Development and Testing of a Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Patient satisfaction in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Decision Aid
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.
干预措施: Decision Aid Tool (Behavioral)
Decision Aid
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.
干预措施: baseline survey (Behavioral)
Decision Aid
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.
干预措施: follow-up surveys (Behavioral)
结局指标
主要结局
Patient satisfaction in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
时间窗: Up to 12 months
Patient satisfaction will be measured by the CAPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) patient satisfaction measurement tool
Decision Quality of cancer care in low-income Hispanic/Latino patients diagnosed with localized prostate cancer
时间窗: 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
时间窗: Up to 12 months
Prostate cancer knowledge will be measured by the Knowledge Measurement Tool
次要结局
- Quality of Life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer(Up to 12 months)