Clinical trial NCT02083770: Clinical Trials Education Program for Hispanic Americans
Official title: Randomized Controlled Clinical Trials Education Program for Hispanic Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: Hispanics
Patient Participation
Refusal to Participate
Education
Clinical Trials
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Diego State University
First posted: 2014-03-11
Enrollment: 1034
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to First Follow-up
timeFrame: Change from baseline to first follow-up (immediately after receiving intervention)
measure: Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to Second Follow-up
timeFrame: Change from baseline to second follow-up (three months after receiving intervention)
Secondary outcomes:
measure: Willingness to Participate in Research
timeFrame: Two weeks after receiving intervention
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
Study officials:
affiliation: UC San Diego Moores Cancer Center
name: Georgia R Sadler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Vanessa L Malcarne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.