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Increasing Minority Participation in Clinical Trials

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02600533
Collaborator
National Cancer Institute (NCI) (NIH), Meharry-Vanderbilt Alliance (Other)
63
Enrollment
1
Location
2
Arms
30.9
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation. This study will also determine the feasibility of implementing an office-based video educational program.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Video viewing group
 N/A

Detailed Description

Clinical trials are essential to scientific discovery and are critical to translating research in to practice. Despite their significance, clinical trial participation rates remain low, especially among underrepresented minority groups. Several barriers exist to minority group participation in clinical trial, one of which lack of awareness about clinical trials. Video educational programs show promise as an effective strategy to increase knowledge and clinical trial participation. The specific aims are as follows:

  1. Measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation.

  2. Determine the feasibility of implementing an office-based video educational program.

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Increasing Minority Group Participation in Clinical Trials a Randomized Controlled Study of an Office-based Educational Video
Actual Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Jun 28, 2017
Actual Study Completion Date :
Jun 28, 2017

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard care/control group

First, participants will complete a brief electronic survey measuring their opinions on clinical trials. Next, participants in the standard of care group will be provided standard educational resources (booklet and DVD), with no additional instructions. Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research.
Experimental: Video viewing group

First, participants will complete a brief electronic survey measuring their opinions on clinical trials. Next, participants in the video viewing group will watch the 10-minute DVD video on tablet devices using headphones in the clinic. Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research.

Procedure: Video viewing group
First, participants will complete a brief electronic survey measuring their opinions on clinical trials. Next, participants in the video viewing group will watch the 10-minute DVD video on tablet devices using headphones in the clinic. Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research.
Other Names:
  • video group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. study feasibility [12 months]

      The stages of implementation completion (SIC) measure will be used as an internal tool utilized by the study team to track time to achievement of key implementation milestones. An 8-stage implementation plan to measure feasibility of the office-based educational program will be executed across 3 phases. Three scores will be derived from the SIC measure. The first score is the number of stages completed. The second score is the time spent at each stage. The third score is the proportion of activities completed at each stage. Implementation of the SIC model poses no additional burden on study participants.

    Secondary Outcome Measures

    1. Clinical trial participation [12 months]

      Information on clinical trial participation will be collected by a team member by reviewing the participants' health record and by contacting the VICC clinical trial team.

    2. Clinical trial knowledge survey [7-10 days]

      This survey consist of 22-items assessing a participants views on clinical trials on 5 domains (positive beliefs, safety, information needs, negative expectations, and patient involvement).

    3. Likelihood to participate survey [7-10 days]

      This survey consist of 5-items assessing reasons for not participating in research, views about sources of research, views about sharing of research data, trust, and willingness to advise research teams.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Participants will be patients of Vanderbilt-Ingram Cancer Center (VICC) with a diagnosis of cancer Participants will have no previous history of clinical trial research participation

    Exclusion Criteria:
    • Previous history of clinical trial research participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanderbilt Ingram Cancer Center, Vanderbilt University Medical Center Nashville Tennessee United States 37232

    Sponsors and Collaborators

    • Vanderbilt University Medical Center
    • National Cancer Institute (NCI)
    • Meharry-Vanderbilt Alliance

    Investigators

    • Principal Investigator: Consuelo H. Wilkins, MD, Meharry-Vanderbilt Alliance, Vanderbilt University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Consuelo H Wilkins, Executive Director of the Meharry-Vanderbilt Alliance, Associate Professor, Vanderbilt University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02600533
    Other Study ID Numbers:
    • 14117
    • P30CA068485
    First Posted:
    Nov 9, 2015
    Last Update Posted:
    Sep 11, 2017
    Last Verified:
    Sep 1, 2017
    Keywords provided by Consuelo H Wilkins, Executive Director of the Meharry-Vanderbilt Alliance, Associate Professor, Vanderbilt University Medical Center
    minority group recruitment
    stages of implementation
    clinical trials education

    Study Results

    No Results Posted as of Sep 11, 2017