Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Decision Support Interventions (DESI) for Prostate Cancer Screening and Treatment - Study 2

This study is ongoing, but not recruiting participants.
Palo Alto Medical Foundation
Information provided by (Responsible Party):
Carmen Lewis, MD, MPH, University of North Carolina, Chapel Hill Identifier:
First received: November 15, 2010
Last updated: June 21, 2013
Last verified: June 2013

Researchers in this study will determine whether providing decision support interventions (DESIs) to men with low risk prostate cancer improves their decision-specific knowledge and alters their treatment decisions.

Condition Intervention
Prostate Cancer
Behavioral: Prostate cancer treatment DESI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment- Study 2

Resource links provided by NLM:

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months [ Time Frame: 3 and 6 month follow-up ] [ Designated as safety issue: No ]
    Men who review a DESI before making a treatment decision will be more likely to choose active surveillance/watchful waiting and will have better decision-specific knowledge.

Secondary Outcome Measures:
  • DESI viewing [ Time Frame: 3 month follow-up (phone survey) ] [ Designated as safety issue: No ]
    Decision aid viewing is a self-reported measures. Patients will be asked if they viewed the DVD that was given to them (intervention group)prior to them making a treatment choice decision.

  • Healthcare utilization [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
    Research staff will review EMR data to access decision-making outcomes and resource utilization.

Enrollment: 218
Study Start Date: December 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care
Experimental: Prostate cancer treatment DESI Behavioral: Prostate cancer treatment DESI
DESI is a 50 minute program on treatment choices for prostate cancer that will be given out to the experimental group. The program explains several treatment options including surgery (radical prostatectomy), radiation therapy (external beam and/or brachytherapy), hormone therapy, and active surveillance and watchful waiting. The program's intended audience is men with early state prostate cancer who are trying to make a treatment decision.
Other Name: Decision Support Intervention

Detailed Description:

Potentially eligible men (age 45 and older who have localized prostate cancer with a Gleason score of 6 or less) will be identified and recruited to participate in the study before their next office visit. Patients who are interested and provide informed consent will be asked to complete a brief survey about background, medical history, knowledge of prostate cancer and health-related quality of life. Once the survey is completed the patient will be randomly assigned to one of 2 groups. Those assigned to the "Usual Care" group will not receive any additional information materials as part of their participation in the study. Those assigned to the "Patient Decision Support" group will receive a DVD program that contains information about treatment choices for prostate cancer.

Participants will be asked to answer a brief telephone survey at 3 and 6 months from the day of their last office visit. Survey questions will ask about knowledge about prostate cancer, health-related quality of life, whether or not the DVD was viewed and what treatment decision was made.

Research staff will also review medical records 6 months after enrollment to determine which treatment was received for prostate cancer, how many visits with health care providers were completed since enrollment and which medical services and procedures were received.


Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Age 45 or older Localized prostate cancer with a Gleason score of 6 or less

Exclusion Criteria:


  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01244568

United States, California
Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States, 94301
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Palo Alto Medical Foundation
Principal Investigator: Carmen L Lewis, MD, MPH University of North Carolina, Chapel Hill
Principal Investigator: Ming Tai-Seale, Ph.D, MPH Palo Alto Medical Foundation
  More Information

No publications provided

Responsible Party: Carmen Lewis, MD, MPH, Associate Professor, University of North Carolina, Chapel Hill Identifier: NCT01244568     History of Changes
Other Study ID Numbers: 10-1318, 1R18AE000023 - 01
Study First Received: November 15, 2010
Last Updated: June 21, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Prostate Cancer
Decision support interventions (DESI)
Comparative Effectiveness Research (CER)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on November 25, 2014