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CompletedNCT06218615Updated Jul 23, 2024

Expanding Clinical Trial Awareness Among Black Communities Through Digital Engagement

An interventional study of Educational Intervention (Video) and Survey Administration in Cancer, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by Fred Hutchinson Cancer Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
109
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cancer

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In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 109 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.

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Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 546 studies on the registry; 79 are open to participants now.

Of its 59 completed or terminated interventional studies of FDA-regulated products, 46 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
109 participants (actual)

Study arms

  • Experimental
    Health Services Research

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

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

Interventions

  • OtherEducational Intervention (Video)

    Watch video

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

  • OtherSurvey Administration

    Answer survey questions

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What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

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Study locations

1 site
  • Fred Hutch/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
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References and documents

Study documents

  • Informed consent form · Nov 16, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06218615
Responsible party
Sponsor
First posted
Jan 23, 2024
Start date
Jun 6, 2024
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024
Last update
Jul 23, 2024

Study contacts

Vida Henderson
principal investigator · Fred Hutch/University of Washington Cancer Consortium

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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