An interventional study of Decision Aid Tool and baseline survey in Prostate Cancer, sponsored by Case Comprehensive Cancer Center. Withdrawn. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-05.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
Browse Prostatic Neoplasms studies →Case Comprehensive Cancer Center is the lead sponsor of 493 studies on the registry; 59 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
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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.
Behavioral: Decision Aid Tool · Behavioral: baseline survey · Behavioral: follow-up surveys
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.
patients will be given baseline surveys to gather demographic information and readiness to make a decision regarding prostate cancer care
at 3, 6, 9, and 12 months patients will be given follow-up surveys regarding prostate cancer care
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
Time frame: 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
Time frame: 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
Time frame: Up to 12 months
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
Time frame: Up to 12 months
No study locations are listed for this record.
Started Aug 2017 (actual). Primary completion is estimated for Jun 2019, 22 months after the start.
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This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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