跳至主要内容
临床试验/NCT03869216
NCT03869216已完成不适用

Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men

Xavier University of Louisiana.2 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2020年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
161
试验地点
2
主要终点
Shared Decision-making

研究概览

简要总结

This behavioral clinical trial assesses the efficacy of a educational intervention to increase shared decision making about prostate-specific antigen (PSA)-based screening for prostate cancer among African American males. Half of participants will receive a multimedia educational intervention, while the other half will receive usual care.

详细描述

The 2018 U.S. Preventive Services Task Force (USPSTF) final recommendation states that male patients and their providers engage in a shared-decision making process about the benefits and harms of PSA-based screening. As characterized by the USPSTF, these conversations are particularly important for African American men given increased ambiguity due to the lack of PSA-based research specific to this population and increased risk of prostate cancer mortality attributed to late stage at diagnosis and more aggressive prostate cancer phenotypes seen in African American men.

The goal of this randomized behavioral clinical trial is to advance the translation path of implementing the decision-making process in clinical encounters by evaluating the efficacy of an educational intervention for African American males to increase shared decision making about PSA-screening versus usual care. The intervention will use multimedia educational training materials to increase understanding of prostate cancer, PSA-based screening, and shared decision making among patients and their primary care providers (PCPs).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Care Provider)

盲法说明

The patients are the unit of randomization and physicians do not know what patients are assigned to the intervention or control arm.

入排标准

年龄范围
40 Years 至 69 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Receiving care at the clinical sites
  • Identify as African American male
  • Ages 40-69 years old

排除标准

  • Personal history of prostate cancer at the time of consent
  • Cognitive impairment that would interfere with participation in the study
  • Unable to complete any aspect of the intervention within the specified time limit

结局指标

主要结局

Shared Decision-making

时间窗: One month after audio-recorded visit

The Observing Patient Involvement (OPTION) Scale was used for the coding of the SDM. The total OPTION scale ranges from 0 to 48. Higher values on the scale mean higher patient involvement in the decision-making process.

次要结局

  • Preference-Congruent Decision Making(Through study completion, an average of 1 year)
  • Quality of Decision (QD)(Up to 24 weeks after the audio-recorded visit)
  • Preference-Congruent Decision Making(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验