Internet-Based Education for Prostate Cancer Screening
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Prostate cancer (PCa) is the leading cancer diagnosis among men and the second leading cause
      of male cancer death. However, screening asymptomatic men remains controversial, as early
      diagnosis and treatment of PCa has not yet demonstrated reduced disease-related mortality in
      a randomized trial. The goal of the current study is to develop and assess widely accessible
      methods to assist men in making informed decisions about PCa screening. We will compare the
      efficacy of a new web-based, interactive decision support approach to our existing
      print-based PCa screening decision tool, among a diverse sample of male primary care
      patients. Abundant evidence documents the expanding role of the Internet in increasing access
      to and understanding of health information and the need for systematic evaluations of
      Internet-based interventions. A novel aspect of the proposed trial will be our focus on
      cognitive biases as a factor that has limited the success of previous information-based
      interventions. Specifically, we will evaluate: 1) confirmation bias and 2) short-term
      consequences bias.
    

Detailed description: 
      In Phase I (months 1-8) of this five-year project, we will develop an interactive,
      Internet-based, patient information and decision aid. In Phase II (months 9-60), we will
      evaluate the impact of this decision aid in a randomized controlled trial with male primary
      care patients aged 45-70 from three Washington, District of Columbia area health care
      settings (N = 1875). Trial arms include: 1) print-based information and decision aid (Print),
      2) web-based information plus interactive decision aid (Web), and 3) usual care (UC).
      Subjects will complete outcome assessments at baseline, one- and 13-months post-baseline. The
      specific aims are to: 1. Evaluate the impact of the delivery method (Web vs. Print vs. Usual
      Care) on the key patient outcome variables of knowledge, decisional satisfaction, and the
      screening decision. 2. Identify factors that moderate the interventions' impact on the
      primary outcomes. 3. Identify the mechanisms by which the interventions impact knowledge and
      decisional satisfaction. In exploratory analyses, we will evaluate factors that are related
      to use of the web and print materials. This research has the potential to make several
      significant and innovative contributions: 1) the development and evaluation of a widely
      accessible method of educating a heterogeneous group of patients about a controversial topic,
      which can be adapted for other similarly contentious issues, 2) a determination of whether
      Web based materials are a feasible method of patient education for this age cohort, compared
      to print materials, 3) an understanding of cognitive factors that may hinder comprehension of
      a controversial medical decision, 4) a determination of who among the target population
      benefits the most from a web-based intervention, and 5) the information required to
      streamline and target future web-based educational interventions.
    

Intervention name(s): educational internet site on prostate cancer screening; Educational print booklet; Usual care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Healthy men between 45-70 receive the login information to access our educational internet site on prostate cancer screening.; Healthy men between 45-70 receive a copy of our educational print booklet in the mail.; Healthy men aged 45-70 receive no intervention and are followed for one year, along with the men in the two intervention arms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: prostate cancer screening education; behavioral oncology; randomized trial