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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Prostate cancer treatment DESI

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.

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

Women

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Decision Support Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 and 6 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 month follow-up (phone survey)
Healthcare utilization	Research staff will review EMR data to access decision-making outcomes and resource utilization.	6 month follow-up

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Palo Alto Medical Foundation

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: November 18, 2010
• First Posted (Estimate): November 19, 2010

Study Record Updates

• Last Update Posted (Estimate): December 23, 2014
• Last Update Submitted That Met QC Criteria: December 19, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Prostate Cancer; Decision support interventions (DESI); Comparative Effectiveness Research (CER)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 10-1318; 1R18AE000023-01 (U.S. NIH Grant/Contract)