Understanding the Challenges, Behavioral Patterns, and Preferences Towards Participation in Clinical Trials in Minority Patient Populations for the Development of a Personalized Clinical Trial Educational Platform to Increase Participation in Clinical Trials Among Underserved Cancer Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Electronic Health Record Review; Other: Best Practice; Other: Educational Intervention; Behavioral: Patient Navigation

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.

• Study Type: Interventional
• Enrollment (Estimated): 3250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Principal Investigator: Cassandra N. Moore, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Recruiting
      • Mayo Clinic in Florida
      • Principal Investigator: Sikander Ailawadhi, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Rahma M. Warsame, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Patients with cancer diagnosis who present for their initial visit to Mayo Clinic in Florida, Arizona, Rochester, or Mayo Clinic Cancer Center at St. Vincent's

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Questionnaire Administration; Complete questionnaire; Other: Electronic Health Record Review; Review of medical record
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: Questionnaire Administration; Complete questionnaire; Other: Electronic Health Record Review; Review of medical record; Other: Best Practice; Undergo standard of care follow-up; Other Names: standard of care; standard therapy; Other: Educational Intervention; Undergo clinical trial education via a video and educational booklet; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
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: Questionnaire Administration; Complete questionnaire; Other: Electronic Health Record Review; Review of medical record; Other: Best Practice; Undergo standard of care follow-up; Other Names: standard of care; standard therapy; Other: Educational Intervention; Undergo clinical trial education via a video and educational booklet; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Behavioral: Patient Navigation; Undergo clinical trial navigation; Other Names: Patient Navigator Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Any categorical items will be potentially compared between groups using Chi-square tests. Continuous measures maybe compared using analysis of variance. Most of this analysis will be exploratory though 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. Any continuous items collected will be summarized using Means and/or medians depending on the distribution of the data. Any categorical items will be potentially compared between groups using Chi-square tests. Continuous measures maybe compared using analysis of variance. Most of this analysis will be exploratory though and viewed as hypothesis generating.	Baseline
Knowledge score (part II)	Linear regression to compare knowledge score at baseline in underserved groups with the rest of the cancer patients in the study with adjustment for relevant covariates. We will obtain an estimate of the difference in mean scores along with a 95% confidence interval (CI).	Baseline
Change in knowledge score (part II)	Linear regression to compare change in knowledge score in patients enrolled in the educational intervention versus in the comparator arm. We will adjust for baseline score and obtain an estimated of the difference in mean score change along with a 95% CI.	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. A predetermined randomization algorithm/schedule will be utilized. Logistic regression will be used to compare the proportion of patients enrolled in a trial in each of the two study arms. Adjustments will be made for baseline covariates known to be associated with trial participation. A likelihood ratio test will be conducted of the null hypothesis of no difference in proportions in the two groups. The associated odds ratio will be estimated along with a 95% CI. Comparisons will also be made with the non-underserved patients in which the proportion enrolling in trials is expected to be much higher, with or without the intervention.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of baseline patient characteristics (socioeconomic status, level of education, social support, among others) with the patient's preferences and understanding regarding clinical trials (part I)	Will be obtained from the Epic electronic medical record and from the baseline survey. 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. Any categorical items will be potentially compared between groups using Chi-square tests. Continuous measures maybe compared using analysis of variance. Most of this analysis will be exploratory though and viewed as hypothesis generating.	Baseline
Association of disease state (newly diagnosed versus previously treated) with patients understanding and behavior towards clinical trial participation (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. Any categorical items will be potentially compared between groups using Chi-square tests. Continuous measures maybe compared using analysis of variance. Most of this analysis will be exploratory though and viewed as hypothesis generating.	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sikander Ailawadhi, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Estimated): October 15, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MC220901; 19-004014 (Other Identifier: Mayo Clinic); NCI-2020-08521 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No