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Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment- Study 2


N/A
45 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment- Study 2


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.


Inclusion Criteria:



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

Exclusion Criteria:

Women

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months

Outcome Description:

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.

Outcome Time Frame:

3 and 6 month follow-up

Safety Issue:

No

Principal Investigator

Carmen L Lewis, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill

Authority:

United States: Institutional Review Board

Study ID:

10-1318

NCT ID:

NCT01244568

Start Date:

December 2010

Completion Date:

July 2013

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Decision support interventions (DESI)
  • Comparative Effectiveness Research (CER)
  • Prostatic Neoplasms

Name

Location

University of North Carolina, Chapel Hill Chapel Hill, North Carolina  27599
Palo Alto Medical Foundation Research Institute Palo Alto, California  94301