Telephone Counseling-Mailed Materials Versus Internet Weight Management Interventions in Overweight Cancer Survivors
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
The goal of this behavioral research study is to learn if an internet or phone based exercise and weight management program can help cancer survivors to lose weight and change their eating and exercise behavior.
详细描述
If you agree to take part in this study, you will be asked questions about your physical activity to make sure you are eligible. If you are found to have any pre-existing medical or dietary conditions that may prevent you from participating in this study, you will be asked to have your physician complete a form about your health conditions. You will only be allowed to participate in this study if he or she feels it is safe for you to engage in moderate physical activity. After physician clearance, if applicable, you will be scheduled for study visits at the Behavioral Research and Treatment Center (BRTC) at MD Anderson where you will complete tasks to measure your physical functioning ability. Information about your cancer and treatment history will be collected from your medical records as part of this study.
First Study Visit:
During the week before your first visit to the BRTC, you will complete the following tasks at home:
- You will wear an accelerometer and record your physical activities and exercise in a daily diary. An accelerometer is a small device that you wear on your waist during the day. It records how active you are. The accelerometer and diary will be mailed to you ahead of time, and a study staff member will call you to remind you when to start wearing the accelerometer and recording information in the daily diary.
- You will complete questionnaires that ask about any usual physical activities you may participate in, your health history, your quality of life, your social support, and your confidence for changing your eating and exercise behavior. The questionnaires will be mailed to you with the accelerometer and diary. You will complete the questionnaires at home when you have time. These questionnaires should take you no longer than about 30 minutes total to complete.
- Within a week of your first visit to the BRTC, you will complete 2 online "24-hour diet recalls", 1 during a weekday and the other on a weekend day. One of the diet recalls will be done during your first visit to the BRTC and the other will be done at your home. This involves completing an online questionnaire that asks about what you eat and drink. You will report everything you have consumed in the last 24 hours (from midnight to midnight). A study staff member will call you and tell you when to complete each 24-hour diet recall. Each phone call should last no longer than about 5 minutes, depending on if you have any questions for the study staff member.
You will bring the accelerometer, daily diary, and completed questionnaires with you to your first visit to the BRTC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of either loco-regional breast cancer (Stages 0 - IIIA), colon cancer (Stages I - II), endometrial cancer (Stages I - IIIa) or prostate cancer (Stages I - II);
- •No history of other cancers (excluding non-melanoma skin cancer);
- •Age 18 years of age or older;
- •BMI greater than or equal to 25;
- •Has access to a computer with high-speed internet;
- •Has access to a telephone for possible multiple counseling sessions;
- •Living in the Houston area (Harris county or a contiguous county);
- •Has agreed in the protocol 2009-0544 survey to be re-contacted about studies (for breast, prostate, and colon cancer survivors), or is an endometrial cancer survivor seen seen by an MD Anderson gynecologic oncologist at MD Anderson or an outreach site;
- •Able to come to MD Anderson for assessments at baseline and six-month intervals;
- •Has completed primary cancer treatment and is at least 3 months from surgery (if elected);
- •Able to read and speak English; and
- •Able to provide informed consent.
排除标准
- •Have pre-existing medical conditions that preclude adherence to an unsupervised exercise program or a low-fat, high fruit and vegetable (F&V) diet;
- •Persons using walker or wheelchair/scooter;
- •Women who are pregnant; and
- •Patients that are identified as having metastatic disease at the time of recruitment.
结局指标
主要结局
Recruitment Rate
时间窗: 6 months
Recruitment and drop-out rates in both treatment groups used to assess internal validity of study by comparison of drop-out between two study conditions, and drop-outs to completers.
次要结局
- Drop-Out Rate(6 months)