Understanding the Challenges, Behavioral Patterns, and Preferences Towards Participation in Clinical Trials in Minority Patient Populations: Development and Validation of a Personalized Clinical Trial Educational Platform to Boost Participation Among Underserved Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 590
- 试验地点
- 6
- 主要终点
- Documentation of patient preferences, understanding, and attitudes regarding clinical trials (part I)
研究概览
简要总结
This clinical trial investigates the challenges, behavioral patterns, and preferences towards participation in clinical trials in minority patient populations in order to develop a personalized clinical trial educational platform to increase participation in clinical trials among underserved cancer patients. Learning more about patients' understanding of clinical trials may help identify barriers that limit patient's participation. Information gathered from this trial will be used to develop educational materials that may aid minority patients in overcoming barriers to participating in clinical trials. A personalized clinical trial educational platform may help increase participation in clinical trials among minority populations.
详细描述
PRIMARY OBJECTIVES:
I. To understand and document patient preferences, understanding, and attitudes regarding clinical trials.
II. To compare patient attitudes regarding clinical trials among cancer patients belonging to different racial/ethnic groups.
III. To establish the magnitude of existing knowledge gap relating to clinical trials among underserved cancer patients and the extent of improvement with a personalized educational approach.
IV. To determine how a personalized educational approach impacts enrollment in clinical trials of underserved cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 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
- •PART I: Subjects must be adults with age >= 18 years at the time of study entry
- •PART I: Subjects with any cancer diagnosis may be included
- •PART I: Subjects must be identified as new patients to hematology oncology at the treating site
- •PART I: Subjects must be willing to provide informed consent for the study
- •PART II: Subjects must be adults with age >= 18 years at the time of study entry
- •PART II: Subjects with any cancer diagnosis may be included
- •PART II: Subjects must be identified as new patients to hematology oncology at the treating site
- •PART II: Subjects must be willing to provide informed consent for the study
排除标准
- •PART I: Patients reported to have an estimated life-expectancy of < 6 months, as assessed by their clinician
- •PART I: Patients not willing to complete the Clinical Trials Study survey
- •PART II: Patients reported to have an estimated life-expectancy of < 6 months, as assessed by their clinician
- •PART II: Patients not willing to complete the education intervention or continued follow up for at least 2 years
研究组 & 干预措施
Part II: Arm B (clinical trial education, navigation)
Patients undergo clinical trial education via a video and educational booklet and then undergo patient navigation with active clinical trial matching and receive clinical trial information through the electronic medical record portal on study.
干预措施: Questionnaire Administration (Other)
Part I (questionnaire, medical record review)
Patients complete a questionnaire about their preferences, understanding, and attitudes regarding clinical trials. Patients also have their medical records reviewed.
干预措施: Electronic Health Record Review (Other)
Part I (questionnaire, medical record review)
Patients complete a questionnaire about their preferences, understanding, and attitudes regarding clinical trials. Patients also have their medical records reviewed.
干预措施: Questionnaire Administration (Other)
Part II: Arm A (clinical trial education, standard of care)
Patients undergo clinical trial education via a video and educational booklet and then standard of care follow-up on study.
干预措施: Best Practice (Other)
Part II: Arm A (clinical trial education, standard of care)
Patients undergo clinical trial education via a video and educational booklet and then standard of care follow-up on study.
干预措施: Educational Intervention (Other)
Part II: Arm A (clinical trial education, standard of care)
Patients undergo clinical trial education via a video and educational booklet and then standard of care follow-up on study.
干预措施: Electronic Health Record Review (Other)
Part II: Arm A (clinical trial education, standard of care)
Patients undergo clinical trial education via a video and educational booklet and then standard of care follow-up on study.
干预措施: Questionnaire Administration (Other)
Part II: Arm B (clinical trial education, navigation)
Patients undergo clinical trial education via a video and educational booklet and then undergo patient navigation with active clinical trial matching and receive clinical trial information through the electronic medical record portal on study.
干预措施: Best Practice (Other)
Part II: Arm B (clinical trial education, navigation)
Patients undergo clinical trial education via a video and educational booklet and then undergo patient navigation with active clinical trial matching and receive clinical trial information through the electronic medical record portal on study.
干预措施: Educational Intervention (Other)
Part II: Arm B (clinical trial education, navigation)
Patients undergo clinical trial education via a video and educational booklet and then undergo patient navigation with active clinical trial matching and receive clinical trial information through the electronic medical record portal on study.
干预措施: Electronic Health Record Review (Other)
Part II: Arm B (clinical trial education, navigation)
Patients undergo clinical trial education via a video and educational booklet and then undergo patient navigation with active clinical trial matching and receive clinical trial information through the electronic medical record portal on study.
干预措施: Patient Navigation (Behavioral)
结局指标
主要结局
Documentation of patient preferences, understanding, and attitudes regarding clinical trials (part I)
时间窗: Baseline
Overall percentages of the individual categories for each item of the survey will be summarized across all individuals. Any continuous items collected will be summarized using Means and/or medians depending on the distribution of the data. Most of this analysis will be exploratory and viewed as hypothesis generating.
Comparison of patient attitudes regarding clinical trials among cancer patients belonging to different racial/ethnic groups (part I)
时间窗: Baseline
Overall percentages of the individual categories for each item of the survey will be summarized across all individuals. Most of this analysis will be exploratory and viewed as hypothesis generating.
Knowledge score (part II)
时间窗: Baseline
Knowledge score at baseline in underserved groups will be compared with knowledge score of non-underserved cancer patients in the study.
Change in knowledge score (part II)
时间窗: Baseline up to 6 and 12 months
Knowledge score at baseline will be compared with scores at 6 months and 12 months. Scores of patients enrolled in the educational intervention and in the comparator arm will be reviewed.
Patient enrollment in a clinical trial
时间窗: Up to 24 months
The binary outcome of whether or not each patient is enrolled in a trial or not, focusing on the underserved patients. The proportion of patients enrolled in a trial will be compared in each of the two study arms.
次要结局
未报告次要终点