Clinical Trials Education Program for Hispanic Americans

University of California San Diego

Status and phase: Completed; Phase 3

Conditions: Cancer

Treatments: Behavioral: Cancer Clinical Trials Education Program

Study type: Interventional

Funder types: Other

Identifiers

NCT02083770

NCI R25CA 130869 (Other Identifier)

CCT2525

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,034 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

---

1,034 participants in 2 patient groups, including a placebo group

Cancer Clinical Trials Education Program

Experimental group

Description:

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.

Treatment:

Behavioral: Cancer Clinical Trials Education Program

Neighborhood Watch Education Program

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Cancer Clinical Trials Education Program