Improving Informed Decision Making for Cancer Clinical Trial Participation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 581
- 试验地点
- 1
- 主要终点
- Proportion of patients who show intention to participate or to consider CTs as an appropriate treatment option for cancer.
研究概览
简要总结
The goal of this study is to develop and pilot test a multi-communication approach to improve informed decision-making about cancer Clinical Trials (CTs) participation by increasing awareness of CTs and Mays Cancer Center (MCC) services (treatment care capacities, reputation and resources), positive attitudes towards CTs, self-efficacy and intentions to consider CTs as an appropriate treatment option for cancer (intention to participate) among patients attending the MCC (clinic-based setting) and the general public in selected Bexar County areas (community-based settings).
详细描述
The proposed two-year study involves a randomized controlled educational trial featuring a 2-group parallel cohort design with random assignment of 400 cancer patients from the MCC to the intervention or usual care control group. Intervention participants will receive 3 components: 1) a bilingual culturally relevant educational video, 2) a low-literacy booklet and 3) support from a patient navigator to empower new cancer patients to make informed decisions about cancer CT participation by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider CTs as an appropriate treatment option for cancer. The usual care control group will receive a general CT fact sheet.
The community setting will involve a community awareness campaign including 400 community members, with 3 components: 1) an educational session delivered via PowerPoint presentation or flip chart, 2) a low-literacy booklet, and 3) support from a community health educator to raise awareness, positive attitudes and intentions to consider CTs as an appropriate treatment option for cancer and promote the MCC services among community members in Bexar County.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed cancer patients (within 1 year) attending any of the clinics at the MCC
- •Patients who have not participated in a Clinical Trial before
- •English or Spanish-speaking
- •Able to provide informed consent
排除标准
- •Younger than 18 years
- •Patients who have already had a consultation with their doctor to discuss treatment options
- •Patients who have participated in a Clinical Trial before
- •Unable to provide informed consent
研究组 & 干预措施
Intervention Group
Participants in the intervention group will receive 3 components: 1) a bilingual, culturally tailored clinical trial educational video, 2) a low literacy booklet, and 3) support from a patient navigator to empower cancer patients to make informed decisions about cancer clinical trial participation by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider clinical trials as an appropriate treatment option for cancer.
干预措施: Clinical Trial Educational Video (Other)
Intervention Group
Participants in the intervention group will receive 3 components: 1) a bilingual, culturally tailored clinical trial educational video, 2) a low literacy booklet, and 3) support from a patient navigator to empower cancer patients to make informed decisions about cancer clinical trial participation by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider clinical trials as an appropriate treatment option for cancer.
干预措施: Low literacy booklet (Other)
Intervention Group
Participants in the intervention group will receive 3 components: 1) a bilingual, culturally tailored clinical trial educational video, 2) a low literacy booklet, and 3) support from a patient navigator to empower cancer patients to make informed decisions about cancer clinical trial participation by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider clinical trials as an appropriate treatment option for cancer.
干预措施: Navigator (Other)
Usual Care Control Group
Participants in the usual care control group will receive a general clinical trial fact sheet.
干预措施: Clinical Trial Fact Sheet (Other)
结局指标
主要结局
Proportion of patients who show intention to participate or to consider CTs as an appropriate treatment option for cancer.
时间窗: Up to 3 months after the index oncology visit
The percentage of patients who increased intentions to participate in a CT after the intervention compared with baseline.
次要结局
- Proportion of patients who show increase in knowledge/awareness regarding CT participation.(Up to 3 months after the index oncology visit)
- Proportion of patients who show improved attitudes regarding CT participation.(Up to 3 months after the index oncology visit)
- Proportion of patients eligible for designated clinical trials who actually enroll in one of these trials.(Up to 3 months after the index oncology visit)
研究者
Patricia Chalela
Associate Professor
The University of Texas Health Science Center at San Antonio