저선량 CT 폐암 검진 부위에서 담배 치료 시행
This study is to help determine the most effective type or combination of treatments to offer patients seeking lung cancer screening who are smokers to help them reduce the number of cigarettes they smoke, or quit smoking. The investigators long term goal is to increase the benefits of lung cancer screening by providing a blue print of best practices for screening sites to deliver tobacco treatment to their patients who are smokers, in a way that does not add burden to screening site staff and increases the chances of patients quitting smoking.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90033
- University of Southern California (Data Collection Only)
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Walnut Creek, California, 미국, 94598
- John Muir Health
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Georgia
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La Grange, Georgia, 미국, 30240
- WellStar Health System
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Illinois
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Chicago, Illinois, 미국, 606012
- Rush University Medical Center
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Kankakee, Illinois, 미국, 60901
- Riverside Healthcare
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Indiana
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Crown Point, Indiana, 미국, 46307
- St. Mary Medical Center, Community Healthcare System
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Iowa
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Des Moines, Iowa, 미국, 50314
- MercyOne Des Moines Medical Center (Data Collection Only)
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Maine
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Scarborough, Maine, 미국, 04074
- Maine Medical Center Cancer Institute
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Michigan
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Detroit, Michigan, 미국, 48202
- Henry Ford Hospital (Data collection only)
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Traverse City, Michigan, 미국, 49684
- Munson Healthcare
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New York
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Mineola, New York, 미국, 11501
- NYU Winthrop Hospital
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New York, New York, 미국, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, 미국, 10065
- Weill Cornell Medical Center
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The Bronx, New York, 미국, 10467
- Montefiore Medical Center (Data Collection Only)
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North Carolina
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Morganton, North Carolina, 미국, 28655
- Carolinas Healthcare System Blue Ridge
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Ohio
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Lancaster, Ohio, 미국, 43130
- Fairfield Medical Center
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Oregon
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Portland, Oregon, 미국, 97210
- Legacy Health
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19140
- Temple University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Site Eligibility (as per SC self-report)
& Must be designated as an American College of Radiology (ACR) designated lung cancer screening site
- Reports at least one year of lung cancer screening experience
- Reports conducting at least 20 new initial screenings per month Site Coordinator (SC) Eligibility (as per SC self-report)
- Employed as a full-time Site Coordinator at participating lung cancer screening site Patient Eligibility (as per self-report)
- Between the ages of 50-80 years old
- Seeking baseline or annual follow-up LDCT lung cancer screening
- Have at least a 20 pack-year history of smoking
- Currently a smoker, defined as self-reported cigarette smoking (some days, every day) within the past 30 days.
- Must be reachable by telephone
- Must be English or Spanish speaking due to the study materials being available in only these languages and limited available resources for translation.
Exclusion Criteria:
Patient (as per self-report)
- NRT is medically contraindicated (e.g., recent heart attack within the last 2 weeks or, unstable/worsening angina).
- Smokers who are receiving other tobacco treatment services or have used cessation medications (NRT, bupropion, varenicline) within the past month.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Motivational Interviewing( MI) (Yes vs. No)
Participants will receive two motivational informed cessation sessions; the first delivered face to faceor via telephone by the SC during the patient's initial lung cancer screening visit or during the shared decision making discussion or within about 1 week following their screening visit, and the second session delivered by telephone by the SC approximately 4 to 8 weeks after the first MI session. |
two counseling sessions saliva samples from those reporting abstinence and analyze samples |
|
실험적: Nicotine Replacement Therapy (NRT) Patch (Yes vs. No)
Participants will receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day and written instructions to use the patch daily starting on date they mutually agreed upon with their site coordinator. Participants who smoke fewer than 10 cigarettes per day will receive 4-weeks of the 14mg patch (2 boxes), and 2-weeks of the 7mg patch (1 box). Those who smoke 10 or more cigarettes per day will receive 4-weeks of the 21mg patch (2 boxes) and 2-weeks of the 14mg patch (1 box). Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion & Fulfillment. |
saliva samples from those reporting abstinence and analyze samples receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day |
|
실험적: NRT Lozenge (Yes vs. No)
Participants will receive will receive 6 packs of NRT 2mg lozenge and written instructions to use the lozenge PRN to help manage acute nicotine withdrawal. Participants will be instructed to use the NRT lozenges no more than every 1-2 hours as needed. Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion & Fulfillment. |
saliva samples from those reporting abstinence and analyze samples 6 packs of NRT 2mg lozenge |
|
실험적: Message Framing (Gain vs. Loss)
Overall, a robust body of health communication literature demonstrates that gain-framed messages may be more effective than loss-framed or non-framed (neutral) messages for encouraging smoking cessation. In other words, quitting messages that promote smoking cessation are more persuasive if they emphasize the benefits of quitting (gain-framed) rather than the risks (loss-framed) of persistent smoking (25, 26). Included with the written communication of their LDCT-LCS results, participants will receive a printed individualized quitting message that emphasizes either the benefits of quitting (gain-framed) or the risks of continuing to smoke (loss-framed). |
saliva samples from those reporting abstinence and analyze samples health communication literature and quitting messages |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
number of patients who are tobacco abstinence
기간: 6 months following study enrollment
|
biochemical verification of smoking abstinence will be conducted Consistent with Intent to Treat, unless self reported smoking abstinence is biochemically verified, (<3 ng/ml for mailed salivary cotinine assay) for participants who fail to return the saliva sample, the cessation outcome will be considered non-abstinent. |
6 months following study enrollment
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jamie Ostroff, PhD, Memorial Sloan Kettering Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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 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. .