Expanding Clinical Trial Awareness Among Black Communities Through Digital Engagement

Under-representation of patients from racial/ethnic minority groups in cancer clinical trials is a major barrier to health equity. Black patients are significantly less likely to be enrolled in clinical trials compared with non-Hispanic White (White) patients although they carry a disproportionate burden of cancer mortality, the shortest survival rates, and are more likely to be diagnosed at later stages. Further, medical mistrust and lack of awareness and complexity of clinical trials are barriers that reduce the likelihood of clinical trial participation. The objective of this pilot study is to understand the effect of a culturally tailored decision aid (previously developed by our research team) on 1) medical mistrust, 2) patient knowledge about clinical trials, and 3) decision-making self-efficacy and determine the acceptability of the decision aid among Black patients currently or ever been diagnosed with cancer.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Educational Intervention (Video); Other: Survey Administration

Detailed Description

This study will be conducted online through Qualtrics.

Participants will answer pre-test survey questions, watch the culturally tailored decision aid video [Fostering Opportunities in Research Using Marketing Strategies (FOR US)] intervention, then answer post-intervention survey questions.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Are 18 years of age or older
• Identify as Black/African- American
• Have Current or previous diagnosis of cancer
• Speak and understand English

Exclusion Criteria:

• Are younger than 18 years of age
• Do not identify as Black/African- American
• Do not have a current or previous diagnosis of cancer
• Are non - English-speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health Services Research; Participants watch a culturally tailored decision aid video. Surveys are completed before and after the video.	Other: Educational Intervention (Video); Watch video; Other Names: Fostering Opportunities in Research Using Marketing Strategies (FOR US); Other: Survey Administration; Answer survey questions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Medical Mistrust from Baseline to Post-Intervention: 12-item Group-Based Medical Mistrust Scale	Will assess the effect of a culturally tailored decision aid video on medical mistrust. Participants will complete the 12-item Group-Based Medical Mistrust Scale at baseline and post-intervention. This is a 12-item validated survey focused on healthcare provided in the social context of racism and discrimination. Item responses use a Likert-type scale with higher scores indicating higher agreement.	Baseline and post-intervention (up to 15 minutes)
Change in Trust in Health Information from Baseline to Post-Intervention: Health Information National Trends Survey (HINTS)	Will assess the effect of a culturally tailored decision aid video on trust in information. Participants will complete 6 items from the National Cancer Institute - Health Information National Trends Survey (HINTS). HINTS collects nationally representative data routinely about the American public's use of cancer-related information. HINTS comprises multiple choice questions about medical research and medical records and patient-provider communications.	Baseline and post-intervention (up to 15 minutes)
Change in Patient Knowledge from Baseline to Post-Intervention: Five unique question items	Will assess the effect of a culturally tailored decision aid video on patient knowledge about clinical trials via a five unique question items survey.	Baseline and post-intervention (up to 15 minutes)
Change in Clinical Trial Participation Decision-Making Self-Efficacy from Baseline to Post-Intervention: 11-item Decision Self-Efficacy Scale	Will assess the effect of a culturally tailored decision aid video on clinical trial participation decision-making self-efficacy using the 11-item Decision Self-Efficacy Scale. The 11-item Decision Self-Efficacy Scale measures self-confidence or belief in one's abilities in decision making. Possible scores range from 0 to 100, with higher scores indicating more decision self-efficacy and a better outcome.	Baseline and post-intervention (up to 15 minutes)
Acceptability of the intervention	Participants will complete a post-intervention survey to assess acceptability of the video intervention. This survey is a 5-item measure; items responded to on a Likert-type scale with higher scores indicating higher acceptability.	At post-intervention (up to 15 minutes)

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Investigators: Principal Investigator: Vida Henderson, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RG1124067; NCI-2024-00180 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); FHIRB0020288 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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