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 Clinic590 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Interventions

Best PracticeOTHER

Undergo standard of care follow-up

Educational InterventionOTHER

Undergo clinical trial education via a video and educational booklet

Electronic Health Record ReviewOTHER

Review of medical record

Patient NavigationBEHAVIORAL

Undergo clinical trial navigation

Questionnaire AdministrationOTHER

Complete questionnaire

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes