Randomized Controlled Clinical Trials Education Program for Hispanic Americans
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,034
- Locations
- 1
- Primary Endpoint
- Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to Second Follow-up
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Health Services Research
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Not provided
Arms & Interventions
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: Cancer Clinical Trials Education Program (Behavioral)
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: Cancer Clinical Trials Education Program (Behavioral)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Willingness to Participate in Research(Two weeks after receiving intervention)
Investigators
Georgia Robins Sadler
Professor
University of California, San Diego