EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options - RCT of Usual Chemotherapy Educational Tools Versus Investigational Chemotherapy Educational Tools
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 10
- 主要终点
- Number of Participants With Accurate Understanding of Chemotherapy Benefits at 8-12 Weeks
研究概览
简要总结
The objective of this study is to improve the chemotherapy decision making process for Latinos with advanced gastrointestinal cancers. In this study Latinos who are considering 1st line chemotherapy for newly diagnosed advanced colorectal or pancreatic cancer will be randomized to usual care or to usual care supplemented by a Spanish/English language multimedia chemotherapy educational intervention. Primary informal caregivers will also be invited to participate.
This research study is evaluating if a new set of educational materials will improve the treatment decision-making process for Latinos with advanced gastrointestinal cancers. This research study will involve about 154 patients and 154 caregivers.
详细描述
There is growing evidence of racial/ethnic disparities in the quality of communication between oncologists and Latinos with cancer. These communication disparities are evidenced by gaps in Latino's understanding of their condition and treatment options, and by worse satisfaction with provider communication. Limited English proficiency and health literacy are very common among Latinos, yet few interventions have been developed to help Latino cancer patients better understand their condition and treatment options.
In this study the investigators have partnered with Latino patients, providers, and researchers to develop a Spanish/English language intervention aimed at better informing Latinos with advanced gastrointestinal cancers about the risks and benefits of their chemotherapy options. Specifically, the intervention consists of a dual language, regimen-specific suite of videos and booklets explaining the most common chemotherapy options used to treat advanced colorectal cancer and advanced pancreatic cancer. The videos feature Latino patients describing their experiences on treatment, as well as clinicians describing factual information about treatment risks, benefits, and alternatives.
In this study, self-identifying Hispanic/Latino patients with metastatic colorectal cancer, locally advanced and metastatic pancreatic cancer considering treatment with first line chemotherapy will be randomized to the usual care, or to usual care supplemented by access to the relevant chemotherapy educational materials. Caregivers will also be enrolled on the study. Participants will be surveyed at baseline, 2-weeks post-treatment initiation, 2-3 months post-treatment initiation, and 4-6 months post-treatment initiation regarding their understanding of chemotherapy risks and benefits, decisional conflict, and other metrics of informed decision-making.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identify as Hispanic/Latino
- •Has been diagnosed with metastatic colorectal cancer (mCRC) OR locally advanced pancreatic cancer (LAPC) OR metastatic pancreatic cancer (mPC) AND is making a decision regarding treatment with 1st line palliative chemotherapy
- •Treating oncologist has recommended consideration of one or more of the regimens for which we have developed chemotherapy educational (CEI) toolkits
- •For mCRC: FOLFOX, FOLFOX + bevacizumab, FOLFIRI, FOLFIRI + bevacizumab
- •For LAPC or mPC: FOLFIRINOX, Gemcitabine, or Gemcitabine + nab-paclitaxel
- •Patients who are also considering treatment on a clinical trial of one of these regimens +/- an investigational agent would still be eligible, so long as the treating MD believes to the content of the CEI to be relevant to the trial regimen.
- •Planning to receive treatment at the enrolling site
- •English or Spanish proficient
- •Caregiver Inclusion Criteria:
- •Caregivers of eligible patient participants
- •English or Spanish proficient
排除标准
- •For mCRC patients: Patients with oligometastatic disease who have a definitive plan for curative surgical resection are not eligible.
- •Significant delirium/dementia as judged by the treating oncologist
结局指标
主要结局
Number of Participants With Accurate Understanding of Chemotherapy Benefits at 8-12 Weeks
时间窗: 8-12 weeks
Participants were asked how likely they thought chemotherapy was to cure their cancer (response options: very likely, somewhat likely, a little likely, not at all likely, don't know). Not at all likely is considered accurate, all other responses are considered inaccurate.
次要结局
- Communication Satisfaction as Measured by 5 Items From the CAHPS Cancer Care Survey(2 weeks)
- Understanding of Chemotherapy Risks(2 weeks)
- Satisfaction With Chemotherapy Educational Materials Assessed on a 5-point Likert Scale.(2 weeks)
- Decisional Conflict as Measured by the 4-item SURE(2 weeks)
- Decisional Regret(3 months)
- Discussions About End-of-life Care Preferences With Healthcare Proxy and Care Team(3 months)
- Achievement of Preferred Role in Treatment Decision Making Process, as Measured by Degner's Control Preferences Scale(2 weeks)
研究者
Andrea Enzinger
Principal Investigator
Dana-Farber Cancer Institute