- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03115372
Lay Health Worker Outreach in Increasing Colorectal Cancer Screening in Asian Americans
The National Center for Reducing Asian American Cancer Health Disparities Research Project on Lay Health Workers and Asian Americans (AANCART)
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. Evaluate the efficacy of lay health worker (LHWs) outreach on colorectal cancer (CRC) screening among 3 Asian American groups (Filipinos, Hmong, and Koreans) in a cluster randomized controlled trial (RCT) comparing CRC education delivered by LHWs (intervention) to a CRC brochure and nutrition education (control).
II. Examine the processes through which LHWs communicate with, connect to, and convince community members from 3 Asian American cultures of the importance of CRC screening using mixed methods.
OUTLINE: Lay health workers (LHWs) are randomized to 1 of 2 groups.
GROUP I (CRC EDUCATION): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a CRC educational session conducted by an LHW over 90 minutes at month 1 and 3. Participants receive phone calls from the LHW at months 2 and 4 reminding them about CRC screening.
GROUP II (CRC BROCHURE): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a lecture on healthy nutrition for cardiovascular health presented by a professional health educator at months 1 and 3. After the first meeting, participants receive a brochure on CRC screening. Participants receive phone calls from the LHW at months 2 and 4 regarding changes in their nutritional behavior. Participants may attend an optional post-intervention LHW outreach session on CRC screening.
After completion of the study, patients are followed up at 2 months.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
California
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Los Angeles, California, 미국, 90095
- UCLA / Jonsson Comprehensive Cancer Center
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Sacramento, California, 미국, 95817
- University of California Davis Comprehensive Cancer Center
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San Francisco, California, 미국, 94115
- University of California, San Francisco
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Hawaii
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Honolulu, Hawaii, 미국, 96813
- University of Hawaii Cancer Center
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- LHW: self-identified as Filipino, Hmong, or Korean Americans
- LHW: age 18 or older
- LHW: are fluent in a Filipino language (Tagalog or Ilocano), Hmong, Korean, or English
- LHW: Live in the relevant area and intend to stay there for the next 12 months
- PARTICIPANTS: Self-identified as Filipino, Hmong, or Korean Americans
- PARTICIPANTS: speak a language that the LHW can speak such as Tagalog, Ilocano, Hmong, Korean, or English
- PARTICIPANTS: live in relevant area and intend to stay there for at least 12 months
- PARTICIPANTS: Are willing to participate in a study about health behaviors involving nutrition or CRC screening
Exclusion Criteria:
- Personal history of CRC
- Medical problems which may prevent them from attending 2 educational sessions
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Group I (CRC education)
LHWs undergo training over 3 days and recruit 15 participants from their social network.
Participants attend a CRC educational session conducted by an LHW over 90 minutes at month 1 and 3. Participants receive phone calls from the LHW at months 2 and 4 reminding them about CRC screening.
|
보조 연구
Attend CRC education session
다른 이름들:
Attend healthy nutrition session
다른 이름들:
Receive telephone reminder about CRC screening
Receive telephone reminder about healthy nutrition
|
|
활성 비교기: Group II (CRC brochure)
LHWs undergo training over 3 days and recruit 15 participants from their social network.
Participants attend a lecture on healthy nutrition for cardiovascular health presented by a professional health educator at months 1 and 3.
After the first meeting, participants receive a brochure on CRC screening.
Participants receive phone calls from the LHW at months 2 and 4 regarding changes in their nutritional behavior.
Participants may attend an optional post-intervention LHW outreach session on CRC screening.
|
보조 연구
Attend CRC education session
다른 이름들:
Attend healthy nutrition session
다른 이름들:
Receive telephone reminder about CRC screening
Receive telephone reminder about healthy nutrition
Receive CRC screening brochure
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of participants who report ever having had a CRC screening test
기간: Baseline to 6 months
|
Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention.
A linear model with identity link function will be used with group (intervention or control), time (pre- or post-), and group-by-time interaction to test for a difference in the change from pre- to post-intervention between the 2 groups, thus measuring the efficacy of the intervention.
|
Baseline to 6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of participants who are up-to-date for CRC screening
기간: At 6 months
|
Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention.
|
At 6 months
|
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Proportion of participants who intend to obtain CRC screening in the next 6 months
기간: At 6 months
|
Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention.
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At 6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Tung Nguyen, University of California, San Francisco
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 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 11056 (DAIDS ES Registry Number)
- U54CA153499 (미국 NIH 보조금/계약)
- NCI-2017-00515 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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