Prostate Cancer Screening: Fostering Informed Decisions

NCT ID: NCT00196807

Last Updated: 2010-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 543 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2006-11-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Information plus DA at home

Group Type: EXPERIMENTAL

patient decision aid (print-based)

Intervention Type: BEHAVIORAL

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.

UC Information at home

Group Type: ACTIVE_COMPARATOR

patient decision aid (print-based)

Intervention Type: BEHAVIORAL

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.

Information plus decision aid at clinic

Group Type: EXPERIMENTAL

patient decision aid (print-based)

Intervention Type: BEHAVIORAL

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.

UC Information at clinic

Group Type: ACTIVE_COMPARATOR

patient decision aid (print-based)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Information plus Decision Aid at home; Information plus Decision Aid at clinic; Usual Care at home; Usual Care at clinic

Eligibility Criteria

Inclusion 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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Georgetown University Medical Center

Principal Investigators

Kathryn L. Taylor, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Howard University Hospital

Washington D.C., District of Columbia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 14996868 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20578178 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23896732 (View on PubMed)

Other Identifiers

R01CA098967

Identifier Type: NIH

Identifier Source: secondary_id

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R01CA098967

Identifier Type: NIH

Identifier Source: org_study_id

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