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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Percent of participants achieving 10% weight loss
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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]
排除标准
- •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.
研究组 & 干预措施
Individualized, nutrition and physical activity intervention
Initial in-person consult with a registered dietitian, with further in-person follow-ups and monthly telephone consults
干预措施: Nutrition and physical activity counseling program (Behavioral)
结局指标
主要结局
Percent of participants achieving 10% weight loss
时间窗: At 6 months
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
Compliance to physical activity goal
时间窗: 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
时间窗: 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
Percent of participants achieving 10% weight loss
时间窗: At baseline
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
Percent of participants achieving 10% weight loss
时间窗: At 3 months
Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
次要结局
- Serum C-reactive protein (CRP)(At 6 months)
- high density lipoprotein(At 6 months)
- Glycemic control as measured by HbA1c(At 6 months)
- Cholesterol(At 6 months)
- Low density lipoprotein(At 6 months)
- Maximum oxygen uptake as measured by VO2 max(At 6 months)
- Serum vitamin D(At 6 months)
- Body fat percentage(6 months)
- Triglycerides(At 6 months)
- Body fat percentage(Baseline)
- Body fat percentage(3 months)
- Glycemic control as measured by HbA1c(At 3 months)
- Cholesterol(At 3 months)
- Low density lipoprotein(At 3 months)
- high density lipoprotein(At 3 months)
- Triglycerides(At 3 months)
- Serum vitamin D(At 3 months)
- Serum C-reactive protein (CRP)(At 3 months)
- Maximum oxygen uptake as measured by VO2 max(Baseline)
- Maximum oxygen uptake as measured by VO2 max(At 3 months)