Clinical trial NCT00207636: Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening
Official title: Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Harvard - SIP 21-04
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Computer-Assisted Decision Making
Workplace
Screening
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Dana-Farber Cancer Institute
First posted: 2005-09-21
Enrollment: 812
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients Who Were Ready to Make a Decision or Were Undecided
timeFrame: Assessed at baseline and follow-up, up to 10 months
measure: Percentage of Correct Responses in Assessing Mens' Recognition of the Prostate-specific Antigen Test and Knowledge Related to Prostate-cancer Topics.
timeFrame: Assessed at baseline and follow-up, up to 10 months
measure: Mean and Standard Error of a Scale Used to Assess Men's Confidence Level in Making Decisions Related to Prostate Cancer Screening.
timeFrame: Assessed at baseline and follow-up, up to 10 months
measure: Percentage of Consistency Between Screening Preference and Personal Values Relevant to the Screening Decision
timeFrame: Assessed at baseline and follow-up, up to 10 months
Secondary outcomes:
measure: Percentage of Men Who Have Active Decision-making, Collaborative Decision-making, or Passive Decision-making Styles
timeFrame: Assessed at baseline and follow-up, up to 10 months
measure: Mean and Standard Error of a Scale to Measure Decisional Conflict
timeFrame: Assessed at baseline and follow-up, up to 10 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute; Harvard School of Public Health
name: Jennifer D Allen, PN MPH ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen JD, Othus MK, Hart A Jr, Tom L, Li Y, Berry D, Bowen D. A randomized trial of a computer-tailored decision aid to improve prostate cancer screening decisions: results from the Take the Wheel trial. Cancer Epidemiol Biomarkers Prev. 2010 Sep;19(9):2172-86. doi: 10.1158/1055-9965.EPI-09-0410. Epub 2010 Aug 17.