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

NCT04365569 | Completed

• 1 other identifier: CASE11119
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (20)

• Body fat percentage

  Baseline

• Body fat percentage

  3 months

• Body fat percentage

  6 months

• Glycemic control as measured by HbA1c

  At 3 months

• Glycemic control as measured by HbA1c

  At 6 months

Other Outcomes (6)

• Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

  Baseline, 3 months and 6 months

• Quality of life as measured by Brief Pain Inventory (BPI)

  Baseline, 3 months and 6 months

• Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7)

  Baseline, 3 months and 6 months

Study Arms (1)

Individualized, nutrition and physical activity intervention

EXPERIMENTAL

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

Interventions

Nutrition and physical activity counseling program BEHAVIORAL

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

Individualized, nutrition and physical activity intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[see Appendix IV\]

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Elizabeth Stone, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 28, 2020
• Study Start: January 6, 2021
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: September 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)