Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Harvard - SIP 21-04
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 812
- 试验地点
- 1
- 主要终点
- Percentage of Patients Who Were Ready to Make a Decision or Were Undecided
研究概览
简要总结
The purpose of this study is to develop and evaluate a computer-based decision aid (DA) for use by men considering prostate-specific antigen (PSA) screening for prostate cancer. Major medical organizations recommend that men discuss the risks and benefits of this test with their physician before making the decision. This educational, interactive DA will help them prepare for that discussion.
详细描述
Prostate cancer (CaP) is a formidable public health problem in the US and in industrialized countries worldwide. Methods for primary prevention of CaP are unknown. As a result, early detection has become a mainstay of cancer control efforts. However, there is considerable controversy regarding the efficacy of screening in reducing disease-specific mortality. In light of this uncertainty, major medical organizations, including the National Cancer Institute, currently recommend that men discuss the pros and cons of CaP screening and make individualized screening decisions with their health care providers. However, because of constraints on time during medical encounters, it is not always feasible for providers to engage in in-depth discussions regarding the complexities of this issue. Therefore, interventions to promote informed decision-making (IDM) outside of clinical settings are needed.
In this study, we propose to: (1) develop an interactive computer-based decision aid (DA) to promote IDM for CaP screening; and (2) conduct a randomized controlled worksite trial to evaluate the impact the DA intervention on employed men's ability to make informed decisions regarding CaP. This work is designed to be responsive to recent calls for IDM interventions in community settings among diverse populations. If successful, our findings could validate the effectiveness of DAs to promote IDM for CaP and serve as a model for widespread dissemination, thus improving quality of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Worksites employing at least 100 men in target age group (45-65 years old)
排除标准
- •Worksites with high turnover
- •Non-English speaking workers
- •Temporary or contract workers
研究组 & 干预措施
Control
Distribution of printed materials
Computer Assisted Decision making tool
The intervention consisted of access to a computer tailored decision aid designed to promote informed decision making.
干预措施: Computer Assisted Decision making tool (Behavioral)
结局指标
主要结局
Percentage of Patients Who Were Ready to Make a Decision or Were Undecided
时间窗: Assessed at baseline and follow-up, up to 10 months
Readiness to make a decision based on Stage of Decision-Making Scale (O'Connor A et al, 2008) with five responses ranging from "I haven't thought about it before" to "I have made a decision, and I am not likely to change my mind." Men were classified as having "decided" if they stated either that they had made a decision, but were willing to reconsider, or if they responded that they had made a decision but were unlikely to change their mind. Those "undecided" reported that they had not thought about the decision, or were uncertain.
Percentage of Correct Responses in Assessing Mens' Recognition of the Prostate-specific Antigen Test and Knowledge Related to Prostate-cancer Topics.
时间窗: Assessed at baseline and follow-up, up to 10 months
Recognition of test based upon a standard single item and 14 validated questions assessed knowledge of prostate cancer prevalence, risk factors, screening modalities, diagnostic procedures, and treatment-related complications.
Mean and Standard Error of a Scale Used to Assess Men's Confidence Level in Making Decisions Related to Prostate Cancer Screening.
时间窗: Assessed at baseline and follow-up, up to 10 months
The confidence in ability to participate in decision making to the extent desired using the 11-item Decision Self-Efficacy Scale was assessed. Respondents were asked to reflect on their confidence level about various aspects of the decision-making process, with response options of "very confident" (score = 4) to "not at all confident" (score = 0). Scores were summed, divided by 11, and multiplied by 25, to arrive at a range of scores from 0 (no self-efficacy) to 100 (higher self-efficacy).
Percentage of Consistency Between Screening Preference and Personal Values Relevant to the Screening Decision
时间窗: Assessed at baseline and follow-up, up to 10 months
Items were developed to assess the personal importance or relative worth of the advantages and limitations of screening based on focus group themes and published literature. Some to the themes include: importance of information, accuracy of test, potential side effects of treatment.
次要结局
- Percentage of Men Who Have Active Decision-making, Collaborative Decision-making, or Passive Decision-making Styles(Assessed at baseline and follow-up, up to 10 months)
- Mean and Standard Error of a Scale to Measure Decisional Conflict(Assessed at baseline and follow-up, up to 10 months)