Clinical Trials Education Program for Hispanic Americans

Cancer Clinical Trial

Official title:

Randomized Controlled Clinical Trials Education Program for Hispanic Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083770
• Other study ID #: CCT2525
• Secondary ID: NCI R25CA 130869
• Status: Completed
• Phase: Phase 3
• Start date: March 2010
• Est. completion date: August 2018

Study information

• Verified date: March 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1034
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	UC San Diego Moores Cancer Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	San Diego State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to First Follow-up	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.	Change from baseline to first follow-up (immediately after receiving intervention)
Primary	Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to Second Follow-up	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 from baseline to second follow-up (three months after receiving intervention)
Secondary	Willingness to Participate in Research	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.	Two weeks after receiving intervention