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Clinical Trials Education Program for Hispanic Americans

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
San Diego State University
Information provided by (Responsible Party):
Georgia Robins Sadler, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT02083770
First received: March 4, 2014
Last updated: May 6, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Cancer
Behavioral: Cancer Clinical Trials Education Program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Randomized Controlled Clinical Trials Education Program for Hispanic Americans

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Willingness to Participate in Research [ Time Frame: Two weeks after receiving intervention ] [ Designated as safety issue: No ]
    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.


Enrollment: 956
Study Start Date: March 2010
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02083770

Locations
United States, California
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093-0850
Sponsors and Collaborators
University of California, San Diego
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
  More Information

Publications:
Responsible Party: Georgia Robins Sadler, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02083770     History of Changes
Other Study ID Numbers: CCT2525  NCI R25CA 130869 
Study First Received: March 4, 2014
Last Updated: May 6, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of California, San Diego:
Hispanics
Patient Participation
Refusal to Participate
Education
Clinical Trials

ClinicalTrials.gov processed this record on December 07, 2016