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Clinical Trials/NCT06218615
NCT06218615
Completed
Not Applicable

Expanding Clinical Trial Awareness Among Black Communities Through Digital Engagement

Fred Hutchinson Cancer Center1 site in 1 country109 target enrollmentJune 6, 2024
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Fred Hutchinson Cancer Center
Enrollment
109
Locations
1
Primary Endpoint
Change in Medical Mistrust from Baseline to Post-Intervention: 12-item Group-Based Medical Mistrust Scale
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 6, 2024
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Medical Mistrust from Baseline to Post-Intervention: 12-item Group-Based Medical Mistrust Scale

Time Frame: Baseline and post-intervention (up to 15 minutes)

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.

Change in Trust in Health Information from Baseline to Post-Intervention: Health Information National Trends Survey (HINTS)

Time Frame: Baseline and post-intervention (up to 15 minutes)

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.

Change in Patient Knowledge from Baseline to Post-Intervention: Five unique question items

Time Frame: Baseline and post-intervention (up to 15 minutes)

Will assess the effect of a culturally tailored decision aid video on patient knowledge about clinical trials via a five unique question items survey.

Change in Clinical Trial Participation Decision-Making Self-Efficacy from Baseline to Post-Intervention: 11-item Decision Self-Efficacy Scale

Time Frame: Baseline and post-intervention (up to 15 minutes)

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.

Acceptability of the intervention

Time Frame: At post-intervention (up to 15 minutes)

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.

Study Sites (1)

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