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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition and physical activity counseling program
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cleveland Clinic Florida Weston, Case Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Individualized, nutrition and physical activity intervention

Arm Description

Initial in-person consult with a registered dietitian, with further in-person follow-ups and monthly telephone consults

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2020
Last Updated
July 24, 2023
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04365569
Brief Title
Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individualized, nutrition and physical activity intervention
Arm Type
Experimental
Arm Description
Initial in-person consult with a registered dietitian, with further in-person follow-ups and monthly telephone consults
Intervention Type
Behavioral
Intervention Name(s)
Nutrition and physical activity counseling program
Intervention Description
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
Primary Outcome Measure Information:
Title
Percent of participants achieving 10% weight loss
Description
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
Time Frame
At baseline
Title
Percent of participants achieving 10% weight loss
Description
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
Time Frame
At 3 months
Title
Percent of participants achieving 10% weight loss
Description
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
Time Frame
At 6 months
Title
Compliance to the recommended dietary pattern
Description
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
Title
Compliance to physical activity goal
Description
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 Outcome Measure Information:
Title
Body fat percentage
Description
Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis
Time Frame
Baseline
Title
Body fat percentage
Description
Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis
Time Frame
3 months
Title
Body fat percentage
Description
Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis
Time Frame
6 months
Title
Glycemic control as measured by HbA1c
Description
Glycemic control as measured by HbA1c
Time Frame
At 3 months
Title
Glycemic control as measured by HbA1c
Description
Glycemic control as measured by HbA1c
Time Frame
At 6 months
Title
Cholesterol
Description
Effect of the intervention on lipid profile as measured by high density cholesterol levels
Time Frame
At 3 months
Title
Cholesterol
Description
Effect of the intervention on lipid profile as measured by high density cholesterol levels
Time Frame
At 6 months
Title
Low density lipoprotein
Description
Effect of the intervention on lipid profile as measured by low density lipoprotein levels
Time Frame
At 3 months
Title
Low density lipoprotein
Description
Effect of the intervention on lipid profile as measured by low density lipoprotein levels
Time Frame
At 6 months
Title
high density lipoprotein
Description
Effect of the intervention on lipid profile as measured by high density lipoprotein levels
Time Frame
At 3 months
Title
high density lipoprotein
Description
Effect of the intervention on lipid profile as measured by high density lipoprotein levels
Time Frame
At 6 months
Title
Triglycerides
Description
Effect of the intervention on lipid profile as measured by triglyceride levels
Time Frame
At 3 months
Title
Triglycerides
Description
Effect of the intervention on lipid profile as measured by triglyceride levels
Time Frame
At 6 months
Title
Serum vitamin D
Description
Effect of the intervention on serum vitamin D
Time Frame
At 3 months
Title
Serum vitamin D
Description
Effect of the intervention on serum vitamin D
Time Frame
At 6 months
Title
Serum C-reactive protein (CRP)
Description
Effect of the intervention on CRP
Time Frame
At 3 months
Title
Serum C-reactive protein (CRP)
Description
Effect of the intervention on CRP
Time Frame
At 6 months
Title
Maximum oxygen uptake as measured by VO2 max
Description
Maximum oxygen uptake as measured by VO2 max
Time Frame
Baseline
Title
Maximum oxygen uptake as measured by VO2 max
Description
Maximum oxygen uptake as measured by VO2 max
Time Frame
At 3 months
Title
Maximum oxygen uptake as measured by VO2 max
Description
Maximum oxygen uptake as measured by VO2 max
Time Frame
At 6 months
Other Pre-specified Outcome Measures:
Title
Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Description
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.
Time Frame
Baseline, 3 months and 6 months
Title
Quality of life as measured by Brief Pain Inventory (BPI)
Description
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"
Time Frame
Baseline, 3 months and 6 months
Title
Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7)
Description
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.
Time Frame
Baseline, 3 months and 6 months
Title
Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9)
Description
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
Time Frame
Baseline, 3 months and 6 months
Title
Quality of life as measured by NCCN Distress Thermometer
Description
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
Time Frame
Baseline, 3 months and 6 months
Title
Factors associated with adherence to the program
Description
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
Time Frame
At 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Stone, MD
Phone
+1 954-659-5840
Email
stonee@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Stone, MD
Organizational Affiliation
Cleveland Clinic, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Stone, MD
Phone
954-659-5840
Email
stonee@ccf.org
First Name & Middle Initial & Last Name & Degree
Elizabeth Stone, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Will share IPD with other researchers within the same institution, but not outside the institution

Learn more about this trial

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

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