Clinical Trials Education Program for Hispanic Americans

Phase 3

Completed

• Conditions: Cancer

• Registration Number: NCT02083770
• Lead Sponsor: University of California, San Diego

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 Timeline

• Study Start: 2010-03
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-11
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1034

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to Second Follow-up	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 in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to First Follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Willingness to Participate in Research	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.

Trial Locations

Locations (1)

UC San Diego Moores Cancer Center; 🇺🇸 La Jolla, California, United States