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临床试验/NCT01244568
NCT01244568已完成不适用

Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment- Study 2

University of North Carolina, Chapel Hill4 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
218
试验地点
4
主要终点
Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months

研究概览

简要总结

Researchers in this study will determine whether providing decision support interventions (DESIs) to men with low risk prostate cancer improves their decision-specific knowledge and alters their treatment decisions.

详细描述

Potentially eligible men (age 45 and older who have localized prostate cancer with a Gleason score of 6 or less) will be identified and recruited to participate in the study before their next office visit. Patients who are interested and provide informed consent will be asked to complete a brief survey about background, medical history, knowledge of prostate cancer and health-related quality of life. Once the survey is completed the patient will be randomly assigned to one of 2 groups. Those assigned to the "Usual Care" group will not receive any additional information materials as part of their participation in the study. Those assigned to the "Patient Decision Support" group will receive a DVD program that contains information about treatment choices for prostate cancer.

Participants will be asked to answer a brief telephone survey at 3 and 6 months from the day of their last office visit. Survey questions will ask about knowledge about prostate cancer, health-related quality of life, whether or not the DVD was viewed and what treatment decision was made.

Research staff will also review medical records 6 months after enrollment to determine which treatment was received for prostate cancer, how many visits with health care providers were completed since enrollment and which medical services and procedures were received.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age 45 or older Localized prostate cancer with a Gleason score of 6 or less

排除标准

  • 未提供

结局指标

主要结局

Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months

时间窗: 3 and 6 month follow-up

Men who review a DESI before making a treatment decision will be more likely to choose active surveillance/watchful waiting and will have better decision-specific knowledge.

次要结局

  • DESI viewing(3 month follow-up (phone survey))
  • Healthcare utilization(6 month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carmen Lewis, MD, MPH

Associate Professor

University of North Carolina, Chapel Hill

研究点 (4)

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