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

University of North Carolina (UNC)

Status: Completed

Conditions: Prostate Cancer

Treatments: Behavioral: Prostate cancer treatment DESI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01244568

10-1318

1R18AE000023-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

Usual care

No Intervention group

Prostate cancer treatment DESI

Experimental group

Treatment:

Behavioral: Prostate cancer treatment DESI