COMPLETED

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-01-06

Study Completion:2024-05-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04365569

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 \[see Appendix IV\]	* 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.

Inclusion Criteria

Exclusion 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 \[see Appendix IV\]

* 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.

Contacts and Locations

Principal Investigator

Elizabeth Stone, MD

PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Case Comprehensive Cancer Center

Study Locations (Sites)

Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center

Weston, Florida, 33331

United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

Elizabeth Stone, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2021-01-06

Study Completion Date2024-05-16

Study Record Updates

Study Start Date2021-01-06

Study Completion Date2024-05-16

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer