Prostate Cancer
Conditions
Keywords
decision aid, focus group
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDecision Aid Tool
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.
BEHAVIORALbaseline survey
patients will be given baseline surveys to gather demographic information and readiness to make a decision regarding prostate cancer care
BEHAVIORALfollow-up surveys
at 3, 6, 9, and 12 months patients will be given follow-up surveys regarding prostate cancer care
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects utilize English or Spanish as their primary spoken or written language and identify with a Latino ethnicity and/or culture * Men with a new histologic diagnosis of localized prostate cancer * PSA level of 0.1 - 50 ng/dl * Gleason score of 6 - 10 * Cancer stage: T1 - 4N x M0
Exclusion criteria
* Metastatic disease, including lymph nodes or distant metastasis * PSA \> 50 ng/dl * Individuals with a medical condition that necessitates a specific prostate cancer treatment plan * Individuals that are unwilling or unable to attend study visits or are planning to move out of a study site coverage area during the subject's anticipated participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision Quality of cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer | Up to 12 months | Decisional quality will be measured by the O'Connor Decisional Conflict Scale |
| Knowledge of prostate cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer | Up to 12 months | Prostate cancer knowledge will be measured by the Knowledge Measurement Tool |
| Patient satisfaction in low-income Hispanic/Latino patients diagnosed with localized prostate cancer | Up to 12 months | Patient satisfaction will be measured by the CAPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) patient satisfaction measurement tool |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer | Up to 12 months | Health-related quality of life will be measured by the EPIC (Expanded Prostate Cancer Index Composite) assessment tool |
Outcome results
None listed