NCT04000464已完成不适用
Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Reach Recruiting Target
研究概览
简要总结
This study is an investigator initiated clinical study. A prospective, single arm unblinded, open label study will be carried out to determine the feasibility of recruitment, retention and adherence of 30 prostate cancer survivors who have been on androgen deprivation therapy within the last 5 years for a lifestyle modification intervention.
详细描述
Introduction
- Androgen deprivation therapy (ADT) has been demonstrated to improve disease free and over-all survival in men with prostate cancer (PCa).
- ADT for PCa is associated with adverse cardio-metabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction and stroke. This reduces quality of life (QoL) and potentially affects mortality.
- There is paucity of data regarding comprehensive lifestyle interventions in men on ADT for Pca. Existing studies used non-standardized interventions or lack data on metabolic risk factors.
- CLIPP is designed to address these gaps by using an intervention modelled after the Diabetes Prevention Program (DPP), a standardized multi-component intervention with demonstrated effectiveness in reducing diabetes risk factors that has been successfully adapted for multiple disease types including breast cancer.
Intervention:
- 24 Weeks
- Health Coaching Weekly
- Serum & Urine Baseline, Week 12 and Week 24
- Anthropometric Measures
- Questionnaires
- Dual-energy X-ray absorptiometry (DXA) at Baseline and Week 24
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with prostate cancer Stage I, II or IV
- •On androgen deprivation therapy with last 5 years
- •Willing to participate in a lifestyle modification program
- •Willing to modify diet and eating practices
- •Willing to participate in blood collection, urine collection and measurements
- •Minimum of 30 days since participating in another study/trial
- •English speaking
- •40 years of age or older
排除标准
- •Currently participating in another study or trial
- •Currently in hospice
- •Inability to walk two city blocks
- •Inability to comprehend informed consent or procedural requirements
- •Digestive Diseases (IBD, Diverticulitis, etc) that might prevent him from increasing fruit and vegetable intake
结局指标
主要结局
Reach Recruiting Target
时间窗: 6 Months
Recruit 30 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.
Retention of Participants
时间窗: 6 months
80% retention rate, or 24 out of 30 participants
Adherence to Intervention
时间窗: 6 months
75% attendance rate throughout 24 intervention visits
次要结局
- Lipid Panel(6 Months)
- Specific Quality of Life Questionnaire(6 Months)
- Hemoglobin A1c(6 Months)
- Global Quality of Life Questionnaire(6 Months)
- Fasting Glucose(6 Months)
研究者
研究点 (2)
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