Personal Patient Profile Prostate (P4) Randomized, Multisite Trial

Dana-Farber Cancer Institute

Status: Completed

Conditions: Prostate Cancer

Treatments: Behavioral: P4

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00692653

1R01NR009692

R01NR009692 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine whether or not participation in an experimental program called the "P4 program" is useful to men who are faced with choices about treatment for their early stage prostate cancer. The P4 program consists of a series of questions and information for the participant.

Before seeing the cancer specialist, participants will answer several questionnaires on a computer. This will take about 20-30 minutes. Participants may choose to do this on a computer at home or on a touch-screen computer in the clinic. Half the participants will then be shown several highly rated informational websites about prostate cancer treatments. The other half, based on the individual participant's answers, will receive the P4 program's customized written and on-screen information. Reading the information and watching videos will take about 20 minutes.

About one month later, and again 6 months, participants will complete follow-up questionnaires electronically or by mail. These questionnaires will help us understand how each participant's decision for treatment of their prostate cancer went. Answering these questionnaires should take about 20 minutes each time.

Enrollment: 498 patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy-proven diagnosis of prostate cancer, stage I or II
• Diagnosis within the past 6 months
• Has appointment with a consulting specialist at one of the clinical trial sites
• Must be able to read and write English or Spanish at a 6th grade level
• Must not have begun any treatment (except watchful waiting)
• Must be able to complete baseline assessment before target clinician visit.

Exclusion criteria

• Advanced prostate cancer
• Diagnosed more than 6 months ago
• Cannot read and write English or Spanish at a 6th grade level
• Does not have appointment at one of the clinical trial sites

Trial design

498 participants in 2 patient groups

P4

Experimental group

Description:

Participant uses P4 program before meeting with his clinician to discuss treatment options.

Treatment:

Behavioral: P4

Usual care+

No Intervention group

Description:

Usual care plus participant is directed to reputable websites highly rated in research literature to learn more about prostate cancer treatments.