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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Prostate cancer treatment DESI

• Registration Number: NCT01244568
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Study Start: 2010-12
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-08
• Last Update Submitted: 2014-12-19
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 218

Inclusion Criteria

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

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Exclusion Criteria

Women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prostate cancer treatment DESI	Prostate cancer treatment DESI	-

Primary Outcome Measures

Name	Time	Method
Comparison of Active treatment vs. Watchful waiting/active surveillance at 3 and 6 months	3 and 6 month follow-up	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

Name	Time	Method
DESI viewing	3 month follow-up (phone survey)	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	6 month follow-up	Research staff will review EMR data to access decision-making outcomes and resource utilization.

Trial Locations

Locations (2)

University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Palo Alto Medical Foundation Research Institute; 🇺🇸 Palo Alto, California, United States