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OpenTrials
Completed

NCT Number: NCT06218615

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention (Video)

Other

Watch video

Other names: Fostering Opportunities in Research Using Marketing Strategies (FOR US)

Survey Administration

Other

Answer survey questions

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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