Overview

This trial is active, not recruiting.

Condition cancer
Treatment cancer clinical trials education program
Phase phase 3
Sponsor University of California, San Diego
Collaborator San Diego State University
Start date March 2010
End date December 2015
Trial size 956 participants
Trial identifier NCT02083770, CCT2525, NCI R25CA 130869

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.

United States No locations recruiting
Other Countries No locations recruiting

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
Arm
(Experimental)
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.
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)
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.
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.

Primary Outcomes

Measure
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)
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)

Secondary Outcomes

Measure
Willingness to Participate in Research
time frame: Two weeks after receiving intervention

Eligibility Criteria

Male or female participants at least 21 years old.

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:

Additional Information

Official title Randomized Controlled Clinical Trials Education Program for Hispanic Americans
Principal investigator Georgia R Sadler, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of California, San Diego.