Expanding Clinical Trial Awareness Among Black Communities Through Digital Engagement

Cancer Clinical Trial

Official title:

Expanding Clinical Trial Awareness Among Black Communities Through Digital Engagement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218615
• Other study ID #: RG1124067
• Secondary ID: NCI-2024-00180FH
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Ashley McDonald
• Phone: 510-468-5319
• Email: amcdona4[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Educational Intervention (Video)
Watch video
• Survey Administration
Answer survey questions

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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