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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Nutrition and physical activity counseling program

Study type: Interventional

Funder types: Other

Identifiers

NCT04365569

CASE11119

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Individualized, nutrition and physical activity intervention

Experimental group

Description:

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

Treatment:

Behavioral: Nutrition and physical activity counseling program