Clinical trial NCT00196807: Prostate Cancer Screening: Fostering Informed Decisions
Official title: Prostate Cancer Screening: Fostering Informed Decisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate cancer screening
medical decision making
informed decision making
patient education
male
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-20
Enrollment: 543
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief 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.

Eligibility 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).

Primary outcomes:
measure: Patient knowledge and decisional satisfaction measured at one month following the intervention.
timeFrame: one-month and one-year follow-up assesments
Secondary outcomes:
measure: Decisional conflict measured at one month and the screening decision measured at one year post intervention.
timeFrame: one-month and one-year follow-up assesments
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Howard University Hospital
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Kathryn L. Taylor, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1093/jnci/djh073. No abstract available.
citation: 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.
citation: Taylor KL, Williams RM, Davis K, Luta G, Penek S, Barry S, Kelly S, Tomko C, Schwartz M, Krist AH, Woolf SH, Fishman MB, Cole C, Miller E. Decision making in prostate cancer screening using decision aids vs usual care: a randomized clinical trial. JAMA Intern Med. 2013 Oct 14;173(18):1704-12. doi: 10.1001/jamainternmed.2013.9253.