Clinical trial NCT04630431: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Documentation of patient preferences, understanding, and attitudes regarding clinical trials (part I)
timeFrame: Baseline
measure: Comparison of patient attitudes regarding clinical trials among cancer patients belonging to different racial/ethnic groups (part I)
timeFrame: Baseline
measure: Knowledge score (part II)
timeFrame: Baseline
measure: Change in knowledge score (part II)
timeFrame: Baseline up to 6 and 12 months
measure: Patient enrollment in a clinical trial
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sikander Ailawadhi, MD
role: PRINCIPAL_INVESTIGATOR
References: