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

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

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 Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Nutrition and physical activity counseling program

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Stone, MD; Phone Number: +1 954-659-5840; Email: stonee@ccf.org

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Recruiting
      • Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center
      • Contact: Elizabeth Stone, MD; Phone Number: 954-659-5840; Email: stonee@ccf.org
      • Principal Investigator: Elizabeth Stone, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individualized, nutrition and physical activity intervention; 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; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)	Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B), a 36-item self-report questionnaire to assess the quality of life as reported by breast cancer survivors with scores ranging from 0 to 123, and lower scores indicating better health.	Baseline, 3 months and 6 months
Quality of life as measured by Brief Pain Inventory (BPI)	Quality of life as measured by Brief Pain Inventory (BPI), a 9-item self-administered questionnaire that can evaluate the effect of an individual's pain on their daily functioning. This is a 10-point scale with 0 being the best possible score, meaning "no pain", and 10 being the worst possible score, meaning "pain as bad as you can imagine"	Baseline, 3 months and 6 months
Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7)	Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report questionnaire measuring anxiety which uses a four-point rating scale (ranging from 0 to 3) asking how often in the last two weeks participants have experienced symptoms pertaining to feeling anxious, worried, difficulty relaxing, and irritability. Higher scores indicate higher distress. with a possible score range of 0 to 21 with higher scores indicating worse anxiety.	Baseline, 3 months and 6 months
Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9)	Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9), which objectifies degree of depression severity with a possible score range of 0 to 27 and higher scores indicating worse outcomes	Baseline, 3 months and 6 months
Quality of life as measured by NCCN Distress Thermometer	Quality of life as measured by NCCN Distress Thermometer, which measures distress on a scale of 0 to 10, with higher scores indicating worse distress	Baseline, 3 months and 6 months
Factors associated with adherence to the program	Factors to be assessed include age, race, time since diagnosis, time since last chemotherapy, medical comorbidities and other lifestyle factors such as alcohol consumption and smoking	At 6 months

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Elizabeth Stone, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CASE11119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will share IPD with other researchers within the same institution, but not outside the institution
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No