Choices for Latinas and Clinical Trials
Choices: Increasing Access of Latinas Into Breast Cancer Clinical Trials
研究概览
详细说明
This study features a cohort design with random assignment of 112 Latina breast cancer patients from the CTRC to an intervention (56) or usual care control group (56). The intervention group will receive three components: 1) a culturally sensitive and individually tailored, 30-minute computer-based BCCT educational video; 2) a bilingual, low literacy booklet that encourages patients to communicate with family and friends; and 3) support from a patient navigator. The usual care control group will receive usual care breast cancer clinical trial information materials offered by the CTRC to its eligible patients. The intervention is based in two proven theories - Stages of Change and Social Cognitive Theory - and will feature basic components of individual empowerment, including knowledge, attitudes, skills and self-efficacy beliefs and expectations.
The study has three main phases: Phase 1: Formative Research; Phase 2: Intervention; and Phase 3: Evaluation.
Purpose:
To empower Latinas to make informed decisions about breast cancer clinical trials (BCCTs) by enhancing their knowledge, attitudes, skills and self-efficacy required to support discussion of CT as a treatment option with doctors and family members.
Specific Objectives:
- Increase patient education and awareness, positive attitudes and self-efficacy to enhance their decision-making skills to participate in BCCTs.
- Provide decisional support to make an informed decision regarding participation in BCCTs by encouraging discussion of BCCTs as a treatment option with medical team, family and friends.
- Test the efficacy of a multi-communication intervention to assist Latina breast cancer patients in their decision making process regarding participation in BCCTs.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Texas
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San Antonio、Texas、美国、78229
- Cancer Therapy and Research Center - CTRC
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- English and Spanish speaking Latinas diagnosed with breast cancer who: attend the CTRC breast clinic and/or other CTRC clinics, have not had their initial doctor consultation to discuss treatment options, have not participated in a clinical trial before, and are eligible to participate in one of the Phase III, Phase IV or selective Phase II breast cancer clinical trials (BCCT) open at the CTRC at the time of diagnosis.
Exclusion Criteria:
- Non-Hispanic women
- Children
- Men
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Intervention
The intervention group will receive three components: 1) a culturally sensitive, individually tailored, 30-minute computer-based BCCT video; 2) a bilingual, low-literacy booklet aimed at encouraging patients to communicate with family and friends and 3) assistance from a patient navigator.
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Intervention includes 1) a 30-minute computer-based video (in English/Spanish), featuring instructional screens, graphics and animation to help participants understand the concepts presented.
It will feature breast cancer patients who have participated in CTs, patients talking to their doctor or nurse and a bilingual narrator to guide participants.
Video content will address common barriers and concerns regarding clinical trials, as well as the informed consent process, and how clinical trials are monitored and reviewed; 2) a bilingual easy to understand booklet with tailored information on clinical trials.
The booklet will include many of the elements and messages featured in the video program; and 3) assistance from a trained, bilingual, bicultural, nurse navigator.
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无干预：Usual Care
The usual care control group will receive the usual care breast cancer clinical trial information materials offered by the CTRC to their eligible patients.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Attitudes towards clinical trials
大体时间：Baseline and post intervention survey within 3 months from baseline
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Eight-item scale measuring attitudes towards clinical trials (staging questions)
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Baseline and post intervention survey within 3 months from baseline
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Self-efficacy
大体时间：Baseline and post intervention survey within 3 months from baseline
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14-item scale measuring self-efficacy regarding seeking information about clinical trials, communication with doctors, family members and friends, confidence in the system, decision making and expectations if enrolled in a clinical trial.
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Baseline and post intervention survey within 3 months from baseline
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Enrollment in a Clinical Trial
大体时间：within 6 months from baseline
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Participants' medical records will be reviewed to determine enrollment in a CT
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within 6 months from baseline
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合作者和调查者
调查人员
- 首席研究员：Amelie G. Ramirez, DrPH、The University of Texas Health Science Center at San Antonio
出版物和有用的链接
一般刊物
- Chalela P, Muñoz E, Gallion JK, Karnad A, Ramirez AG. Empowering Latina breast cancer patients to make informed decisions about clinical trials: A multicommunication approach. Cancer Epidemiol Biomarkers Prev 24(10 Suppl), 2015 [abstract]
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.