Understanding Challenges, Behavioral Patterns, and Preferences Toward Participation in Clinical Trials in Minority Patient Populations: Development of a Personalized Clinical Trial Educational Platform to Increase Participation in Clinical Trials Among Underserved Cancer Patients
NCT ID: NCT04630431
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
590 participants
INTERVENTIONAL
2019-10-15
2026-10-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
Electronic Health Record Review
Review of medical record
Questionnaire Administration
Complete questionnaire
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.
Best Practice
Undergo standard of care follow-up
Educational Intervention
Undergo clinical trial education via a video and educational booklet
Electronic Health Record Review
Review of medical record
Questionnaire Administration
Complete questionnaire
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.
Best Practice
Undergo standard of care follow-up
Educational Intervention
Undergo clinical trial education via a video and educational booklet
Electronic Health Record Review
Review of medical record
Patient Navigation
Undergo clinical trial navigation
Questionnaire Administration
Complete questionnaire
Interventions
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Best Practice
Undergo standard of care follow-up
Educational Intervention
Undergo clinical trial education via a video and educational booklet
Electronic Health Record Review
Review of medical record
Patient Navigation
Undergo clinical trial navigation
Questionnaire Administration
Complete questionnaire
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Sikander Ailawadhi, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2020-08521
Identifier Type: REGISTRY
Identifier Source: secondary_id
19-004014
Identifier Type: OTHER
Identifier Source: secondary_id
MC220901
Identifier Type: -
Identifier Source: org_study_id