive protein (CRP)

Effect of the intervention on CRP

Time frame: At 6 months

Maximum oxygen uptake as measured by VO2 max

Time frame: Baseline

Maximum oxygen uptake as measured by VO2 max

Time frame: At 3 months

Maximum oxygen uptake as measured by VO2 max

Time frame: At 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes