Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trials Education Program for Hispanic Americans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02083770
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
San Diego State University
Information provided by (Responsible Party):
Georgia Robins Sadler, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE March 4, 2014
First Posted Date  ICMJE March 11, 2014
Last Update Posted Date March 4, 2020
Actual Study Start Date  ICMJE March 2010
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2016)
  • 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 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
  • Change from baseline in Participants' Attitudes and Beliefs Towards Clinical Trials [ Time Frame: Five minutes after receiving intervention ]
  • Change from baseline in Participants' Attitudes and Beliefs Towards Clinical Trials [ Time Frame: Three Months Post-intervention ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2014)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trials Education Program for Hispanic Americans
Official Title  ICMJE Randomized Controlled Clinical Trials Education Program for Hispanic Americans
Brief Summary 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Cancer Clinical Trials Education Program
  • 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.
    Intervention: Behavioral: Cancer Clinical Trials Education Program
Publications * Merz EL, Malcarne VL, Roesch SC, Riley N, Sadler GR. A multigroup confirmatory factor analysis of the Patient Health Questionnaire-9 among English- and Spanish-speaking Latinas. Cultur Divers Ethnic Minor Psychol. 2011 Jul;17(3):309-316. doi: 10.1037/a0023883.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2020)
1034
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2014)
1000
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02083770
Other Study ID Numbers  ICMJE CCT2525
NCI R25CA 130869 ( Other Identifier: UCSD )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Georgia Robins Sadler, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE San Diego State University
Investigators  ICMJE
Principal Investigator: Georgia R Sadler, PhD UC San Diego Moores Cancer Center
Principal Investigator: Vanessa L Malcarne, PhD San Diego State University
PRS Account University of California, San Diego
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP