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Completed

NCT Number: NCT02600533

Increasing Minority Participation in Clinical Trials

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.

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Key information

Conditions

Clinical Trial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt Ingram Cancer Center, Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: video group

Primary outcomes

  1. 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

  1. Clinical trial participation

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Meharry-Vanderbilt Alliance
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 9, 2015
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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