Personal Patient Profile - Prostate (P3P) II: Effectiveness-Implementation Trial in Diverse Health Care Networks

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Personal Patient Profile - Prostate (P3P); Behavioral: Standard prostate cancer information websites

• Registration Number: NCT01844999
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

The purpose of this study is to determine whether using the P3P website can increase decisional preparation and satisfaction, and decrease decisional conflict, in men deciding how to manage early stage prostate cancer.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-04-26
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-03
• Study Start: 2013-08-01
• Primary Completion: 2016-06-30
• Study Completion: 2017-06-30
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 392

Inclusion Criteria

• Biopsy-proven diagnosis of prostate cancer, T1 or T2 of any risk level
• Biopsy done at enrolling site
• Upcoming appointment with consulting specialist at enrolling study site
• Able to read, write, understand English

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Exclusion Criteria

• Two or more post-biopsy specialist consults
• Begun treatment (or active surveillance)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual patient education + P3P decision support website	Personal Patient Profile - Prostate (P3P)	-
Usual patient education + standard educational websites	Standard prostate cancer information websites	-

Primary Outcome Measures

Name	Time	Method
Preparation for decision making	1-month after study entry	Graham and O'Connor, 1995, Preparation for decision making scale
Decisional conflict	Change from baseline to 6-months	O'Connor, 1995, Decisional conflict scale
Satisfaction with decision	6-months after study entry	Holmes-Rovner et al, 1996, Satisfaction with decision scale

Secondary Outcome Measures

Name	Time	Method
Concordance of care choice selected with self-reported influential personal preferences	6-months from study entry	Odds ratio of selecting a care option for prostate cancer concordant with avoiding prioritized side effects (XBRT or brachytherapy if concerned with sexual function; prostatectomy if concerned with bowel function; active surveillance if concerned with sexual, bowel, and/or bladder function; any treatment if not concerned with any side effect).
Net cost and benefit of the intervention	1-week after study entry	Cost to the patient will be measured in hours valued according to patient work status, income, and use of time. Benefit will be measured with Willingness to pay.
Time to treatment decision	6-months from study entry	Duration (in days) from pre-decision baseline questionnaire until patient decides on a care option for prostate cancer, either an active treatment type or active surveillance. Measured by patient recall at 6-months.

Trial Locations

Locations (4)

Kaiser Permanente - Souther California; 🇺🇸 Downey, California, United States

Kaiser Permanente - Southern California; 🇺🇸 Los Angeles, California, United States

Emory Healthcare; 🇺🇸 Atlanta, Georgia, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States