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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized, nutrition and physical activity intervention | Experimental | Initial in-person consult with a registered dietitian, with further in-person follow-ups and monthly telephone consults |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition and physical activity counseling program | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants achieving 10% weight loss | Efficacy of intervention as assessed by percent of participants achieving 10% weight loss | At baseline |
| Percent of participants achieving 10% weight loss | Efficacy of intervention as assessed by percent of participants achieving 10% weight loss | At 3 months |
| Percent of participants achieving 10% weight loss | Efficacy of intervention as assessed by percent of participants achieving 10% weight loss | At 6 months |
| Compliance to the recommended dietary pattern | 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 | At 3 months |
| Compliance to physical activity goal | 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 | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body fat percentage | Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis | Baseline |
| Body fat percentage | Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | 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. | Baseline, 3 months and 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Stone, MD | Cleveland Clinic, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center | Weston | Florida | 33331 | United States |
Will share IPD with other researchers within the same institution, but not outside the institution
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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|
| 3 months |
| Body fat percentage | Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis | 6 months |
| Glycemic control as measured by HbA1c | Glycemic control as measured by HbA1c | At 3 months |
| Glycemic control as measured by HbA1c | Glycemic control as measured by HbA1c | At 6 months |
| Cholesterol | Effect of the intervention on lipid profile as measured by high density cholesterol levels | At 3 months |
| Cholesterol | Effect of the intervention on lipid profile as measured by high density cholesterol levels | At 6 months |
| Low density lipoprotein | Effect of the intervention on lipid profile as measured by low density lipoprotein levels | At 3 months |
| Low density lipoprotein | Effect of the intervention on lipid profile as measured by low density lipoprotein levels | At 6 months |
| high density lipoprotein | Effect of the intervention on lipid profile as measured by high density lipoprotein levels | At 3 months |
| high density lipoprotein | Effect of the intervention on lipid profile as measured by high density lipoprotein levels | At 6 months |
| Triglycerides | Effect of the intervention on lipid profile as measured by triglyceride levels | At 3 months |
| Triglycerides | Effect of the intervention on lipid profile as measured by triglyceride levels | At 6 months |
| Serum vitamin D | Effect of the intervention on serum vitamin D | At 3 months |
| Serum vitamin D | Effect of the intervention on serum vitamin D | At 6 months |
| Serum C-reactive protein (CRP) | Effect of the intervention on CRP | At 3 months |
| Serum C-reactive protein (CRP) | Effect of the intervention on CRP | At 6 months |
| Maximum oxygen uptake as measured by VO2 max | Maximum oxygen uptake as measured by VO2 max | Baseline |
| Maximum oxygen uptake as measured by VO2 max | Maximum oxygen uptake as measured by VO2 max | At 3 months |
| Maximum oxygen uptake as measured by VO2 max | Maximum oxygen uptake as measured by VO2 max | At 6 months |
| Quality of life as measured by Brief Pain Inventory (BPI) | 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" | Baseline, 3 months and 6 months |
| Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7) | 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. | Baseline, 3 months and 6 months |
| Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9) | 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 | Baseline, 3 months and 6 months |
| Quality of life as measured by NCCN Distress Thermometer | 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 | Baseline, 3 months and 6 months |
| Factors associated with adherence to the program | 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 | At 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003710 | Demography |
| D011154 | Population Characteristics |