Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments personal patient profile - prostate (p3p), standard prostate cancer information websites
Phase phase 3
Sponsor Dana-Farber Cancer Institute
Collaborator National Institute of Nursing Research (NINR)
Start date September 2013
End date June 2016
Trial size 392 participants
Trial identifier NCT01844999, 12-363, 2R01NR009692-05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Other)
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
(Experimental)
personal patient profile - prostate (p3p)
Website supporting informed patient decision making about prostate cancer care through tailored education and coaching

Primary Outcomes

Measure
Decisional conflict
time frame: Change from baseline to 6-months
Preparation for decision making
time frame: 1-month after study entry
Satisfaction with decision
time frame: 6-months after study entry

Secondary Outcomes

Measure
Concordance of care choice selected with self-reported influential personal preferences
time frame: 6-months from study entry
Net cost and benefit of the intervention
time frame: 1-week after study entry
Time to treatment decision
time frame: 6-months from study entry

Eligibility Criteria

Male participants at least 18 years old.

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)

Additional Information

Official title Personal Patient Profile - Prostate (P3P) II: Effectiveness-Implementation Trial in Diverse Health Care Networks
Principal investigator Donna L Berry, PhD, RN
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.