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Clinical Trials Education Program for Hispanic Americans and Asian Pacific Islanders

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, San Diego
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: June 9, 2014
Last verified: June 2014
  Purpose

Hispanic Americans and Asian/Pacific Islanders 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 and Pacific Islanders.


Condition Intervention Phase
Education Activities
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 and Asian Pacific Islanders

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Participants' Baseline Knowledge, Attitudes and Beliefs Related to Clinical Trials [ Time Frame: Baseline data was collected prior to randomization to study arm. ] [ Designated as safety issue: No ]
    To gain descriptive data related to the participants' baseline knowledge, attitudes, and beliefs related to clinical trials, they were ask to complete a pre-intervention packet of surveys. These data were collected immediately after participants were consented. Following baseline data collection, they were then immediately randomized to participate in either the intervention or control arm.

  • Post-Intervention Changes in Participants' Clinical Trials-Related Knowledge, Attitudes, and Beliefs [ Time Frame: 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 post-intervention.

  • Longer Term Retention of Participants' Gains in Clinical Trials-Related Knowledge, Attitudes, and Beliefs at Three Months [ Time Frame: Three months after receiving intervention ] [ Designated as safety issue: No ]
    At three months, 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.


Estimated Enrollment: 950
Study Start Date: March 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Education Program
Cancer Clinical Trial Education Program
Behavioral: Cancer Clinical Trials Education Program
Placebo Comparator: Neighborhood Watch
Education about neighborhood watch Programs

Detailed Description:

Hispanic Americans and Asian/Pacific Islanders 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 and Asian/Pacific Islanders. 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.

A comparable approach is being used to develop a program(s) for Asian/Pacific Islanders. Recruitment to the focus groups is still underway.

  Eligibility

Ages Eligible for Study:   21 Years and older
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

Contacts
Contact: Miguel A Martin del Campo, MA 8588225760 mam087@ucsd.edu

Locations
United States, California
UCSD Moore's Cancer Center Recruiting
La Jolla, California, United States, 92093-0850
Contact: Martin del Campo       mam087@ucsd.edu   
Contact: Georgia R Sadler, MBA, PhD    8585347611    gsadler@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
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: June 9, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 21, 2014