Increasing Minority Participation in Clinical Trials

Clinical Trial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600533
• Other study ID #: 14117
• Secondary ID: P30CA068485
• Status: Completed
• Phase: N/A
• First received: November 5, 2015
• Last updated: September 7, 2017
• Start date: December 2014
• Est. completion date: June 28, 2017

Study information

• Verified date: September 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 28, 2017
• Est. primary completion date: June 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clinical Trial

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt Ingram Cancer Center, Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Meharry-Vanderbilt Alliance, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	study feasibility	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.	12 months
Secondary	Clinical trial participation	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.	12 months
Secondary	Clinical trial knowledge survey	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).	7-10 days
Secondary	Likelihood to participate survey	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.	7-10 days