Clinical Trials Education Program for Hispanic Americans and Asian Pacific Islanders
Behavioral: Cancer Clinical Trials Education Program
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||Randomized Controlled Clinical Trials Education Program for Hispanic Americans and Asian Pacific Islanders|
- Participants' Baseline Knowledge, Attitudes and Beliefs Related to Clinical Trials [ Time Frame: Baseline data was collected prior to randomization to study arm. ] [ Designated as safety issue: No ]To gain descriptive data related to the participants' baseline knowledge, attitudes, and beliefs related to clinical trials, they were ask to complete a pre-intervention packet of surveys. These data were collected immediately after participants were consented. Following baseline data collection, they were then immediately randomized to participate in either the intervention or control arm.
- Post-Intervention Changes in Participants' Clinical Trials-Related Knowledge, Attitudes, and Beliefs [ Time Frame: Immediately after receiving intervention ] [ Designated as safety issue: No ]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 post-intervention.
- Longer Term Retention of Participants' Gains in Clinical Trials-Related Knowledge, Attitudes, and Beliefs at Three Months [ Time Frame: Three months after receiving intervention ] [ Designated as safety issue: No ]At three months, participants were mailed the final packet of survey instruments to complete and return in a stamped, self-addressed envelope.
- Willingness to Participate in Research [ Time Frame: Two weeks after receiving intervention ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Education Program
Cancer Clinical Trial Education Program
|Behavioral: Cancer Clinical Trials Education Program|
Placebo Comparator: Neighborhood Watch
Education about neighborhood watch Programs
Hispanic Americans and Asian/Pacific Islanders 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 and Asian/Pacific Islanders. 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.
A comparable approach is being used to develop a program(s) for Asian/Pacific Islanders. Recruitment to the focus groups is still underway.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02083770
|Contact: Miguel A Martin del Campo, MAfirstname.lastname@example.org|
|United States, California|
|UCSD Moore's Cancer Center||Recruiting|
|La Jolla, California, United States, 92093-0850|
|Contact: Martin del Campo email@example.com|
|Contact: Georgia R Sadler, MBA, PhD 8585347611 firstname.lastname@example.org|