Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Harvard - SIP 21-04
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 812
- Locations
- 2
- Primary Endpoint
- Percentage of Patients Who Were Ready to Make a Decision or Were Undecided
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Worksites employing at least 100 men in target age group (45-65 years old)
Exclusion Criteria
- •Worksites with high turnover
- •Non-English speaking workers
- •Temporary or contract workers
Arms & Interventions
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.
Intervention: Computer Assisted Decision making tool (Behavioral)
Outcomes
Primary Outcomes
Percentage of Patients Who Were Ready to Make a Decision or Were Undecided
Time Frame: 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.
Time Frame: 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.
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)