Einführung einer Tabakbehandlung in Low-Dose-CT-Lungenkrebs-Screening-Sites
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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
-
-
California
-
Los Angeles, California, Vereinigte Staaten, 90033
- University of Southern California (Data Collection Only)
-
Walnut Creek, California, Vereinigte Staaten, 94598
- John Muir Health
-
-
Georgia
-
La Grange, Georgia, Vereinigte Staaten, 30240
- WellStar Health System
-
-
Illinois
-
Chicago, Illinois, Vereinigte Staaten, 606012
- Rush University Medical Center
-
Kankakee, Illinois, Vereinigte Staaten, 60901
- Riverside Healthcare
-
-
Indiana
-
Crown Point, Indiana, Vereinigte Staaten, 46307
- St. Mary Medical Center, Community Healthcare System
-
-
Iowa
-
Des Moines, Iowa, Vereinigte Staaten, 50314
- MercyOne Des Moines Medical Center (Data Collection Only)
-
-
Maine
-
Scarborough, Maine, Vereinigte Staaten, 04074
- Maine Medical Center Cancer Institute
-
-
Michigan
-
Detroit, Michigan, Vereinigte Staaten, 48202
- Henry Ford Hospital (Data collection only)
-
Traverse City, Michigan, Vereinigte Staaten, 49684
- Munson Healthcare
-
-
New York
-
Mineola, New York, Vereinigte Staaten, 11501
- NYU Winthrop Hospital
-
New York, New York, Vereinigte Staaten, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, Vereinigte Staaten, 10065
- Weill Cornell Medical Center
-
The Bronx, New York, Vereinigte Staaten, 10467
- Montefiore Medical Center (Data Collection Only)
-
-
North Carolina
-
Morganton, North Carolina, Vereinigte Staaten, 28655
- Carolinas Healthcare System Blue Ridge
-
-
Ohio
-
Lancaster, Ohio, Vereinigte Staaten, 43130
- Fairfield Medical Center
-
-
Oregon
-
Portland, Oregon, Vereinigte Staaten, 97210
- Legacy Health
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Vereinigte Staaten, 19140
- Temple University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Fakultätszuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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 |
|
Experimental: 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 |
|
Experimental: 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 |
|
Experimental: 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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
number of patients who are tobacco abstinence
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Jamie Ostroff, PhD, Memorial Sloan Kettering Cancer Center
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Verhalten
- Gesundheitsverhalten
- Raucherentwöhnung
- Therapeutika
- Arzneimitteltherapie
- Gesundheitsdienste
- Belegschaft und Dienstleistungen für Gesundheitseinrichtungen
- Verhaltensdisziplinen und Aktivitäten
- Richtlinienberatung
- Beratung
- Psychiatrische Dienste
- Motivationsinterviews
- Tabakkonsumsteuergeräte
- Nikotinersatztherapie
Andere Studien-ID-Nummern
- 17-500
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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