Testing the Helpfulness of 2 Decision Aids for Prostate Cancer

March 7, 2016 updated by: VA Office of Research and Development

Impact of a Plain Language Prostate Cancer Decision Aid on Decision Making

The purpose of this study is to test different methods for communicating information about prostate cancer treatment to men. The investigators are studying how best to present information so men can make informed decisions about what prostate cancer treatment to undergo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background/Rationale: Prostate cancer is the second leading cause of cancer related death among men in the United States, and accounts for 29% of all cancers diagnosed in men. Furthermore, approximately one in six men will be diagnosed with prostate cancer in their lifetime. Thus, 17% of male Veterans will be asked to make a decision about the treatment of their prostate cancer. The burden of this disease is further magnified when one considers that most patients will live for years following their diagnosis and with any adverse effects of therapy. Given that there have been no clinical trials showing that any prostate cancer treatment produces an increased likelihood of survival; men are asked to actively participate in treatment decisions. Previous research has revealed that men are often uninformed about their prostate cancer, particularly African American men and men with lower educational attainment. Thus, it is critical to develop and test decision aids that can help all men (especially men with low literacy skills) make an informed decision.

Objective(s): The goal of the study is to compare the impact of a plain language decision aid (DA) to a conventional DA on prostate cancer patients' decision making experience and communication with their physician.

Methods: This study is a randomized controlled trial. Men undergoing a prostate biopsy will be recruited at the time of biopsy and complete a baseline interview (at pre-biopsy or biopsy appointment). Those patients diagnosed with localized prostate cancer will complete two additional interviews: at physician visit (diagnosis), and 7-10 days following physician visit (phone survey). The treatment discussion between patients and their physician will be audio recorded.

Major characteristics: All men, without a prior history of prostate cancer, undergoing a prostate biopsy will be screened for eligibility and enrolled by the study coordinator. Additional inclusion criteria include ability to speak English, provide informed consent, and have a PSA < 20. Physicians can refuse to allow a patient participate in the study at the time of biopsy. Men will be recruited from 4 VA hospitals (Ann Arbor, Durham, Pittsburgh, and San Francisco) and randomized to receive one of two decision aid booklets (plain language vs. conventional).

Major variables and source(s) of data: All survey data will be collected from either face-to-face or phone interviews. The surveys include measures of literacy, numeracy, anxiety, preference for shared decision making, knowledge, treatment preferences, risk perceptions, perception of patient-physician communication, and confidence and satisfaction with the decision making process. All survey questions were read aloud and responses recorded.

Status: Recruitment began in September 2008 and concluded in May of 2012.

1552 men were approached to participate in the study with 1028 agreeing. 1023 completed the Time 1 interview. Of the 334 subjects eligible to continue with study activities, 285 subjects completed the Time 2 interview (biopsy results visit), and 244 completed the Time 3 phone interview.

Study Type

Interventional

Enrollment (Actual)

1028

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
      • San Francisco, California, United States, 94121
        • VA Medical Center, San Francisco
    • Michigan
      • Ann Arbor, Michigan, United States, 48113-0170
        • VA Ann Arbor Healthcare System
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • VA Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • Center for Health Equity Research and Promotion

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Men undergoing a prostate cancer biopsy at Ann Arbor, Durham, San Francisco, or Pittsburgh VAs. Additional inclusion criteria includes ability to speak English, provide informed consent, and have a PSA < 20.

Exclusion Criteria:

Prior history of prostate cancer

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Patients will receive Michigan Cancer Consortium decision aid.
Behavioral: type of decision aid
We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.
ACTIVE_COMPARATOR: Arm 2
Patients will receive National Comprehensive Cancer Network decision aid.
Behavioral: type of decision aid
We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge
Time Frame: Results visit (Time 2 - approximately 7-10 days after Time 1)
Questions addressed the survival benefit and side effects associated with treatment options for localized prostate cancer.
Results visit (Time 2 - approximately 7-10 days after Time 1)

Collaborators and Investigators

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

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Angela Fagerlin, PhD MA, VA Ann Arbor Healthcare System

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

August 1, 2008

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

February 6, 2007

First Submitted That Met QC Criteria

February 6, 2007

First Posted (ESTIMATE)

February 8, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 05-283

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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