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Prostate Cancer Screening: Fostering Informed Decisions

Phase 3
40 Years
70 Years
Not Enrolling
Prostate Cancer

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Trial Information

Prostate Cancer Screening: Fostering Informed Decisions

In spite of the significant disease burden presented by PCa, the utility of screening
asymptomatic men remains controversial, as it has not yet been demonstrated by a randomized
trial that early diagnosis and treatment of PCa reduces disease-related mortality. The
primary goal of the proposed study is neither to encourage nor discourage PCa screening, but
to evaluate a method of patient education that is designed to provide detailed screening and
treatment-related information and to clarify patient preferences and values, ultimately
assisting men in making an informed screening decision. The target population for this
educational intervention will be men who have registered to undergo PCa screening within a
free, mass screening program. Although at first this may appear to be an atypical group to
target for an educational intervention, we present information suggesting that this
population represents a large and uniformed group for whom effective and inexpensive methods
of education are of critical importance. We will test the impact of providing men with
detailed information and a decision aid vs. usual care information and the impact of the
timing of administration of information (a week or more prior to the screening vs. usual
care, which is on the day of screening). Participants will include men who register for the
annual PCa mass screening programs held at Georgetown University and at Howard University
during the 2004 and 2005 screening programs. Following enrollment and the baseline
interview, participants will be randomly assigned to one of four groups: 1) Information plus
Decision Aid received prior to the scheduled screening date (IDA-home); 2) Information plus
Decision Aid received on the day of screening (IDA-clinic); 3) Usual Care information
received prior to the scheduled screening date (UC-home); or 4) Usual Care information
received on the day of the screening (UC-clinic). Follow-up assessments will be conducted
post-screening, post receipt of screening results, and one-year post-intervention, to
measure knowledge, decisional conflict, decisional satisfaction, and the actual screening
decision. We will utilize a 2 (IDA/UC) X 2 (Home/Clinic) X 2 (AA/white) repeated measures
analysis of covariance to assess for group differences on these outcomes. If found to be
effective, the long-term goal of this research program is to disseminate this informational
decision aid for use in mass screening programs.

Inclusion Criteria:

- Inclusion criteria are: 1) 40-70 years old, 2) English-speaking, and 3) ability to
provide meaningful consent.

Exclusion Criteria:

- The exclusion criteria are: 1) a history of cancer (with the exception of basal cell
carcinoma), and 2) a history of prostate disease that has required treatment (e.g.,
benign prostatic hypertrophy).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Patient knowledge and decisional satisfaction measured at one month following the intervention.

Outcome Time Frame:

one-month and one-year follow-up assesments

Safety Issue:


Principal Investigator

Kathryn L. Taylor, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University


United States: Institutional Review Board

Study ID:

R01 CA098967



Start Date:

August 2004

Completion Date:

November 2006

Related Keywords:

  • Prostate Cancer
  • prostate cancer screening
  • medical decision making
  • informed decision making
  • patient education
  • male
  • Prostatic Neoplasms



Howard University Hospital Washington, District of Columbia  20060
Georgetown University Medical Center Washington, District of Columbia  20007