- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02083770
Clinical Trials Education Program for Hispanic Americans
Randomized Controlled Clinical Trials Education Program for Hispanic Americans
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
California
-
La Jolla, California, 미국, 92093-0850
- UC San Diego Moores Cancer Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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:
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Cancer Clinical Trials Education Program
Cancer Clinical Trials Education Program is offered to English- and Spanish-speaking Hispanics in the experimental arm.
This program was designed to promote increased clinical trials literacy among Hispanic Americans.
Increased clinical trials knowledge and a better understanding of clinical trials is anticipated to create more positive attitudes, and perceptions about clinical trials among Hispanic Americans.
|
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.
|
|
위약 비교기: Neighborhood Watch Education Program
The Neighborhood Watch Program created by the Bureau of Justice Assistance and the National Crime Prevention Council was selected for inclusion in the control arm of this study.
It provided participants with a program of equivalent length and format, as well as an equivalent focus on improving the well-being of Hispanic Americans.
It also provided an opportunity to evaluate the impact of the Neighborhood Watch 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to First Follow-up
기간: 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 from baseline to first follow-up (immediately after receiving intervention)
|
|
Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to Second Follow-up
기간: 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 from baseline to second follow-up (three months after receiving intervention)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Willingness to Participate in Research
기간: 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.
|
Two weeks after receiving intervention
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Georgia R Sadler, PhD, UC San Diego Moores Cancer Center
- 수석 연구원: Vanessa L Malcarne, PhD, San Diego State University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .