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

NCT ID: NCT04365569

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-06
• Study Completion Date: 2024-05-16

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Individualized, nutrition and physical activity intervention

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

Group Type: EXPERIMENTAL

Nutrition and physical activity counseling program

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Stone, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center

Weston, Florida, United States

Countries

United States

Other Identifiers

CASE11119

Identifier Type: -

Identifier Source: org_study_id