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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR009692 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| University of Washington | OTHER |
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The purpose of this study is to determine whether or not participation in an experimental program called the "P4 program" is useful to men who are faced with choices about treatment for their early stage prostate cancer. The P4 program consists of a series of questions and information for the participant.
Before seeing the cancer specialist, participants will answer several questionnaires on a computer. This will take about 20-30 minutes. Participants may choose to do this on a computer at home or on a touch-screen computer in the clinic. Half the participants will then be shown several highly rated informational websites about prostate cancer treatments. The other half, based on the individual participant's answers, will receive the P4 program's customized written and on-screen information. Reading the information and watching videos will take about 20 minutes.
About one month later, and again 6 months, participants will complete follow-up questionnaires electronically or by mail. These questionnaires will help us understand how each participant's decision for treatment of their prostate cancer went. Answering these questionnaires should take about 20 minutes each time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P4 | Experimental | Participant uses P4 program before meeting with his clinician to discuss treatment options. |
|
| Usual care+ | No Intervention | Usual care plus participant is directed to reputable websites highly rated in research literature to learn more about prostate cancer treatments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P4 | Behavioral | Tailored online decision support system for prostate cancer treatment decision making |
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| Measure | Description | Time Frame |
|---|---|---|
| Decisional Conflict | Baseline to 6 months | |
| Decisional Satisfaction | Baseline to 6 months | |
| Satisfaction with Preparation for Decision Making | Baseline to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Shift in decisional control preference from pre-decision to 1 month post-treatment | Baseline to 1 month | |
| Resource utilization | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth Wolpin, RN, PhD | University of Washington | Principal Investigator |
| Donna L Berry, RN, PhD | Dana-Farber Cancer Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center / Medical College of Georgia | Augusta | Georgia | 30904 | United States | ||
| Fox Chase Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25344101 | Derived | Underhill ML, Hong F, Berry DL. When study site contributes to outcomes in a multi-center randomized trial: a secondary analysis of decisional conflict in men with localized prostate cancer. Health Qual Life Outcomes. 2014 Oct 25;12:159. doi: 10.1186/s12955-014-0159-3. | |
| 23021156 | Derived | Bosco JL, Halpenny B, Berry DL. Personal preferences and discordant prostate cancer treatment choice in an intervention trial of men newly diagnosed with localized prostate cancer. Health Qual Life Outcomes. 2012 Sep 28;10:123. doi: 10.1186/1477-7525-10-123. |
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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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| Philadelphia |
| Pennsylvania |
| 19111 |
| United States |
| University of Texas Health Sciences Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Seattle Prostate Institute | Seattle | Washington | 98104 | United States |
| Veterans Administration Puget Sound Health Care System | Seattle | Washington | 98108 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| 22608696 | Derived | Berry DL, Wang Q, Halpenny B, Hong F. Decision preparation, satisfaction and regret in a multi-center sample of men with newly diagnosed localized prostate cancer. Patient Educ Couns. 2012 Aug;88(2):262-7. doi: 10.1016/j.pec.2012.04.002. Epub 2012 May 17. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |