Increasing Minority Participation in Clinical Trials

Not Applicable

Completed

• Conditions: Clinical Trial

• Registration Number: NCT02600533
• Lead Sponsor: Vanderbilt University Medical Center

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Primary Completion: 2017-06-28
• Study Completion: 2017-06-28
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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).
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.

Trial Locations

Locations (1)

Vanderbilt Ingram Cancer Center, Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States