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

September 25, 2025 updated by: Case Comprehensive Cancer Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Elizabeth Stone, MD
  • Phone Number: +1 954-659-5840
  • Email: stonee@ccf.org

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent of participants achieving 10% weight loss
Time Frame: At baseline
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
At baseline
Percent of participants achieving 10% weight loss
Time Frame: At 3 months
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
At 3 months
Percent of participants achieving 10% weight loss
Time Frame: At 6 months
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
At 6 months
Compliance to the recommended dietary pattern
Time Frame: At 3 months
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
Time Frame: At 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body fat percentage
Time Frame: Baseline
Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis
Baseline
Body fat percentage
Time Frame: 3 months
Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis
3 months
Body fat percentage
Time Frame: 6 months
Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis
6 months
Glycemic control as measured by HbA1c
Time Frame: At 3 months
Glycemic control as measured by HbA1c
At 3 months
Glycemic control as measured by HbA1c
Time Frame: At 6 months
Glycemic control as measured by HbA1c
At 6 months
Cholesterol
Time Frame: At 3 months
Effect of the intervention on lipid profile as measured by high density cholesterol levels
At 3 months
Cholesterol
Time Frame: At 6 months
Effect of the intervention on lipid profile as measured by high density cholesterol levels
At 6 months
Low density lipoprotein
Time Frame: At 3 months
Effect of the intervention on lipid profile as measured by low density lipoprotein levels
At 3 months
Low density lipoprotein
Time Frame: At 6 months
Effect of the intervention on lipid profile as measured by low density lipoprotein levels
At 6 months
high density lipoprotein
Time Frame: At 3 months
Effect of the intervention on lipid profile as measured by high density lipoprotein levels
At 3 months
high density lipoprotein
Time Frame: At 6 months
Effect of the intervention on lipid profile as measured by high density lipoprotein levels
At 6 months
Triglycerides
Time Frame: At 3 months
Effect of the intervention on lipid profile as measured by triglyceride levels
At 3 months
Triglycerides
Time Frame: At 6 months
Effect of the intervention on lipid profile as measured by triglyceride levels
At 6 months
Serum vitamin D
Time Frame: At 3 months
Effect of the intervention on serum vitamin D
At 3 months
Serum vitamin D
Time Frame: At 6 months
Effect of the intervention on serum vitamin D
At 6 months
Serum C-reactive protein (CRP)
Time Frame: At 3 months
Effect of the intervention on CRP
At 3 months
Serum C-reactive protein (CRP)
Time Frame: At 6 months
Effect of the intervention on CRP
At 6 months
Maximum oxygen uptake as measured by VO2 max
Time Frame: Baseline
Maximum oxygen uptake as measured by VO2 max
Baseline
Maximum oxygen uptake as measured by VO2 max
Time Frame: At 3 months
Maximum oxygen uptake as measured by VO2 max
At 3 months
Maximum oxygen uptake as measured by VO2 max
Time Frame: At 6 months
Maximum oxygen uptake as measured by VO2 max
At 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Time Frame: Baseline, 3 months and 6 months
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)
Time Frame: Baseline, 3 months and 6 months
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)
Time Frame: Baseline, 3 months and 6 months
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)
Time Frame: Baseline, 3 months and 6 months
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
Time Frame: Baseline, 3 months and 6 months
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
Time Frame: At 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Case Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Stone, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings