Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed With Lupron (CRONOS II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,331
- 试验地点
- 50
- 主要终点
- Changes in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36)
研究概览
简要总结
Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed with Lupron.
详细描述
This is a study utilizing a prospective cohort design. Patients with Prostrate cancer (PCa) who are prescribed Lupron will be entered into the study cohort and will be followed for a maximum of 18 months with recommended assessments at 3, 6, 12 and 18 months after Day 1. Treatment of the patients and follow up will be according to the physicians' judgment, regional regulations and the product monograph.
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 99 Years（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •i. Adult ≥ 18 years old
- •ii. Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel.
- •iii. Diagnosed with PCa.
- •iv. Prescribed Lupron as part of his treatment by his treating physician.
排除标准
- •i. Patient cannot or will not sign informed consent.
- •ii. Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of PCa.
- •iii. More than 6 months of therapy if currently on continuous Luteinizing hormone-releasing hormone (LHRH) treatment.
- •iv. If at study enrollment the intent is to only prescribe 1 dose of Lupron (leuprolide acetate)
结局指标
主要结局
Changes in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36)
时间窗: From Month 0 to Month 18
The SF-36 Health is a 36-item general health self-administered questionnaire consisting of 8 scales measuring Physical Function, Physical Role limitations, Vitality, General Health, Pain, Social Function, Emotional Role limitations, and Mental Health.
Change in exercise duration
时间窗: From Month 0 to Month 18
Assessed at every visit what was the amount of various types of exercise performed in the previous month.
Change in dietary habits
时间窗: From Month 0 to Month 18
Assessed at every visit to what extent patient's complied with the Canadian Food Guide's recommendation for each of the four food group servings in the previous week.
次要结局
- Change in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36)(From Month 0 to follow-up visits 3,6 and 12 months)
- Change in weight(From Month 0 to Month 18)
- Change in Body Mass Index (BMI)(From Month 0 to Month 18)
- Caregiver Quality of Life (for patients enrolled under protocol amendment 1)(From Month 0 to Month 18)
- Lupron Cares Patient Support Program(Up to Month 18)
- Changes in the University of California Los Angeles Prostate Cancer Index (UCLA-PI)(From Month 0 to Month 18)
- Changes in the patient's medical condition(From Month 0 to Month 18)
- Proportion of patients with castrate levels of testosterone and undetectable levels of Prostatic Specific Antigen (PSA) at 18 months of treatments.(From Month 0 to Month 18)
- Number of patients with Adverse Events(From Month 0 to Month 18)
- Leuprolide Acetate Utilization(From Month 0 to Month 18)
- Assessment of Financial Burden on Patient's Family (for patients enrolled under protocol amendment 1)(Up to Month 18)
- Changes in the sexual function using the International Index of Erectile Function (IIEF-5)(From Month 0 to Month 18)
- Changes in the Doctor-Patient communication (for patients enrolled prior to protocol amendment 2)(From Month 0 to Month 18)