FDNY의 금연
FDNY에서 금연을 통한 폐암 예방
At the Fire Department of the City of New York (FDNY) World Trade Center Health Program, 36% of participants in the low dose computed tomography (LDCT) lung cancer screening program are current smokers, despite referral to the free FDNY Tobacco Cessation Program (Standard Care). Investigators propose testing an Enhanced Care program which includes opt-out enrollment; tobacco cessation counseling will be individually tailored to spirometry/LDCT results and treatment with varenicline starting 4 weeks prior to their target quit date. This randomized trial will compare enrollment and cessation outcomes in Standard Care vs. Enhanced Care groups of challenging-to-treat, high-risk smokers.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The overarching goal of this Randomized Controlled trial is to develop and test an effective, scalable intervention with potential to reach high-risk smokers undergoing CT lung cancer screening who have not engaged in or succeeded with traditional tobacco treatment approaches. The investigators will test an Enhanced Care intervention specifically designed to address multiple challenges to tobacco treatment engagement and success. First, the researchers will test opt-out enrollment in cessation treatment. The current tobacco treatment default, in which patients must opt-in to cessation treatment and are only offered counseling and pharmacotherapy when deemed ready to quit, results in missed opportunities to engage smokers into treatment. Previous studies of opt-out enrollment in cessation treatment suggest that an opt-out tobacco treatment strategy substantially increases engagement and cessation rates compared with traditional opt-in approaches. Second, proactive counseling will leverage the "reachable, teachable moment" of CT screening to motivate cessation through individually tailored messaging tied to CT results and lung function spirometry. Using CT results as a motivational tool has shown promise in pilot studies. The optimal approach and success of using CT coupled with spirometry results to motivate tobacco cessation remains unknown. Third, investigators will offer varenicline pre-loading to all enrollees, regardless of study arm, in which varenicline is initiated 4 weeks prior to target quit date. This approach is associated with decreased pre-quit tobacco-associated reward and double the rate of abstinence compared with standard varenicline treatment.
The investigators thus propose a randomized trial among retired FDNY World Trade Center Health Program responders eligible for the FDNY World Trade Center Health Program CT screening program to test the effects of Enhanced Care (opt-out enrollment, tailored counseling based on CT and spirometry results, and varenicline with preloading) against Standard Care (opt-in enrollment, standard cessation counseling without spirometry/CT tailoring, and varenicline with preloading) in the engagement of high-risk smokers in cessation treatment and the achievement of tobacco abstinence.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 4단계
연락처 및 위치
연구 장소
-
-
New York
-
Brooklyn, New York, 미국, 11201
- FDNY World Trade Center Health Program
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria
- Enrolled in FDNY World Trade Center Health Program (WTCHP)
- Retired
- Age ≥ 50 years old
- Self-reported current smoker on most recent questionnaire OR self-reported current smoker in the past 5 years
- 20 pack-year smoker OR 20-year smoking duration
Exclusion Criteria
- Reduced renal function
- estimated glomerular filtration rate (eGFR) <30 [CKD-EPI Creatinine Equation (2021)] at last World Trade Center (WTC) medical monitoring blood exam OR ICD10 codes for kidney disease: N04.9, N17.9, N18.9, Z94.0, E13.21, N18.9, I12.9, N00.9, N03.9
- Undergoing active cancer treatment, defined as being diagnosed on 1/1/2022 or later
- Clinical instability (e.g., hospitalization in last 3 months)
- Using varenicline in last 30 days
- Endorsing suicidal ideations: moderate or high risk on Columbia-Suicide Severity Rating Scale (C-SSRS)
- Screened for alcohol use disorder AUDIT>15
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Enhanced Care
Opt-out counseling enrollment. individually-tailored biofeedback linked to Chest CT and spirometry results. Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28. 1 mg twice day for 12 weeks after target quit date. |
Participants automatically enrolled in motivational counseling. Tailored counseling includes sharing results of Chest CT results and lung function spirometry tests with participants. |
|
활성 비교기: Standard Care
Opt-in counseling enrollment. Standard tobacco cessation counseling. Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28. 1 mg twice day for 12 weeks after target quit date. |
Participants must opt-in to receive counseling. Counseling does not include discussion of Chest CT or spirometry results. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Enrollment
기간: Baseline (Week 0)
|
Enrollment is defined as all participants who completed at least one session with our tobacco treatment specialist in FDNY's Tobacco Cessation Program: Standard vs. Enhanced Care arms. The number of participants who attend at least one study visit with the tobacco treatment specialist from the eligible recruitment population will be tabulated and reported. |
Baseline (Week 0)
|
|
Number of Participants With (Biochemically Validated) Tobacco Abstinence
기간: Weeks 2, 4, 8, 12, and 16 along with a 12-week post end of treatment (EOT) timepoint visit at 28 weeks
|
7-day point prevalence abstinence will be biochemically verified by the analysis of urine samples collected at a laboratory nearest each participant's residence. Urine sample collection will occur at weeks 2, 4, 8, 12, and 16 along with a 12-week post end of treatment (EOT) timepoint at 28 weeks. Samples will be analyzed for urine cotinine which is the commonly measured biomarker of nicotine intake. Urine cotinine levels < 20 ng/mL will be used to verify tobacco abstinence. Data will be summarized at each timepoint by study arm from weeks 2 - weeks 28 using basic descriptive statistics at each research assessment visit. |
Weeks 2, 4, 8, 12, and 16 along with a 12-week post end of treatment (EOT) timepoint visit at 28 weeks
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Retention to Study End-Date
기간: Through the 12-week post EOT timepoint at 28 weeks
|
Retention will be assessed and reported as the number of participants retained in the study through the time of the 12-week post end of treatment (EOT) timepoint at 28 weeks. |
Through the 12-week post EOT timepoint at 28 weeks
|
|
Number of Participants Who Attended Counseling Visit at Each Timepoint - Counseling Adherence
기간: Baseline, Weeks 2, 4, 8, 12, 16, and the 12-week post EOT timepoint visit at 28 weeks
|
Counseling adherence will be determined by the number of counseling visits attended. Tobacco counseling sessions will occur at baseline, and at weeks 2, 4, 8, 12, and 16 along with a 12-week post end of treatment (EOT) timepoint at 28 weeks. Counseling adherence will be summarized by study arm based on attendance during each individual session (timepoint) and reported as a continuous variable for each timepoint (counseling visit). |
Baseline, Weeks 2, 4, 8, 12, 16, and the 12-week post EOT timepoint visit at 28 weeks
|
|
Pill Count Percentage - Varenicline Adherence
기간: Baseline, Weeks 2, 4, 8, 12, and 16
|
Varenicline adherence will be measured using pill count percentage, recorded as the number of pills taken divided by the number of pills prescribed, per participant, corresponding to the dosing regimen. Varenicline adherence data will be summarized by study arm using basic descriptive statistics for each week of treatment. Participants refusing medication will be counted as zero. Participants discontinuing medication due to reported side effects or adverse events will be excluded from calculation totals. Medication adherence rates in excess of 100% (e.g., subjects mistakenly took extra pills) will be reported as 100% adherence. Similarly, medication adherence rates below zero (e.g., subjects added pills to the bottle but did not remove any pills) will be reported as 0% adherence. Pill count adherence is an objective measure that has been shown to correlate with electronic monitors and varenicline plasma levels. |
Baseline, Weeks 2, 4, 8, 12, and 16
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Shadi Nahvi, MD, MS, Albert Einstein College of Medicine
- 수석 연구원: David Goldfarb, PhD, FDNY
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2023-14980
- R21OH012256 (미국 NIH 보조금/계약)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The datasets generated and analyzed during the current study are not publicly available, but a deidentified dataset may be available from the principal investigator upon reasonable request.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .