- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00310141
Computer-Assisted Counseling in Helping African American Smokers Stop Smoking
Treatment of Nicotine Dependence Among African Americans
RATIONALE: Stop-smoking plans using a nicotine patch, in-person counseling, and computer-assisted counseling may help people stop smoking.
PURPOSE: This randomized clinical trial is studying how well computer-assisted counseling helps African American smokers stop smoking.
연구 개요
상태
정황
상세 설명
OBJECTIVES:
- Develop and evaluate the efficacy of an interactive, culturally sensitive, individualized, palmtop computer-delivered smoking cessation intervention for African American smokers.
- Examine how hypothesized treatment mechanisms mediate the effects of computer-delivered treatment on abstinence.
OUTLINE: This is a randomized study. A subset of 20 participants are assigned to arm II for pilot testing. All other participants are randomized to 1 of 2 intervention arms.
- Arm I (standard care [SC]): Participants receive nicotine patch therapy on days -5 to 31. Participants also receive a Pathways to Freedom self-help guide and undergo 5 in-person counseling sessions based on the Treating Tobacco Use and Dependence Clinical Practice Guideline. The counseling sessions occur at 12 and 5 days prior to the quit smoking date and at 3, 10, and 31 days after the quit smoking date.
- Arm II (computer-delivered treatment [CDT]): Participants receive the same intervention as in arm I. Participants also undergo CDT for 6 weeks comprising 5 modules (quitting strategies; motivation and support; general smoking information; calendars and fun stuff; and daily tips) beginning 12 days prior to the quit smoking date and continuing for 31 days after the quit smoking date.
All participants complete questionnaires at baseline, during the counseling sessions, and then at approximately 6 months after the quit smoking date.
After completion of study intervention, participants are followed at approximately 6 months.
PROJECTED ACCRUAL: A total of 500 participants will be accrued for this study.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030-4009
- University of Texas MD Anderson Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- African American
- Age 21 to 65 years
- Current Smoker (history of at least 5 cigarettes/day for the last year)
- Motivated to quit within the next 14 days
- Participants must provide a viable home address and functioning home telephone number
- Can speak, read, write in English at a sixth-grade literacy level
- Provide viable collateral contact information
- Register "8" or more on a carbon monoxide breath test
Exclusion Criteria:
- Contraindication for nicotine patch use
- Active substance dependence (exclusive of nicotine dependence)
- Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless)
- Use of bupropion or nicotine products other than nicotine patches supplied by the study
- Pregnancy or lactation
- Any active illness that precludes full participation in the study protocol
- Another household member enrolled in the study
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 |
---|---|
활성 비교기: Standard Care Group
Written self-help materials, counseling, and 6-week nicotine patch supply
|
In-person counseling (5 sessions)
6-week supply of the nicotine patch
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활성 비교기: Computer Treatment Group (CDT)
Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment
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In-person counseling (5 sessions)
6-week supply of the nicotine patch
6 weeks of computer delivered treatment for quitting smoking
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실험적: CDT Pilot
Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment
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In-person counseling (5 sessions)
6-week supply of the nicotine patch
6 weeks of computer delivered treatment for quitting smoking
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment
기간: 6 months after treatment
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Abstinence measures are collected at four post cessation follow-up visits.
Point prevalence serving as the primary outcome measure.
Primary outcome analyses will use data from all of the follow-up visits.
SRNT Abstinence Status Questionnaire (Hughes et al., 2003) surveys the tobacco use by the participant and persons within the participant's household and social surroundings.
The questionnaire also collects data on the use of other tobacco products and nicotine replacement medications.
The pre- and post-quit versions of this questionnaire have been adapted to specific timepoints corresponding to participant visits.
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6 months after treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Contemplating smoking by Contemplation Ladder 6 months after treatment
기간: 6 months after treatment
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The Contemplation Ladder (Biener & Abrams, 1991) assesses readiness to quit smoking and ranges from 0-10 with 0 being "no thought of quitting" and 10 being "taking action to quit" (e.g., cutting down, enrolling in a program).
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6 months after treatment
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공동 작업자 및 조사자
수사관
- 연구 의자: David W. Wetter, PhD, MS, M.D. Anderson Cancer Center
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ID01-234
- P30CA016672 (미국 NIH 보조금/계약)
- R01CA094826 (미국 NIH 보조금/계약)
- MDA-ID-01234 (기타 식별자: UT MD Anderson Cancer Center)
- CDR0000466339 (레지스트리 식별자: NCI PDQ)
- NCI-2012-01637 (레지스트리 식별자: NCI CTRP)
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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