- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07857681
Text Message and Mail Delivery of Tailored Educational Materials to Improve Access to Resources for Smoking Cessation of Menthol Tobacco Cigarettes
An Exploratory Investigation on Effectiveness of Tailored New York State Quitline Services for Cessation of Menthol Tobacco Cigarettes
This clinical trial compares the impact of receiving educational materials containing relevant content about risks from smoking menthol cigarettes which include links to the New York (NY) Smoke-Free website by text message or mail in people who smoke menthol cigarettes. The NY Smoke-Free website includes tailored content developed specifically for menthol smokers and provides resources designed to resonate with the experiences of menthol smokers and address the unique challenges they face in quitting. Delivering tailored educational materials by text message or mail may increase interaction with information about menthol cigarettes and smoking cessation resources compared to those who do not receive the educational messaging.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
PRIMARY OBJECTIVES:
I. Assess participant interaction with an educational message about menthol cigarettes by tracking visits to the Quitline website.
II. Assess participant interaction with the educational message delivered by text message with a direct link to information about menthol cigarettes by tracking visits to the Quitline Web site.
III. Assess participant interaction with the educational message delivery by mail with a direct link to information about menthol cigarettes by tracking visits to the Quitline Web.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP I: Participants receive an educational flyer by mail along with the standard Quitline materials on study. Participants receive access to a website and quick response (QR) code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website.
GROUP II: Participants receive standard Quitline materials in the mail on study.
GROUP III: Participants receive an educational message by text along with the standard Quitline materials by mail on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
New York
-
Buffalo, New York, Vereinigte Staaten, 14263
- Roswell Park Cancer Institute
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Adults aged 18 years or older
- Residents of New York State
- English Speaking
- Willingness to receive and engage with mailed educational materials
- Participants with ability to receive text messaging access to smart device
Exclusion Criteria:
- Report currently smoking menthol cigarettes
- People who do not report currently smoking menthol cigarettes
- Individuals under 18 years of age
- Persons in correctional facilities
- Non-English speaking
- Participants who cannot receive text messaging or have access to smart device
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Cohort II (standard Quitline materials)
Participants receive standard Quitline materials in the mail on study. |
Receive standard Quitline materials
Andere Namen:
|
|
Experimental: Group I (educational material by mail)
Participants receive an educational flyer by mail along with the standard Quitline materials on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website. |
Receive standard Quitline materials
Andere Namen:
Receive an educational flyer by mail
Andere Namen:
Receive access to a website Receive access to a QR code
Andere Namen:
|
|
Experimental: Group III (educational messaging by text)
Participants receive an educational message by text along with the standard Quitline materials by mail on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website. |
Receive standard Quitline materials
Andere Namen:
Receive access to a website Receive access to a QR code
Andere Namen:
Receive an educational message by text
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Engagement with quick response (QR) code scans
Zeitfenster: Up to 12 months
|
QR code will be scanned will be tracked through unique uniform resource locator assigned. Each scan will be documented, allowing for the counting of interactions (Poisson) directly affiliated with the materials distributed. Also, binary (yes/no) (Did the participant interact at least once). Will be analyzed using chi-square tests or Fisher's exact tests. Bonferroni's correction will be used to adjust for three pairwise comparisons (alpha=0.05/3). |
Up to 12 months
|
|
Website Utilization
Zeitfenster: Up to 12 months
|
total number of visits, unique visitors, |
Up to 12 months
|
|
Interactions with online resources
Zeitfenster: Up to 12 months
|
Interactions with online resources will include the number of clicks on website, and time spent on various pages. Will be analyzed using chi-square tests or Fisher's exact tests. Bonferroni's correction will be used to adjust for three pairwise comparisons (alpha=0.05/3). |
Up to 12 months
|
|
Website utilization
Zeitfenster: Up to 12 months
|
Duration of sessions |
Up to 12 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of website interactions from the mailed flyer
Zeitfenster: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Number of QR code interactions from the mailed flyer
Zeitfenster: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Number of website interactions from the text message
Zeitfenster: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Number of QR code interactions from the text message
Zeitfenster: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Duration spent on the cessation website
Zeitfenster: Up to 12 months
|
Will assess depth of engagement. |
Up to 12 months
|
|
Number of pages or resources accessed on the website
Zeitfenster: Up to 12 months
|
Will evaluate participant utilization of the content. |
Up to 12 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Sarah Pearson-Collins, Roswell Park Cancer Institute
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
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
Zusätzliche relevante MeSH-Bedingungen
- Untersuchungstechniken
- Gesundheitsdienste
- Belegschaft und Dienstleistungen für Gesundheitseinrichtungen
- Kindergesundheitsdienste
- Community Health Services
- Präventive Gesundheitsdienste
- Sozioökonomische Faktoren
- Bevölkerungseigenschaften
- Herstellte Materialien
- Technologie, Industrie und Landwirtschaft
- Methoden
- Frühintervention, Bildung
- Bildungsstatus
- Rauchergeräte
Andere Studien-ID-Nummern
- I-4464925
- NCI-2025-03221 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
- I-4464925 (Andere Kennung: Roswell Park Cancer Institute)
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
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .