Clinical trial NCT04365569: Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Percent of participants achieving 10% weight loss
timeFrame: At baseline
measure: Percent of participants achieving 10% weight loss
timeFrame: At 3 months
measure: Percent of participants achieving 10% weight loss
timeFrame: At 6 months
measure: Compliance to the recommended dietary pattern
timeFrame: At 3 months
measure: Compliance to physical activity goal
timeFrame: At 6 months
Secondary outcomes:
measure: Body fat percentage
timeFrame: Baseline
measure: Body fat percentage
timeFrame: 3 months
measure: Body fat percentage
timeFrame: 6 months
measure: Glycemic control as measured by HbA1c
timeFrame: At 3 months
measure: Glycemic control as measured by HbA1c
timeFrame: At 6 months
measure: Cholesterol
timeFrame: At 3 months
measure: Cholesterol
timeFrame: At 6 months
measure: Low density lipoprotein
timeFrame: At 3 months
measure: Low density lipoprotein
timeFrame: At 6 months
measure: high density lipoprotein
timeFrame: At 3 months
measure: high density lipoprotein
timeFrame: At 6 months
measure: Triglycerides
timeFrame: At 3 months
measure: Triglycerides
timeFrame: At 6 months
measure: Serum vitamin D
timeFrame: At 3 months
measure: Serum vitamin D
timeFrame: At 6 months
measure: Serum C-reactive protein (CRP)
timeFrame: At 3 months
measure: Serum C-reactive protein (CRP)
timeFrame: At 6 months
measure: Maximum oxygen uptake as measured by VO2 max
timeFrame: Baseline
measure: Maximum oxygen uptake as measured by VO2 max
timeFrame: At 3 months
measure: Maximum oxygen uptake as measured by VO2 max
timeFrame: At 6 months
Other outcomes:
measure: Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
timeFrame: Baseline, 3 months and 6 months
measure: Quality of life as measured by Brief Pain Inventory (BPI)
timeFrame: Baseline, 3 months and 6 months
measure: Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, 3 months and 6 months
measure: Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 3 months and 6 months
measure: Quality of life as measured by NCCN Distress Thermometer
timeFrame: Baseline, 3 months and 6 months
measure: Factors associated with adherence to the program
timeFrame: At 6 months
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center
state: Florida
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Elizabeth Stone, MD
role: PRINCIPAL_INVESTIGATOR
References: