Development of an Aerobic and Resistance Training Feasibility Study for a Racially and Ethnically Diverse Sample of Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,150
- 试验地点
- 3
- 主要终点
- Health Behaviors of Breast Cancer Survivors
研究概览
简要总结
The goal of this behavioral research study is to find out more about the health behaviors of cancer survivors. Researchers want to understand the cultural, social, and environmental factors related to physical activity and personal diet. Researchers also want to learn if cancer survivors who take part in lifestyle interventions have better overall health and quality of life than those who do not take part in these interventions.
详细描述
If you agree to take part in this study, you will have a baseline study visit. This visit will include a physical exam, including measurements of your height and weight. Your hips, wrist, mid-arm, and waist will also be measured. You will also fill out questionnaires that contain items about your diet and exercise habits as well as questions about your quality of life.
Study Groups:
You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
- Group 1 will take part in an exercise intervention program.
- Group 2 will take part in a sedentary behavior and dietary intervention group.
Group 1--Exercise Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-80 years old at diagnosis
- •diagnosed with operable invasive cancer
- •have access to high speed internet
- •Phase 2 only: be currently sedentary (i.e., engage in < or = 60 minutes of purposeful moderate-intensity PA/week)
- •Phase 2 only: be overweight or obese (i.e., have a body mass index (BMI) > or = 25 kg/m^2)
- •speak English
排除标准
- •watch less than 3 hours of television per day
- •be currently enrolled in another intervention study or recently completed a study promoting healthy lifestyle behaviors (diet and/or exercise)
- •participants answering 'Yes' to one or more of the questions on the physical activity readiness questionnaire (PAR-Q) will need to obtain approval from a physician before they can participate in the intervention.
研究组 & 干预措施
Exercise Intervention Program Group
At baseline study visit, participant shown how to complete the physical exercises performed while on study. Pedometer received to track physical activity. Resistance training bands given to use as part of the home-based exercise program. At the baseline study visit, directions received on how to use the study website. Access given to website that will allow tracking of exercise behavior and help set goals. Access given to an internet-based curriculum that will help teach about goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Participant asked to visit website every week. Participant records activity and the number of steps taken every day on the website. Survey completed monthly about attitudes and beliefs about physical activity.
干预措施: Exercise Program (Behavioral)
Exercise Intervention Program Group
At baseline study visit, participant shown how to complete the physical exercises performed while on study. Pedometer received to track physical activity. Resistance training bands given to use as part of the home-based exercise program. At the baseline study visit, directions received on how to use the study website. Access given to website that will allow tracking of exercise behavior and help set goals. Access given to an internet-based curriculum that will help teach about goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Participant asked to visit website every week. Participant records activity and the number of steps taken every day on the website. Survey completed monthly about attitudes and beliefs about physical activity.
干预措施: Website (Behavioral)
Exercise Intervention Program Group
At baseline study visit, participant shown how to complete the physical exercises performed while on study. Pedometer received to track physical activity. Resistance training bands given to use as part of the home-based exercise program. At the baseline study visit, directions received on how to use the study website. Access given to website that will allow tracking of exercise behavior and help set goals. Access given to an internet-based curriculum that will help teach about goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Participant asked to visit website every week. Participant records activity and the number of steps taken every day on the website. Survey completed monthly about attitudes and beliefs about physical activity.
干预措施: Survey (Behavioral)
Sedentary Behavior and Dietary Intervention Group
Access given to internet-based curriculum to help teach about goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Participants read information about improving the quality of their diet and cutting back on sedentary behavior. Participants record on the website how much television watched and how many fruits and vegetables eaten every day. Survey completed monthly about attitudes and beliefs about sedentary behavior and dietary intake.
干预措施: Website (Behavioral)
Sedentary Behavior and Dietary Intervention Group
Access given to internet-based curriculum to help teach about goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Participants read information about improving the quality of their diet and cutting back on sedentary behavior. Participants record on the website how much television watched and how many fruits and vegetables eaten every day. Survey completed monthly about attitudes and beliefs about sedentary behavior and dietary intake.
干预措施: Survey (Behavioral)
Chair-based Study Group
Patients participate in chair-based exercise study. Participants receive chair-based exercise DVD. Chair-based exercise program participation for a total of 8 weeks. Participants receive self-report assessments about quality of life and asked to participate in physical assessments of their balance and coordination.
干预措施: Exercise DVD (Behavioral)
Chair-based Study Group
Patients participate in chair-based exercise study. Participants receive chair-based exercise DVD. Chair-based exercise program participation for a total of 8 weeks. Participants receive self-report assessments about quality of life and asked to participate in physical assessments of their balance and coordination.
干预措施: Self-Report Assessments (Behavioral)
结局指标
主要结局
Health Behaviors of Breast Cancer Survivors
时间窗: 6 months
Data collected from mail-based surveys (n = 1,000) to assess intervention preferences, physical activity (PA), health related quality of life (HRQOL), and mediators of change (e.g., self-efficacy).
次要结局
- Home-Based Exercise Feasibility(6 months)