Randomized Controlled Clinical Trials Education Program for Hispanic Americans
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- University of California, San Diego
- Enrollment
- 1034
- Locations
- 1
- Primary Endpoint
- Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to Second Follow-up
- Status
- Completed
- Last Updated
- 6 years ago
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.
Investigators
Georgia Robins Sadler
Professor
University of California, San Diego
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
- Not provided
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)