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

Malignant Solid Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04630431
• Other study ID #: MC220901
• Secondary ID: NCI-2020-0852119
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: October 15, 2024

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3250
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Best Practice
Undergo standard of care follow-up
• Educational Intervention
Undergo clinical trial education via a video and educational booklet
• Electronic Health Record Review
Review of medical record

Behavioral:
• Patient Navigation
Undergo clinical trial navigation

Other:
• Questionnaire Administration
Complete questionnaire

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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