Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Change in LDL
研究概览
简要总结
The purpose of this study is to learn if lifestyle changes and counseling along with standard medical care, compared to standard medical care alone, can prevent heart problems and diabetes in men who are receiving ADT for prostate cancer treatment.
详细描述
Prostate cancer is a very treatable cancer but those treatments can have long-lasting effects. A kind of hormone therapy called Androgen Deprivation Therapy (ADT) is often used along with other treatments like radiation and has been shown to improve survival. However, ADT can have negative effects especially on the heart and metabolism (the body's system for using and storing energy).
Participation in this study will last for up to 12 months. The study is looking at two different approaches to treating men who are undergoing ADT:
- Staying Strong & Healthy Intervention + Usual Care
- Usual Care
All participants will have blood drawn and be asked questions about how they are feeling during their participation. The men in the Staying Strong & Healthy Intervention group will also take part in a diet and exercise program and receive counseling from a member of the study team.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with prostate cancer
- •Starting or have started ADT (oral or injection) for prostate cancer treatment within the last 3 months
- •Re-initiating ADT after being on holiday for longer than their ADT dosage (e.g. If the man's dosage is every six months and he has been off ADT for more than six he is eligible);
- •Able to speak and read in English or Spanish
- •Reachable consistently by telephone
- •Able to travel to KUMC
排除标准
- •Not diagnosed with prostate cancer
- •Not receiving or planning to receive ADT for prostate cancer treatment within the last three months
- •Initiating ADT for prostate cancer prior to the previous 3 months or are not on ADT holiday
- •Not able to speak and read in English or Spanish
- •Not reachable consistently by telephone
- •Not able to travel to the study site for data collection
结局指标
主要结局
Change in LDL
时间窗: Change from Baseline to Month 12
次要结局
- Change in Body Mass Index (BMI)(Change from Baseline to Month 12)
- Change in Lipid Profile(Change from Baseline to Month 12)
- Change in Health Related Quality(Change from Baseline to Month 12)
- Change in Glucose(Change from Baseline to Month 12)
- Change in Waist/Hip Circumference(Change from Baseline to Month 12)