Prostate Cancer Screening: Fostering Informed Decisions

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00196807
First received: September 12, 2005
Last updated: January 19, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Behavioral: patient decision aid (print-based)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Prostate Cancer Screening: Fostering Informed Decisions

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Patient knowledge and decisional satisfaction measured at one month following the intervention. [ Time Frame: one-month and one-year follow-up assesments ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decisional conflict measured at one month and the screening decision measured at one year post intervention. [ Time Frame: one-month and one-year follow-up assesments ] [ Designated as safety issue: No ]

Enrollment: 543
Study Start Date: August 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Information plus DA at home Behavioral: patient decision aid (print-based)
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 Names:
  • Information plus Decision Aid at home
  • Information plus Decision Aid at clinic
  • Usual Care at home
  • Usual Care at clinic
Active Comparator: UC Information at home Behavioral: patient decision aid (print-based)
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 Names:
  • Information plus Decision Aid at home
  • Information plus Decision Aid at clinic
  • Usual Care at home
  • Usual Care at clinic
Experimental: Information plus decision aid at clinic Behavioral: patient decision aid (print-based)
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 Names:
  • Information plus Decision Aid at home
  • Information plus Decision Aid at clinic
  • Usual Care at home
  • Usual Care at clinic
Active Comparator: UC Information at clinic Behavioral: patient decision aid (print-based)
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 Names:
  • Information plus Decision Aid at home
  • Information plus Decision Aid at clinic
  • Usual Care at home
  • Usual Care at clinic

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196807

Locations
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Howard University Hospital
Washington, District of Columbia, United States, 20060
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Kathryn L. Taylor, Ph.D. Georgetown University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kathryn L. Taylor, PhD, Principal Investigator, Georgetown University Medical Center
ClinicalTrials.gov Identifier: NCT00196807     History of Changes
Other Study ID Numbers: R01 CA098967, R01CA098967
Study First Received: September 12, 2005
Last Updated: January 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
prostate cancer screening
medical decision making
informed decision making
patient education
male

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 22, 2014