A Multicenter Study to Evaluate Cardiovascular Risk Factors and Receipt of Primary and Preventive Care in Prostate Cancer Patients Who Receive Definitive Radiation Therapy and Androgen Deprivation Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 8
- 主要终点
- Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
研究概览
简要总结
This study will evaluate the proportion of prostate cancer patients receiving external beam radiation therapy (EBRT) and androgen deprivation therapy (ADT) with controlled blood sugars (fasting glucose and hemoglobin A1c), blood pressure, and cholesterol profile (total cholesterol, LDL, HDL, triglycerides) at baseline, 3 months, and 12 months after completing radiation treatment. In addition, receipt of guideline-recommended cardiovascular, primary and preventive care as well as patient-reported quality of life and satisfaction with care among these patients will be evaluated at baseline and 12 months.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed, non-metastatic prostate cancer
- •Patients who will receive external beam radiation treatment with androgen deprivation therapy (total ADT duration > 3 months) for curative treatment, either in the definitive or post-prostatectomy setting
- •Patients who have a primary care provider
- •Informed consent obtained and signed
- •Ability to read and write English
- •Age >= 18
- •No mental incompetence which would preclude completion of questionnaires
排除标准
- •Prior cancer, pelvic radiation treatment or chemotherapy
- •Patients who do not have a primary care provider
- •Prior ADT
- •Mental incompetence which would preclude completion of questionnaires
- •Unable to read and write English
结局指标
主要结局
Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.
时间窗: Baseline
Blood sugars include fasting glucose and hemoglobin A1c; blood pressure includes systolic and diastolic; and cholesterol profile includes total cholesterol, LDL, HDL, and triglycerides. Baseline is prior to receiving androgen deprivation therapy and prior to radiation.
次要结局
- Patient-reported coordination of care.(12 months post radiation treatment completion)
- Proportion of prostate cancer patients with controlled blood sugars, blood pressure, and cholesterol profile.(12 months post radiation treatment completion)
- Proportion of prostate cancer patients with guideline-recommended cardiovascular preventive care (glucose testing, cholesterol testing, and blood pressure measurement).(12 months post radiation treatment completion)
- Proportion of prostate cancer patients who receive other (non-cardiovascular) guideline-recommended primary and preventive care (flu vaccination, colorectal cancer screening, and healthy lifestyle counseling).(12 months post radiation treatment completion)
- Patient-reported quality of life.(12 months post radiation treatment completion)
- Patient-reported satisfaction with care.(12 months post radiation treatment completion)