Understanding the Challenges, Behavioral Patterns, and Preferences Towards Participation in Clinical Trials in Minority Patient Populations for the Development of a Personalized Clinical Trial Educational Platform to Increase Participation in Clinical Trials Among Underserved Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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. OUTLINE: PART I: Patients complete a questionnaire about their preferences, understanding, and attitudes regarding clinical trials. Patients also have their medical records reviewed. PART II: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo clinical trial education via a video and educational booklet and then standard of care follow-up on study. ARM B: 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.

Official Title
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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

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Best Practice
* Other: Educational Intervention
* Other: Electronic Health Record Review
* Behavioral: Patient Navigation
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part I (questionnaire, medical record review)<br>Patients complete a questionnaire about their preferences, understanding, and attitudes regarding clinical trials. Patients also have their medical records reviewed. | Other: Electronic Health Record Review<br>* Review of medical record<br>Other: Questionnaire Administration<br>* Complete questionnaire<br>|
| Active Comparator: Part II: Arm A (clinical trial education, standard of care)<br>Patients undergo clinical trial education via a video and educational booklet and then standard of care follow-up on study. | Other: Best Practice<br>* Undergo standard of care follow-up<br>* Other names: standard therapy;Other: Educational Intervention<br>* Undergo clinical trial education via a video and educational booklet<br>* Other names: Intervention, Educational;Other: Electronic Health Record Review<br>* Review of medical record<br>Other: Questionnaire Administration<br>* Complete questionnaire<br>|
| Experimental: Part II: Arm B (clinical trial education, navigation)<br>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. | Other: Best Practice<br>* Undergo standard of care follow-up<br>* Other names: standard therapy;Other: Educational Intervention<br>* Undergo clinical trial education via a video and educational booklet<br>* Other names: Intervention, Educational;Other: Electronic Health Record Review<br>* Review of medical record<br>Behavioral: Patient Navigation<br>* Undergo clinical trial navigation<br>* Other names: Patient Navigator Program;Other: Questionnaire Administration<br>* Complete questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of patient preferences, understanding, and attitudes regarding clinical trials (part I) | 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. Any categorical items will be potentially compared between groups using Chi-square tests. Continuous measures maybe compared using analysis of variance. Most of this analysis will be exploratory though and viewed as hypothesis generating. | Baseline | 
| Comparison of patient attitudes regarding clinical trials among cancer patients belonging to different racial/ethnic groups (part I) | 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. Any categorical items will be potentially compared between groups using Chi-square tests. Continuous measures maybe compared using analysis of variance. Most of this analysis will be exploratory though and viewed as hypothesis generating. | Baseline | 
| Knowledge score (part II) | Linear regression to compare knowledge score at baseline in underserved groups with the rest of the cancer patients in the study with adjustment for relevant covariates. We will obtain an estimate of the difference in mean scores along with a 95% confidence interval (CI). | Baseline | 
| Change in knowledge score (part II) | Linear regression to compare change in knowledge score in patients enrolled in the educational intervention versus in the comparator arm. We will adjust for baseline score and obtain an estimated of the difference in mean score change along with a 95% CI. | Baseline up to 6 and 12 months | 
| Patient enrollment in a clinical trial | The binary outcome of whether or not each patient is enrolled in a trial or not, focusing on the underserved patients. A predetermined randomization algorithm/schedule will be utilized. Logistic regression will be used to compare the proportion of patients enrolled in a trial in each of the two study arms. Adjustments will be made for baseline covariates known to be associated with trial participation. A likelihood ratio test will be conducted of the null hypothesis of no difference in proportions in the two groups. The associated odds ratio will be estimated along with a 95% CI. Comparisons will also be made with the non-underserved patients in which the proportion enrolling in trials is expected to be much higher, with or without the intervention. | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of baseline patient characteristics (socioeconomic status, level of education, social support, among others) with the patient's preferences and understanding regarding clinical trials (part I) | Will be obtained from the Epic electronic medical record and from the baseline survey. 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. Any categorical items will be potentially compared between groups using Chi-square tests. Continuous measures maybe compared using analysis of variance. Most of this analysis will be exploratory though and viewed as hypothesis generating. | Baseline | 
| Association of disease state (newly diagnosed versus previously treated) with patients understanding and behavior towards clinical trial participation (part I) | 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. Any categorical items will be potentially compared between groups using Chi-square tests. Continuous measures maybe compared using analysis of variance. Most of this analysis will be exploratory though and viewed as hypothesis generating. | Baseline |