Flexiquit+: Web Program to Promote Smoking Cessation in Sexual and Gender Minority Young Adult Smokers (EQQUAL)
2. oktober 2020 oppdatert av: Fred Hutchinson Cancer Center
A Scalable E-Health Smoking Cessation Intervention for Sexual and Gender Minority Young Adults
This phase I trial studies how well Flexiquit+ helps young adult smokers who identify as a sexual and/or gender minority to quit or cut down on smoking.
Flexiquit+ is an avatar-led, web-based intervention that can help smokers quit or cut back on how much they smoke cigarettes and/or vape, reducing their chances of developing tobacco-related health conditions.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
OUTLINE:
Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.
Participants are followed up with at 2 months.
Studietype
Intervensjonell
Registrering (Faktiske)
25
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Washington
-
Seattle, Washington, Forente stater, 98109
- Fred Hutch/University of Washington Cancer Consortium
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 30 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Participants must self-identify as a sexual and/or gender minority (i.e., a sexual orientation other than straight and/or gender that doesn't match sex assigned at birth)
- Participants must currently reside in the United States and anticipate remaining in the United States for the duration of the study (2 months)
- Participants must self-report smoking at least 1 cigarette per day in the 30 days prior to screening
- Participants must self-report having at least weekly internet access for the next two months
- Participants must self-report being willing and able to stream video online for this study
- Participants must self-report current use of a personal email account
- Participants must self-report current use of text messaging
- Participants must self-report that they are interested in participating in the study for themselves (versus [vs] someone else)
- Participants must self-report that they are not currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program
- Participants must self-report that they have not participated in one of our prior smoking cessation studies, including the user-centered research conducted in the development of Flexiquit+
- Participants must self-report that they are comfortable reading, writing, and speaking English
- Participants must self-report that they understand and agree to the conditions of compensation
- Participants must self-report that they are not currently incarcerated in a prison
- Participants must be willing to use the Flexiquit+ program, complete the study assessments, and sign an online consent form
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Prevention (Flexiquit+, text message, handout)
Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes.
Participants will also receive text messages providing motivational messages and review information discussed in the program.
At the end of the intervention, participants will receive an email with all of the session handouts.
|
Hjelpestudier
Andre navn:
Hjelpestudier
Hjelpestudier
Motta tekstmeldinger
Andre navn:
Use the Flexiquit+ program
Receive handouts via email
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment utilization
Tidsramme: Enrollment up to 2 months
|
Will be determined by the server-recorded number of logins and the number of sessions completed.
Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction.
Tables with N (%) or mean (standard deviation) by treatment arm will be provided.
|
Enrollment up to 2 months
|
|
Treatment satisfaction: survey
Tidsramme: Enrollment up to 2 months
|
Will be determined using 12 items on the 2-month outcome survey.
Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction.
Categorical ratings for treatment satisfaction questions will be dichotomized as "somewhat", "mostly", or "very" useful versus (vs.) lower ratings.
Tables with N (%) or mean (standard deviation) by treatment arm will be provided.
|
Enrollment up to 2 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Smoking cessation rate
Tidsramme: At 2 months post-enrollment
|
Will be assessed using the self-reported 7-day point prevalence abstinence at 2-month follow-up survey, biochemically confirmed with saliva cotinine.
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At 2 months post-enrollment
|
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Change in motivation to quit smoking
Tidsramme: From baseline to 2-month follow-up
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Will be assessed using the Contemplation Ladder.
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From baseline to 2-month follow-up
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Jaimee Heffner, Fred Hutch/University of Washington Cancer Consortium
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. mai 2020
Primær fullføring (Faktiske)
1. september 2020
Studiet fullført (Faktiske)
1. september 2020
Datoer for studieregistrering
Først innsendt
9. desember 2019
Først innsendt som oppfylte QC-kriteriene
10. desember 2019
Først lagt ut (Faktiske)
11. desember 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. oktober 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. oktober 2020
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RG1004771
- P30CA015704 (U.S. NIH-stipend/kontrakt)
- 10396 (Annen identifikator: Fred Hutch/University of Washington Cancer Consortium)
- NCI-2019-08031 (Registeridentifikator: NCI / CTRP)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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