CClinicalTrials.gg
TerminatedNCT04630431Updated Jun 4, 2026

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

An interventional study of Best Practice and Educational Intervention in Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, sponsored by Mayo Clinic. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Health services research

Why this study was terminated
Low/slow accrual

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Oct 2019, registered Nov 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
590
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm
03

In context

Hematologic Neoplasms

1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.

This study's enrollment of 590 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
590 participants (actual)

Study arms

  • Experimental
    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.

    Other: Electronic Health Record Review · Other: Questionnaire Administration

  • Active comparator
    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.

    Other: Best Practice · Other: Educational Intervention · Other: Electronic Health Record Review · Other: Questionnaire Administration

  • Experimental
    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.

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

Interventions

  • OtherBest Practice

    Undergo standard of care follow-up

    Also known as: standard of care, standard therapy

  • OtherEducational Intervention

    Undergo clinical trial education via a video and educational booklet

    Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

  • OtherElectronic Health Record Review

    Review of medical record

  • BehavioralPatient Navigation

    Undergo clinical trial navigation

    Also known as: Patient Navigator Program

  • OtherQuestionnaire Administration

    Complete questionnaire

06

What researchers measure

Primary outcomes

  1. 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. Most of this analysis will be exploratory and viewed as hypothesis generating.

    Time frame: Baseline

  2. 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. Most of this analysis will be exploratory and viewed as hypothesis generating.

    Time frame: Baseline

  3. Knowledge score (part II)

    Knowledge score at baseline in underserved groups will be compared with knowledge score of non-underserved cancer patients in the study.

    Time frame: Baseline

  4. Change in knowledge score (part II)

    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.

    Time frame: Baseline up to 6 and 12 months

  5. 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. The proportion of patients enrolled in a trial will be compared in each of the two study arms.

    Time frame: Up to 24 months

07

Study locations

3 sites
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04630431
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Nov 16, 2020
Start date
Oct 15, 2019
Primary completion
Apr 12, 2022
Completion
Apr 12, 2022
Last update
Jun 4, 2026

Study contacts

Sikander Ailawadhi, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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