Expanding Clinical Trial Awareness Among Black Communities Through Digital Engagement

NCT06218615 | Completed

• 3 other identifiers: RG1124067NCI-2024-00180FHIRB0020288
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (1)

Health Services Research

EXPERIMENTAL

Participants watch a culturally tailored decision aid video. Surveys are completed before and after the video.

Other: Educational Intervention (Video); Other: Survey Administration

Interventions

Educational Intervention (Video) OTHER

Watch video

Also known as: Fostering Opportunities in Research Using Marketing Strategies (FOR US)

Health Services Research

Survey Administration OTHER

Answer survey questions

Health Services Research

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Vida Henderson

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: June 6, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)