Clinical Trials Education Program for Hispanic Americans

March 3, 2020 updated by: Georgia Robins Sadler, University of California, San Diego

Randomized Controlled Clinical Trials Education Program for Hispanic Americans

Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test education programs designed to reduce barriers and Increase facilitators associated with cancer clinical trials participation for Hispanic Americans. Focus groups were conducted with Hispanic American men and women to obtain culturally-linked attitudes related to clinical trials participation. This information was used to create a prototypic educational program anticipated to increase participation in clinical trials. It was then vetted and honed via additional focus groups.

Simultaneously, a validation study was conducted with Hispanic Americans for a packet of psychosocial instruments that could be used for a subsequent randomized controlled trial to evaluate the impact of the clinical trials education program.

The finalized clinical trials education program was tested via a randomized controlled trial. Participants assigned to the experimental group received the clinical trials education program, while participants in the control arm were administered a comparable, but non-relevant education program. Recruitment to this study has been completed.

Study Type

Interventional

Enrollment (Actual)

1034

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093-0850
        • UC San Diego Moores Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Self-identified as Hispanic American
  • At least 21 years of age
  • Sufficiently literate to comprehend written and spoken testing materials in English or Spanish
  • Living in southern California
  • Mentally competent to complete the informed consenting process

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cancer Clinical Trials Education Program
Cancer Clinical Trials Education Program is offered to English- and Spanish-speaking Hispanics in the experimental arm. This program was designed to promote increased clinical trials literacy among Hispanic Americans. Increased clinical trials knowledge and a better understanding of clinical trials is anticipated to create more positive attitudes, and perceptions about clinical trials among Hispanic Americans.
Behavioral: Cancer Clinical Trials Education Program
Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.
Placebo Comparator: Neighborhood Watch Education Program
The Neighborhood Watch Program created by the Bureau of Justice Assistance and the National Crime Prevention Council was selected for inclusion in the control arm of this study. It provided participants with a program of equivalent length and format, as well as an equivalent focus on improving the well-being of Hispanic Americans. It also provided an opportunity to evaluate the impact of the Neighborhood Watch Program.
Behavioral: Cancer Clinical Trials Education Program
Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to First Follow-up
Time Frame: Change from baseline to first follow-up (immediately after receiving intervention)
To assess the impact of the intervention arm on participants' knowledge, attitudes, and perceptions related to clinical trials, they were asked to complete the same surveys given at baseline during post-intervention immediately after intervention.
Change from baseline to first follow-up (immediately after receiving intervention)
Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to Second Follow-up
Time Frame: Change from baseline to second follow-up (three months after receiving intervention)
At the three-month follow-up, participants were mailed the final packet of survey instruments to complete and return in a stamped, self-addressed envelope.
Change from baseline to second follow-up (three months after receiving intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Willingness to Participate in Research
Time Frame: Two weeks after receiving intervention
Two weeks after receiving the intervention, participants were mailed an invitation to participate in a different research study by a researcher not previously known to them, to assess whether the intervention influenced behavior related to clinical trials invitations.
Two weeks after receiving intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

San Diego State University

Investigators

  • Principal Investigator: Georgia R Sadler, PhD, UC San Diego Moores Cancer Center
  • Principal Investigator: Vanessa L Malcarne, PhD, San Diego State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2010

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CCT2525
  • NCI R25CA 130869 (Other Identifier: UCSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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