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

Mayo Clinic

Status: Active, not recruiting

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Treatments: Other: Questionnaire Administration; Behavioral: Patient Navigation; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Best Practice

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04630431

NCI-2020-08521 (Registry Identifier)

19-004014 (Other Identifier)

MC220901

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 590 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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590 participants in 3 patient groups

Part I (questionnaire, medical record review)

Experimental group

Description:

Patients complete a questionnaire about their preferences, understanding, and attitudes regarding clinical trials. Patients also have their medical records reviewed.

Treatment:

Other: Electronic Health Record Review

Other: Questionnaire Administration

Part II: Arm A (clinical trial education, standard of care)

Active Comparator group

Description:

Patients undergo clinical trial education via a video and educational booklet and then standard of care follow-up on study.

Treatment:

Other: Electronic Health Record Review

Other: Best Practice

Other: Educational Intervention

Other: Questionnaire Administration

Part II: Arm B (clinical trial education, navigation)

Experimental group

Description:

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.

Treatment:

Other: Electronic Health Record Review

Other: Best Practice

Behavioral: Patient Navigation

Other: Educational Intervention

Other: Questionnaire Administration