Healthy New Albany: Breast Cancer Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Mobility disability
研究概览
简要总结
This trial studies the benefits of an exercise and diet counseling program in improving quality of life in stage I-III breast cancer survivors. Exercise and diet counseling may help improve weight loss and relevant clinical and patient-reported outcomes in overweight or obese breast cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of delivering a community-based, comprehensive lifestyle weight management (LWM) intervention to 20 overweight or obese breast cancer (BC) survivors.
II. Explore preliminary efficacy of the community-based, comprehensive LWM intervention for producing meaningful improvements in select clinically-relevant anthropometric, fitness, functional, and patient-reported outcomes in BC survivors.
III. Provide the effect size estimates necessary to inform the design of a subsequent R01 application addressing a large scale, optimally powered, randomized controlled, community-based LWM comparative efficacy intervention trial targeting weight loss in BC survivors.
OUTLINE:
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female breast cancer (stage I-III), within (w/in) 60 months after cessation of active treatment (surgery, chemotherapy, radiation), and may be on continued hormone therapy.
- •Overweight/obese (body mass index [BMI] > 25).
- •Ability to understand and the willingness to sign a written informed consent.
- •Willing and physically able to participate in physical activity.
- •Obtain physician consent via primary care physician and/or treating oncologist.
排除标准
- •> 60 months post breast cancer therapy.
- •Contraindications to exercise.
- •Diagnosis of cancer other than breast that is receiving active treatment.
- •Currently receiving chemotherapy/radiation.
- •Musculoskeletal/neurological disorder inhibiting them from safe exercise.
- •Pregnant or nursing women.
- •Unable to give informed consent.
结局指标
主要结局
Mobility disability
时间窗: Baseline up to 6 months
Assessed with the 400-meter walk test. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =\< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the last observation carried forward (LOCF) approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
次要结局
- Self-reported physical function(Baseline up to 6 months)
- Muscular strength assessement(Baseline up to 6 months)
- Body composition(Baseline up to 6 months)
- Objective functional performance(Baseline up to 6 months)
- Quality of life (QOL) survey using the Functional Assessment of Cancer Therapy- breast (FACT-B).(Baseline up to 6 months)
- Body weight(Baseline up to 6 months)
- Brief Fatigue Inventory (BFI)(Baseline up to 6 months)
- Balance deficits assessment(Baseline up to 6 months)
- Quality of life (QOL) surveys using the Rand Short Form Health Survey (SF-12)(Baseline up to 6 months)
- Adherence assessment(Up to 6 months)
- Feasibility measures(Up to 24 weeks)
研究者
Brian Focht
Principal Investigator
Ohio State University Comprehensive Cancer Center