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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prostate cancer treatment DESI
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Decision support interventions (DESI), Comparative Effectiveness Research (CER)

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Women

Sites / Locations

  • Palo Alto Medical Foundation Research Institute
  • University of North Carolina, Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Prostate cancer treatment DESI

Arm Description

Outcomes

Primary Outcome Measures

Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months
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
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
Research staff will review EMR data to access decision-making outcomes and resource utilization.

Full Information

First Posted
November 15, 2010
Last Updated
December 19, 2014
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Palo Alto Medical Foundation, National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT01244568
Brief Title
Decision Support Interventions (DESI) for Prostate Cancer Screening and Treatment - Study 2
Official Title
Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment- Study 2
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Palo Alto Medical Foundation, National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Decision support interventions (DESI), Comparative Effectiveness Research (CER)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Title
Prostate cancer treatment DESI
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Prostate cancer treatment DESI
Other Intervention Name(s)
Decision Support Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months
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.
Time Frame
3 and 6 month follow-up
Secondary Outcome Measure Information:
Title
DESI viewing
Description
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.
Time Frame
3 month follow-up (phone survey)
Title
Healthcare utilization
Description
Research staff will review EMR data to access decision-making outcomes and resource utilization.
Time Frame
6 month follow-up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 45 or older Localized prostate cancer with a Gleason score of 6 or less Exclusion Criteria: Women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen L Lewis, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ming Tai-Seale, Ph.D, MPH
Organizational Affiliation
Palo Alto Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto Medical Foundation Research Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
Facility Name
University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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