- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
New York
-
Buffalo, New York, Forente stater, 14263
- Roswell Park Cancer Institute
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Cohort II (standard Quitline materials)
Participants receive standard Quitline materials in the mail on study. |
Receive standard Quitline materials
Andre navn:
|
|
Eksperimentell: 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
Andre navn:
Receive an educational flyer by mail
Andre navn:
Receive access to a website Receive access to a QR code
Andre navn:
|
|
Eksperimentell: 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
Andre navn:
Receive access to a website Receive access to a QR code
Andre navn:
Receive an educational message by text
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Engagement with quick response (QR) code scans
Tidsramme: 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
Tidsramme: Up to 12 months
|
total number of visits, unique visitors, |
Up to 12 months
|
|
Interactions with online resources
Tidsramme: 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
Tidsramme: Up to 12 months
|
Duration of sessions |
Up to 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of website interactions from the mailed flyer
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Duration spent on the cessation website
Tidsramme: Up to 12 months
|
Will assess depth of engagement. |
Up to 12 months
|
|
Number of pages or resources accessed on the website
Tidsramme: Up to 12 months
|
Will evaluate participant utilization of the content. |
Up to 12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Sarah Pearson-Collins, Roswell Park Cancer Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Undersøkelsesteknikker
- Helsetjenester
- Helsetjenester arbeidsstyrke og tjenester
- Barnehelsetjenester
- Community Health Services
- Forebyggende helsetjenester
- Sosioøkonomiske faktorer
- Befolkningskarakteristikker
- Produsert materiale
- Teknologi, industri og landbruk
- Metoder
- Tidlig intervensjon, pedagogisk
- Utdanningsstatus
- Røykeenheter
Andre studie-ID-numre
- I-4464925
- NCI-2025-03221 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- I-4464925 (Annen identifikator: Roswell Park Cancer Institute)
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