Increasing Minority Participation in Clinical Trials

NCT02600533 | Completed

• 2 other identifiers: 14117P30CA068485
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Trial

Keywords

minority group recruitment; stages of implementation; clinical trials education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical trial participation

  12 months

• Clinical trial knowledge survey

  7-10 days

• Likelihood to participate survey

  7-10 days

Study Arms (2)

Standard care/control group

NO INTERVENTION

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.

Video viewing group

EXPERIMENTAL

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

Interventions

Video viewing group PROCEDURE

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.

Also known as: video group

Video viewing group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous history of clinical trial research participation

Sponsors & Collaborators

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

Study Sites (1)

Vanderbilt Ingram Cancer Center, Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Study Officials

• Consuelo H. Wilkins, MD

  Meharry-Vanderbilt Alliance, Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director of the Meharry-Vanderbilt Alliance, Associate Professor

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 9, 2015
• Study Start: December 1, 2014
• Primary Completion: June 28, 2017
• Study Completion: June 28, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

US (1)