NCT00630188

Brief Summary

The purpose of this study is to determine whether an intervention designed to help men share decisions about prostate cancer screening with their physician results in better decision making, more shared decisions, and changes in intended and actual screening rates.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
Last Updated

March 6, 2008

Status Verified

February 1, 2008

Enrollment Period

1.1 years

First QC Date

February 28, 2008

Last Update Submit

March 5, 2008

Conditions

Prostatic Neoplasms

Keywords

prostate cancer screeningshared decision makingprostate-specific antigendecision makingphysician-patient relations

Outcome Measures

Primary Outcomes (3)

  • Men's understanding that prostate cancer screening requires a decision

    baseline, post intervention, post clinical visit

  • Men's knowledge about prostate cancer and prostate cancer screening

    baseline, post intervention, post clinical visit

  • Men's participation in the decision about prostate cancer screening with their clinician at their preferred level

    baseline, post intervention, post clinical visit

Secondary Outcomes (4)

  • The presence of a shared decision

    post clinical visit

  • men's intent to be screened for prostate cancer

    post clinical visit

  • Self reported screening

    post visit

  • Actual screening by chart review

    9 month follow-up

Study Arms (2)

1

EXPERIMENTAL

For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with physician For Physicians: a one-time educational session on prostate cancer and the value of shared decision making

Other: You Decide

2

ACTIVE COMPARATOR

Highway Safety video

Other: Reducing Your Risks in the Crash

Interventions

You DecideOTHER

For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with clinician For Physicians: a one-time educational session on prostate cancer and the value of shared decision making

1
Reducing Your Risks in the CrashOTHER

Publicly available video on highway safety and reducing individual risks in a crash

2

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 40-80 years
  • Their physician agreed to participate in the study
  • Seen in practice for at least one year

You may not qualify if:

  • Prior history of prostate cancer
  • Presenting for acute medical visit
  • Non-skin cancer
  • Lung disease requiring oxygen
  • Renal failure requiring dialysis
  • Intensive care visit in last 6 months
  • Need assistance with activities of daily living

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chapel Hill North General Internal Medicine Practice

Chapel Hill, North Carolina, 27516, United States

Location

University of North Carolina at Chapel Hill General Medicine Clinic

Chapel Hill, North Carolina, 27599, United States

Location

Moses Cone Internal Medicine Practice

Greensboro, North Carolina, 27401, United States

Location

Triad Internal Medicine

Greensboro, North Carolina, 27405, United States

Location

Related Publications (1)

  • Sheridan SL, Golin C, Bunton A, Lykes JB, Schwartz B, McCormack L, Driscoll D, Bangdiwala SI, Harris RP. Shared decision making for prostate cancer screening: the results of a combined analysis of two practice-based randomized controlled trials. BMC Med Inform Decis Mak. 2012 Nov 13;12:130. doi: 10.1186/1472-6947-12-130.

    PMID: 23148458DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Russ Harris, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Lauren McCormack, PhD, MSPH

    RTI International

    PRINCIPAL INVESTIGATOR

  • David Driscoll, PhD, MSPH

    RTI International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 6, 2008

Study Start

March 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

March 6, 2008

Record last verified: 2008-02

Locations

US(4)