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Completed

NCT Number: NCT00692653

Personal Patient Profile Prostate (P4) Randomized, Multisite Trial

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center / Medical College of Georgia, Augusta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

P4

Behavioral

Tailored online decision support system for prostate cancer treatment decision making

Primary outcomes

  1. Decisional Conflict

    Time frame: Baseline to 6 months

  2. Decisional Satisfaction

    Time frame: Baseline to 6 months

  3. Satisfaction with Preparation for Decision Making

    Time frame: Baseline to 1 month

Secondary outcomes

  1. Shift in decisional control preference from pre-decision to 1 month post-treatment

    Time frame: Baseline to 1 month

  2. Resource utilization

    Time frame: Baseline to 6 months

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • University of Washington

Registry information

Acronym: P4

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 6, 2008
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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