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临床试验/NCT00164437
NCT00164437已完成2 期

CD-ROM Intervention for Prostate Cancer Screening

Centers for Disease Control and Prevention2 个研究点 分布在 1 个国家目标入组 554 人开始时间: 2002年9月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
554
试验地点
2
主要终点
decisional conflict,

研究概览

简要总结

The study populations consist of a sample of the patient population (men aged 40-79 years) of a large, group model HMO and a community sample of men age 50-79. Follow-up interviews of men randomly assigned to the intervention and control groups are being conducted by telephone to assess issues related to prostate cancer screening and the men's use of the CD-Rom educational intervention.

详细描述

The study populations consist of a sample of the patient population (men aged 40-79 years) of a large, group model HMO and a community sample of men age 50-79. Follow-up interviews of men randomly assigned to the intervention and control groups are being conducted by telephone to assess issues related to prostate cancer screening and the men's use of the CD-Rom educational intervention. Preliminary results are available for the first 1304 follow-up interviews (interim response rate = 26%). Of 554 men randomized to receive the CD-ROM, 227 (41%) reported receiving the CD-ROM, and 78 (14%) used it in a computer. About 51% of these 78 men used the CD-ROM once only, while 42% used it twice, and 27% shared it with someone else. Most users reported learning some (44%) or a great deal (46%) of new information from the CD-ROM, and most reported that it helped them organize their thoughts about screening somewhat (44%) or a great deal (28%). About 19% indicated that the CD-ROM increased their uncertainty somewhat or a great deal about whether or not they want to be screened, 30% reported that the CD-ROM changed their feelings about whether or not they want to be screened somewhat, and 12% reported that it changed their feelings a great deal. Men who used the CD-ROM had higher education, higher income, higher levels of computer usage, and were more likely to have previously had a PSA test compared to non-users. No other subject characteristics were significantly related to use. Using randomized group assignment in an "intention to treat" analysis, prostate cancer knowledge was significantly higher in the intervention group; there were no differences between study groups in decisional conflict or realistic expectations. However, when comparing those who did and did not use the CD-ROM using multiple regression analysis and controlling for differences in age, race, education, income, insurance status, previous receipt of prostate cancer screening, and computer usage, use of the CD-ROM was significantly associated with higher prostate cancer related knowledge, lower decisional conflict, and more realistic expectations about risk of dying from prostate cancer. After controlling for differences between users and non-users we found evidence that the CD-ROM was effective in reducing decisional conflict, and increasing knowledge and realistic expectations related to prostate cancer screening.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Ect
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

  • 未提供

排除标准

  • prostate cancer

结局指标

主要结局

decisional conflict,

prostate cancer knowledge,

realistic expectations

ability to make an informed decision about prostate cancer screning,

次要结局

  • costs

研究者

研究点 (2)

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