Prostate Cancer Screening: Fostering Informed Decisions
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary goal of this study is to develop and evaluate a print-based method of patient
      education with a decision tool that is designed to provide detailed information about
      prostate cancer and to clarify patient preferences and values, ultimately assisting men in
      making an informed screening decision.
    

Detailed description: 
      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.
    

Intervention name(s): patient decision aid (print-based)
Intervention type(s): Behavioral
Intervention description(s): To evaluate the impact of the decision aid intervention (information plus decision aid (IDA) vs. usual care (UC)), and timing of intervention delivery (at Home (pre-screening) vs. in the Clinic (screening day)) on key patient outcome variables of PCa knowledge and decisional satisfaction.
Other intervention name(s): Information plus Decision Aid at home; Information plus Decision Aid at clinic; Usual Care at home; Usual Care at clinic
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: prostate cancer screening; medical decision making; informed decision making; patient education; male