Individualized nutrition and exercise counseling for breast cancer survivors
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
This study is testing a personalized nutrition and exercise program to help overweight breast cancer survivors improve their health and stick to lifestyle changes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Weston, Florida) |
| Trial ID | NCT04365569 on ClinicalTrials.gov |
What this trial studies
This pilot program aims to evaluate the effectiveness of a personalized nutrition and physical activity counseling approach for breast cancer survivors who are overweight. The intervention combines in-person and telephone-based counseling to address the challenges of travel and participation in standard weight loss programs. By focusing on individualized support, the study seeks to improve adherence to recommended lifestyle changes among participants. The program targets breast cancer survivors with a body mass index of 25 or greater, aiming to enhance their overall health and reduce mortality risks associated with obesity.
Who should consider this trial
Good fit: Ideal candidates for this study are breast cancer survivors with a body mass index of 25 or greater who are actively being followed by oncologists at the Maroone Cancer Center.
Not a fit: Patients with a body mass index below 25 or those without a prior history of breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the health outcomes and quality of life for overweight breast cancer survivors.
How similar studies have performed: While similar approaches have been explored, this specific individualized counseling program is a novel intervention targeting the unique needs of overweight breast cancer survivors.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Weston, Florida
- Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center — Weston, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth Stone, MD — Cleveland Clinic, Case Comprehensive Cancer Center
- Study coordinator: Elizabeth Stone, MD
- Email: stonee@ccf.org
- Phone: +1 954-659-5840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.