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

NCT04630431 | Active Not Recruiting

• 3 other identifiers: MC220901NCI-2020-0852119-004014
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 3

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.

Conditions

Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (5)

• 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.

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

  Baseline

• 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.

  Baseline

• 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.

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

  Up to 24 months

Study Arms (3)

Part I (questionnaire, medical record review)

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

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

EXPERIMENTAL

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

Best Practice OTHER

Undergo standard of care follow-up

Also known as: standard of care, standard therapy

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

Educational Intervention OTHER

Undergo clinical trial education via a video and educational booklet

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

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

Electronic Health Record Review OTHER

Review of medical record

Part I (questionnaire, medical record review); Part II: Arm A (clinical trial education, standard of care); Part II: Arm B (clinical trial education, navigation)

Patient Navigation BEHAVIORAL

Undergo clinical trial navigation

Also known as: Patient Navigator Program

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

Questionnaire Administration OTHER

Complete questionnaire

Part I (questionnaire, medical record review); Part II: Arm A (clinical trial education, standard of care); Part II: Arm B (clinical trial education, navigation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods; Patient Navigation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management

Study Officials

• Sikander Ailawadhi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 16, 2020
• Study Start: October 15, 2019
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (3)