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| ID | Type | Description | Link |
|---|---|---|---|
| 1R18AE000023-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Palo Alto Medical Foundation | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | ||
| Prostate cancer treatment DESI | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate cancer treatment DESI | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Age 45 or older Localized prostate cancer with a Gleason score of 6 or less
Exclusion Criteria:
Women
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| Name | Affiliation | Role |
|---|---|---|
| Carmen L Lewis, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Ming Tai-Seale, Ph.D, MPH | Palo Alto Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto Medical Foundation Research Institute | Palo Alto | California | 94301 | United States | ||
| University of North Carolina, Chapel Hill |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Research staff will review EMR data to access decision-making outcomes and resource utilization. |
| 6 month follow-up |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |