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

January 30, 2018 updated by: Donna Berry, PhD, RN, FAAN, ACON, Dana-Farber Cancer Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

392

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Downey, California, United States
        • Kaiser Permanente - Souther California
      • Los Angeles, California, United States
        • Kaiser Permanente - Southern California
    • Georgia
      • Atlanta, Georgia, United States
        • Emory Healthcare
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual patient education + standard educational websites
Behavioral: 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: Usual patient education + P3P decision support website
Behavioral: Personal Patient Profile - Prostate (P3P)
Website supporting informed patient decision making about prostate cancer care through tailored education and coaching

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Donna L Berry, PhD, RN, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

April 26, 2013

First Submitted That Met QC Criteria

May 1, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-363
  • 2R01NR009692-05 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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