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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244568
• Other study ID #: 10-1318
• Secondary ID: 1R18AE000023-01
• Status: Completed
• Phase: N/A
• First received: November 15, 2010
• Last updated: December 19, 2014
• Start date: December 2010
• Est. completion date: January 2013

Study information

• Verified date: August 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Women

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	Palo Alto Medical Foundation Research Institute	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Allergy and Infectious Diseases (NIAID), Palo Alto Medical Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	Healthcare utilization	Research staff will review EMR data to access decision-making outcomes and resource utilization.	6 month follow-up	No