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Study Team did not respond to requests for continuing review approval.
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A pilot study testing the effect of an in-visit English and Spanish language decision aid for Hispanic-Latino men using best practices of cultural tailoring to be used in urology practice. Subjects will be followed for approximately 1 year during standard care in-clinic office visits. Study results and subject surveys will be analyzed to determine clinical utility of the tool.
The objective of this research is to determine the effect of a culturally tailored decision aid tool on the cancer treatment decisions of Hispanic-Latino patients.
The specific aims are:
i. To develop and pilot test in an uncontrolled fashion an in-visit English and Spanish language decision aid for Hispanic-Latino men using best practices of cultural tailoring to be used in urology practice ii. To pilot and test the impact of a culturally tailored, English and Spanish language version of the Prostate Choice in-visit decision aid on decision quality, knowledge, and quality of life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer iii. To assess the barriers and facilitators of decision aid use including the relative contribution of language-concordance on 1-year practice implementation parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision Aid | Experimental | Subjects will be asked to complete baseline surveys. Once the surveys are completed, subjects will review the Decision Aid tool with a study team member. Once the subjects have gone through the tool, study team members will answer any additional questions he may have regarding the tool. The subjects will then discuss with the investigator various cancer management options, quality of life implications, and any questions the subjects may have regarding cancer management options. Subjects that are ready may make a cancer management decision at this time, or choose to wait until their next scheduled visit. Subjects will be followed at subsequent urology clinic visits for up to 6 months. Subjects will complete follow-up surveys at the 3, 6, 9 and 12 month visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid Tool | Behavioral | Subjects will be given an I-pad with the decision aid program on it. A member of the study team will enter some preliminary information, then the subject will be able to review the tool with his doctor. |
| Measure | Description | Time Frame |
|---|---|---|
| Decision Quality of cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer | Decisional quality will be measured by the O'Connor Decisional Conflict Scale | Up to 12 months |
| Knowledge of prostate cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer | Prostate cancer knowledge will be measured by the Knowledge Measurement Tool | Up to 12 months |
| Patient satisfaction in low-income Hispanic/Latino patients diagnosed with localized prostate cancer | Patient satisfaction will be measured by the CAPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) patient satisfaction measurement tool | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer | Health-related quality of life will be measured by the EPIC (Expanded Prostate Cancer Index Composite) assessment tool | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon P Kim, MD, MPH | University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
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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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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| baseline survey | Behavioral | patients will be given baseline surveys to gather demographic information and readiness to make a decision regarding prostate cancer care |
|
| follow-up surveys | Behavioral | at 3, 6, 9, and 12 months patients will be given follow-up surveys regarding prostate cancer care |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |