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NCT04365569 | RECRUITING | Breast Cancer

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

Case Comprehensive Cancer Center

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.

Condition or disease

Breast Cancer

Intervention/treatment

Nutrition and physical activity counseling program

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
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
Actual Study Start Date : 2021-01-06
Estimated Primary Completion Date : 2025-06-01
Estimated Study Completion Date : 2025-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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.
Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program

Location Details

NCT04365569

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How to Participate

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Locations

RECRUITING

United States, Florida

Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center

Weston, Florida, United States, 33331