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Community Interventions in Non-Medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Harvard - SIP 21-04


Phase 3
45 Years
65 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Community Interventions in Non-Medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Harvard - SIP 21-04


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Outcome Measure:

1.Informed Decision Making

Principal Investigator

Jennifer D Allen, PN MPH ScD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute; Harvard School of Public Health

Authority:

United States: Federal Government

Study ID:

CDC-NCCDPHP-2504

NCT ID:

NCT00207636

Start Date:

December 2004

Completion Date:

September 2007

Related Keywords:

  • Prostate Cancer
  • Computer-Assisted Decision Making
  • Workplace
  • Screening
  • Prostatic Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115