NCT03820024已完成不适用
The MOVES Trial: MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention
研究概览
简要总结
Overweight and obese endometrial cancer (EC) survivors at the University of North Carolina (UNC) at Chapel Hill will be approached for tailored feedback fitness intervention. The investigators plan to enroll 36 women (18 in each arm) to evaluate if receipt of weekly tailored feedback messages can improve physical activity in EC survivors. It is hypothesized that women receiving the feedback message intervention will increase step counts from baseline more than 2,000 steps compared to women in the non-intervention arm.
详细描述
Objectives:
- To assess if a tailored feedback fitness intervention can increase physical activity in EC survivors from baseline to 12 weeks post-baseline
- To determine the acceptability of the fitness intervention in EC survivors through a completion survey.
- To assess if a tailored feedback message fitness intervention can (1) decrease BMI, (2) reduce waitst to hip (W.H) ratios, (3) improve quality of life (QOL) and (4) improve serum metabolic markers (insulin, glucose and low density lipoprotein (LDL) in EC survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- •Be over the age of 18 years
- •Have a confirmed diagnosis of endometrial cancer and have completed therapy (surgery, chemotherapy or radiation) within the past 6 months
- •Have no current evidence of endometrial cancer
- •Have a BMI 25 kg/m2 or greater
- •Have approval from their treating physician to engage in moderate-intensity physical activity.
- •Have a smart phone with Bluetooth capabilities turned on
- •Have access to email
排除标准
- •Are currently undergoing treatment for their cancer
- •Are unable to read a sample message aloud
- •Do not have a computer or smart phone with Bluetooth capabilities
- •Are pregnant
- •Have a history of angina or palpitations with exertion
- •Have a history of uncontrolled pulmonary disease (COPD or asthma)
- •Have one or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.
结局指标
主要结局
Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention
时间窗: 13 weeks
Steps recorded on a fitness tracker at week 1 and week 13
次要结局
未报告次要终点
研究者
研究点 (2)
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