Cancer
Conditions
Keywords
Hispanics, Patient Participation, Refusal to Participate, Education, Clinical Trials
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.
Interventions
BEHAVIORALCancer 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.
Sponsors
San Diego State University
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to First Follow-up | 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. |
| Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to Second Follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Willingness to Participate in Research | Two weeks after receiving intervention | 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. |
Countries
United States
Outcome results
None listed