Breast Cancer
Conditions
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.
Interventions
BEHAVIORALNutrition and physical activity counseling program
6-month interventional, counseling program based on nutrition and physical activity consisting of: 1\. Nutritional counseling by a Registered Dietitian (RD) 2) Implementation of an adequate physical activity program
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants achieving 10% weight loss | At baseline | Efficacy of intervention as assessed by percent of participants achieving 10% weight loss |
| Compliance to physical activity goal | At 6 months | Percent of participants complying with proposed activity goal of 150 minutes of moderate intensity physical activity or 75 minutes of vigerous intensity physical activity (or a combination of both) per week over six months |
| Compliance to the recommended dietary pattern | At 3 months | Assess compliance to the recommended dietary pattern, diet quality scores will be calculated by the RD after monthly telephone consults or in-person at 3 months and 6 months into the intervention. Each of the 3 elements will be scored from 0-3, resulting in a total score range from 0-9 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low density lipoprotein | At 3 months | Effect of the intervention on lipid profile as measured by low density lipoprotein levels |
| Cholesterol | At 3 months | Effect of the intervention on lipid profile as measured by high density cholesterol levels |
| high density lipoprotein | At 3 months | Effect of the intervention on lipid profile as measured by high density lipoprotein levels |
| Triglycerides | At 3 months | Effect of the intervention on lipid profile as measured by triglyceride levels |
| Serum vitamin D | At 3 months | Effect of the intervention on serum vitamin D |
| Serum C-reactive protein (CRP) | At 3 months | Effect of the intervention on CRP |
| Maximum oxygen uptake as measured by VO2 max | Baseline | Maximum oxygen uptake as measured by VO2 max |
| Body fat percentage | Baseline | Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis |
| Glycemic control as measured by HbA1c | At 3 months | Glycemic control as measured by HbA1c |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life as measured by NCCN Distress Thermometer | Baseline, 3 months and 6 months | Quality of life as measured by NCCN Distress Thermometer, which measures distress on a scale of 0 to 10, with higher scores indicating worse distress |
| Factors associated with adherence to the program | At 6 months | Factors to be assessed include age, race, time since diagnosis, time since last chemotherapy, medical comorbidities and other lifestyle factors such as alcohol consumption and smoking |
| Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7) | Baseline, 3 months and 6 months | Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report questionnaire measuring anxiety which uses a four-point rating scale (ranging from 0 to 3) asking how often in the last two weeks participants have experienced symptoms pertaining to feeling anxious, worried, difficulty relaxing, and irritability. Higher scores indicate higher distress. with a possible score range of 0 to 21 with higher scores indicating worse anxiety. |
| Quality of life as measured by Brief Pain Inventory (BPI) | Baseline, 3 months and 6 months | Quality of life as measured by Brief Pain Inventory (BPI), a 9-item self-administered questionnaire that can evaluate the effect of an individual's pain on their daily functioning. This is a 10-point scale with 0 being the best possible score, meaning no pain, and 10 being the worst possible score, meaning pain as bad as you can imagine |
| Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9) | Baseline, 3 months and 6 months | Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9), which objectifies degree of depression severity with a possible score range of 0 to 27 and higher scores indicating worse outcomes |
| Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | Baseline, 3 months and 6 months | Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B), a 36-item self-report questionnaire to assess the quality of life as reported by breast cancer survivors with scores ranging from 0 to 123, and lower scores indicating better health. |
Countries
United States
Outcome results
None listed