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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844999
• Other study ID #: 12-363
• Secondary ID: 2R01NR009692-05
• Status: Completed
• Phase: N/A
• First received: April 26, 2013
• Last updated: January 30, 2018
• Start date: August 1, 2013
• Est. completion date: June 30, 2017

Study information

• Verified date: January 2018
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Two or more post-biopsy specialist consults

• Begun treatment (or active surveillance)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Personal Patient Profile - Prostate (P3P)
Website supporting informed patient decision making about prostate cancer care through tailored education and coaching
• Standard prostate cancer information websites
Standard prostate cancer information websites (e.g., NCI, ASCO) presented to patients in addition to patient education that is usual in their clinics

Locations

Country	Name	City	State
United States	Emory Healthcare	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Kaiser Permanente - Souther California	Downey	California
United States	Kaiser Permanente - Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict	O'Connor, 1995, Decisional conflict scale	Change from baseline to 6-months
Primary	Preparation for decision making	Graham and O'Connor, 1995, Preparation for decision making scale	1-month after study entry
Primary	Satisfaction with decision	Holmes-Rovner et al, 1996, Satisfaction with decision scale	6-months after study entry
Secondary	Concordance of care choice selected with self-reported influential personal preferences	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).	6-months from study entry
Secondary	Net cost and benefit of the intervention	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.	1-week after study entry
Secondary	Time to treatment decision	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.	6-months from study entry