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Clinical Trials/NCT02600533
NCT02600533
Completed
Not Applicable

Increasing Minority Group Participation in Clinical Trials a Randomized Controlled Study of an Office-based Educational Video

Vanderbilt University Medical Center1 site in 1 country63 target enrollmentDecember 2014
ConditionsClinical Trial

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Clinical Trial
Sponsor
Vanderbilt University Medical Center
Enrollment
63
Locations
1
Primary Endpoint
study feasibility
Status
Completed
Last Updated
8 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
June 28, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Consuelo H Wilkins

Executive Director of the Meharry-Vanderbilt Alliance, Associate Professor

Vanderbilt University Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

study feasibility

Time Frame: 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 Outcomes

  • Clinical trial participation(12 months)
  • Clinical trial knowledge survey(7-10 days)
  • Likelihood to participate survey(7-10 days)

Study Sites (1)

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