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Prostate Cancer Screening: Fostering Informed Decisions

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
patient decision aid (print-based)
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer focused on measuring prostate cancer screening, medical decision making, informed decision making, patient education, male

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Georgetown University Medical Center
  • Howard University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Information plus DA at home

UC Information at home

Information plus decision aid at clinic

UC Information at clinic

Arm Description

Outcomes

Primary Outcome Measures

Patient knowledge and decisional satisfaction measured at one month following the intervention.

Secondary Outcome Measures

Decisional conflict measured at one month and the screening decision measured at one year post intervention.

Full Information

First Posted
September 12, 2005
Last Updated
January 19, 2010
Sponsor
Georgetown University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00196807
Brief Title
Prostate Cancer Screening: Fostering Informed Decisions
Official Title
Prostate Cancer Screening: Fostering Informed Decisions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Georgetown University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer screening, medical decision making, informed decision making, patient education, male

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
543 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Information plus DA at home
Arm Type
Experimental
Arm Title
UC Information at home
Arm Type
Active Comparator
Arm Title
Information plus decision aid at clinic
Arm Type
Experimental
Arm Title
UC Information at clinic
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
patient decision aid (print-based)
Other Intervention Name(s)
Information plus Decision Aid at home, Information plus Decision Aid at clinic, Usual Care at home, Usual Care at clinic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient knowledge and decisional satisfaction measured at one month following the intervention.
Time Frame
one-month and one-year follow-up assesments
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn L. Taylor, Ph.D.
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14996868
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.
Results Reference
background
PubMed Identifier
20578178
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.
Results Reference
result
PubMed Identifier
23896732
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.
Results Reference
derived

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Prostate Cancer Screening: Fostering Informed Decisions

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