Prostate Cancer Screening: Fostering Informed Decisions

Prostate Cancer Clinical Trial

Official title:

Prostate Cancer Screening: Fostering Informed Decisions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196807
• Other study ID #: R01CA098967
• Secondary ID: R01CA098967
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 19, 2010
• Start date: August 2004
• Est. completion date: November 2006

Study information

• Verified date: January 2010
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 543
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Howard University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Red SN, Kassan EC, Williams RM, Penek S, Lynch J, Ahaghotu C, Taylor KL. Underuse of colorectal cancer screening among men screened for prostate cancer: a teachable moment? Cancer. 2010 Oct 15;116(20):4703-10. doi: 10.1002/cncr.25229. — View Citation

Taylor KL, Africano NL, Schwartz M, Cullen J, Ahaghotu C. Prostate cancer screening at National Cancer Institute comprehensive and clinical cancer centers. J Natl Cancer Inst. 2004 Mar 3;96(5):414-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient knowledge and decisional satisfaction measured at one month following the intervention.		one-month and one-year follow-up assesments	No
Secondary	Decisional conflict measured at one month and the screening decision measured at one year post intervention.		one-month and one-year follow-up assesments	No