Path2Quit Tobacco Intervention For African Americans
27. März 2019 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
119
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44106
- Case Western Reserve University, Case Comprehensive Cancer Center
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Aktiver 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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Proportion of participants who abstain from smoking
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of missed nicotine replacement therapy doses
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Average scores of Urban hassles
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Monica Webb Hooper, PhD, Case Comprehensive Cancer Center
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. April 2018
Primärer Abschluss (Tatsächlich)
20. August 2018
Studienabschluss (Tatsächlich)
20. August 2018
Studienanmeldedaten
Zuerst eingereicht
30. April 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
11. Mai 2018
Zuerst gepostet (Tatsächlich)
14. Mai 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
28. März 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
27. März 2019
Zuletzt verifiziert
1. März 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- CASE1Y18
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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