Path2Quit Tobacco Intervention For African Americans
27. marts 2019 opdateret af: Case Comprehensive Cancer Center
Development and Pilot Evaluation of the Path2Quit Tobacco Intervention Targeting African Americans
The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program.
The study includes completing surveys and receiving text messages to help participants become tobacco free.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES Specific Aim 1: Translate a culturally specific video-based tobacco use intervention into a scalable mobile health (mhealth) format.
Specific Aim 2: Conduct a pilot study of the video-text intervention.
Study Design:
2-arm semi-pragmatic randomized design among current tobacco users
Cuyahoga Metropolitan Housing Authority residents will be randomly assigned to receive (1) the newly translated Path2Quit or (2) SmokeFreeText (NCI's publicly available, standard text messaging program) combined with brief behavioral counseling session plus 2 weeks of nicotine replacement therapy (NRT). Primary outcomes will include intervention evaluations (content and format), acceptability, coping strategies, engagement, and NRT adherence. Secondary variables will include 24-hour quit attempts and biochemically verified tobacco use abstinence at the 1-month follow-up. Exploratory mediational analyses will examine the roles of urban hassles, acculturation, neighborhood environment, ethnic discrimination, and psychological distress in intervention effects.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
119
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Case Western Reserve University, Case Comprehensive Cancer Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Self-identify as African American
- Either smoke at least 1 cigarettes/day or have a carbon monoxide (CO) reading of at least 4 ppm
- Consistent with SmokefreeTXT, be willing to set a quit date within the next 14 days.
- Recruited from Cleveland metropolitan housing authority or who report low income based on federal guidelines
Exclusion Criteria:
- Does not meet all of the above inclusion criteria
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Path2Quit
Culturally specific text message intervention
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Path2Quit will deliver 20-60 second video clips by multimedia messaging service.
The message library will include 75-170 messages.
Written text messages will be limited to brief phrases to indicate the topic of the video.
Messages will be pushed to participants in the morning, in the afternoon, and 2 hours before the reported usual bedtime.
The cultural adaptations will be infused throughout the video segments.
Topics include deep structure: race and smoking in general, African American smoking statistics; norms for smoking; concerns about nicotine replacement/medication; family/collectivism; unique stressors; racism/discrimination, depression; co-morbid addiction; neighborhood/environmental influences; menthol cigarettes; race-specific weight issues and concerns; and working as a community against the tobacco industry.
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Aktiv komparator: SmokeFreeText
The National Cancer Institute's publicly available, standard text messaging program for tobacco cessation
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SmokefreeTXT is a 6-8 week fully automated text-based cessation intervention.
The program is free to U.S. subscribers who have a mobile phone, and is available on smokefree.gov
or by texting "QUIT" to short code 47848.
Participants are encouraged to set a quit date within the next 14 days, followed by count-down messages leading to the quit date.
Starting on the quit date, participants receive 6 weeks of intervention text messages, and assessment questions (mood, cravings, smoking status).
The message library contains 166 messages and 41 behavior change techniques,40 which are delivered at the greatest frequency during the first 2 weeks and taper over time.
When in need of assistance, participants can text one of 3 keywords (MOOD, CRAVE, or SLIP) to receive a relevant message from the system.
Participants can opt-out by texting STOP at any time.
With informed consent, we will be able to access the SmokefreeTXT data for these participants.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of participants who abstain from smoking
Tidsramme: At 1-month follow-up
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Abstinence will be coded as a binary variable.
Analysis will be conducted with an intent to treat approach
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At 1-month follow-up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of missed nicotine replacement therapy doses
Tidsramme: Up to 1-month follow-up
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Measure of NRT adherence.
Number of missed doses will be recorded for each participant
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Up to 1-month follow-up
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24-Hour quit attempts
Tidsramme: At 1-month follow-up
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Number of times a participant quits smoking for at least 24 hours
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At 1-month follow-up
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Changes in carbon monoxide breath levels from baseline to followup
Tidsramme: At 1-month follow-up
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Breath carbon monoxide tests will biochemically confirm self-reported cessation
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At 1-month follow-up
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Changes in Contemplation ladder score
Tidsramme: From baseline to up to 1-month follow-up
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self-reported score 0-10 where a higher score indicates more readiness to quit
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From baseline to up to 1-month follow-up
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Average score of Intervention Evaluation (IRQ)
Tidsramme: At 1-month follow-up
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The IRQ is a 22 item scale scored 0-7 (total score 0-154) where higher scores indicate more satisfaction
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At 1-month follow-up
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Average score of smoking urges
Tidsramme: Up to 1-month follow-up
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This brief, 10 item scale is scores 1-7 (total score 10-70) with higher scores indicating greater agreement
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Up to 1-month follow-up
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Average scores of Urban hassles
Tidsramme: Changes from baseline to 1 month follow-up
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This is a 63 item scale scored 0-5 (total score 0-315) where higher scores indicate more severe hassle
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Changes from baseline to 1 month follow-up
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Average Neighborhood Environment scale score
Tidsramme: At Baseline
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The neighborhood environment scale is an 18 item True or False scale
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At Baseline
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Average General Ethnic Discrimination Scale Score
Tidsramme: At baseline
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This is a measure of ethnic discrimination.
These 16 items are scored 1-6 (total score 16-96) with higher scores indicating greater levels of ethnic discrimination
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At baseline
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Average psychological distress score using the the perceived stress scale
Tidsramme: At baseline
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A ten item scale with each item scored 0-4 (total score 0-40) where higher scores indicate more stress.
Positive items are scored in reverse.
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At baseline
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Average depression score using Center for Epidemiological Studies Depression (CES-D) Scale
Tidsramme: At baseline
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A twenty item scale ranging from 0-60 with each item scored 0-3.
Higher scores indicate more depression
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At baseline
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Average Beliefs and Attitudes Survey Score
Tidsramme: At baseline
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This is a 24 item scale (total range 24-168) with each item scored 1-7.
Higher scores indicate greater levels of agreement
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At baseline
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Average Ethnic Identity Score
Tidsramme: At baseline
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This is based on the Multigroup Ethnic Identity Measure scale.
These five items are scored 1-4 for a total score of 5-20.
Higher scores indicate stronger ethnic identity
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At baseline
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Average Culturally Specific Interventions Expectancy Questionnaire
Tidsramme: At baseline
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The Culturally Specific Interventions Expectancy Questionnaire is a 2 item scale with each item ranging 1-5 (total score 2-10) where higher scores indicate greater agreement.
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At baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Monica Webb Hooper, PhD, Case Comprehensive Cancer Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2018
Primær færdiggørelse (Faktiske)
20. august 2018
Studieafslutning (Faktiske)
20. august 2018
Datoer for studieregistrering
Først indsendt
30. april 2018
Først indsendt, der opfyldte QC-kriterier
11. maj 2018
Først opslået (Faktiske)
14. maj 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. marts 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. marts 2019
Sidst verificeret
1. marts 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- CASE1Y18
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Path2Quit
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Case Comprehensive Cancer CenterAfsluttetOphør med tobaksbrugForenede Stater
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Case Comprehensive Cancer CenterAfsluttetRygestopForenede Stater