- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00310115
Motivational Counseling in Preventing Smoking Relapse After Pregnancy in Pregnant Women Who Quit Smoking During Pregnancy
Smoking Relapse Prevention Among Postpartum Women
RATIONALE: Motivational counseling may help prevent pregnant women from smoking again after pregnancy.
PURPOSE: This randomized clinical trial is studying three different types of counseling to see how well they work in preventing smoking relapse after pregnancy in pregnant women who quit smoking during pregnancy.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
OBJECTIVES:
- Develop and evaluate 2 "Motivational Relapse Prevention" (MRP) treatments of varying intensity for reducing postpartum smoking relapse among pregnant women who quit smoking during pregnancy.
- Assess MRP and Enhanced MRP (MRP+) effects on treatment mechanisms and the role of those mechanisms in mediating MRP and MRP+ effects on abstinence.
- Assess the cost-effectiveness of both the MRP and MRP+ treatments relative to each other and to usual care for reducing postpartum smoking relapse.
OUTLINE: This is a randomized study. Participants are randomized to 1 of 3 intervention arms.
- Arm I (usual care [UC]): Participants receive self-help materials and brief relapse prevention advice based on the Treating Tobacco Use and Dependence Clinical Practice Guideline.
- Arm II (motivational relapse prevention [MRP]): Participants receive the same intervention as in arm I. Participants also undergo telephone counseling over 30 minutes at 34 and 36 weeks gestation and then at 2, 4, 7, and 16 weeks postpartum.
- Arm III (enhanced MRP [MRP+]): Participants receive the same intervention as in arm I and telephone counseling as in arm II. Participants also undergo in-person counseling over 1 hour at 30-33 weeks gestation and then at 8 weeks postpartum.
Participants in all arms complete questionnaires at baseline, at 30-33 weeks gestation, and then at 8 and 26 weeks postpartum.
Participants are followed at 8 and 26 weeks postpartum.
PROJECTED ACCRUAL: A total of 450 participants will be accrued for this study.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Texas
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Houston, Texas, Forenede Stater, 77030-4009
- University of Texas MD Anderson Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- age 18 or older
- former smoker who quit during pregnancy as assessed via self-report
- smoked an average of greater than or equal to 1 cigarette per day during the year prior to the current pregnancy
- gestational age < 33 weeks and ability to attend an in-person visit at University of Texas MD Anderson Cancer Center (UTMDACC) between 30-33 weeks of gestational age
- can speak, read and write in English.
- must have a functioning home or personal cell phone
Exclusion Criteria:
1) high-risk pregnancy or known negative birth outcome
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Smoking Prevention Usual Care
Arm I (usual care): Self-help materials and brief relapse prevention advice based on Treating Tobacco Use and Dependence Clinical Practice Guideline.
|
Usual care of self-help materials and advice for staying cigarette free
|
MRP
Arm II (motivational relapse prevention [MRP]): Same intervention as usual care, plus 30 minutes telephone counseling at 34 & 36 weeks gestation then at 2, 4, 7, & 16 weeks postpartum.
|
Usual care of self-help materials and advice for staying cigarette free
6 x 30 minute counseling sessions over the telephone
2 in-person counseling sessions
|
Enhanced MRP +
Arm III (enhanced MRP [MRP+]): Same intervention as usual care and telephone counseling as MRP, plus 1 hour in-person counseling at 30-33 weeks gestation & 8 weeks postpartum.
|
Usual care of self-help materials and advice for staying cigarette free
6 x 30 minute counseling sessions over the telephone
2 in-person counseling sessions
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Patients with Smoking Abstinence
Tidsramme: 26 weeks
|
Smoking abstinence as measured by the Society for Research on Nicotine and Tobacco Smoking Status Measure at 26 weeks following study treatment
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26 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Cigarettes Smoked Daily
Tidsramme: 26 weeks following study treatment
|
Cigarettes smoked per day at 26 weeks following study treatment
|
26 weeks following study treatment
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: David Wetter, PhD, BS, BA, M.D. Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- ikke-småcellet lungekræft
- kræft i spiserøret
- blærekræft
- mavekræft
- kræft i bugspytkirtlen
- nyrecellekarcinom
- småcellet lungekræft
- livmoderhalskræft
- orofaryngeal cancer
- larynxkræft
- hypopharyngeal cancer
- primær leverkræft hos voksne
- læbe- og mundhulekræft
- nasopharyngeal cancer
- paranasal sinus og næsehulekræft
- akut myeloid leukæmi hos voksne
- forstyrrelse af tobaksbrug
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Kemisk inducerede lidelser
- Sygdomme i fordøjelsessystemet
- Stof-relaterede lidelser
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Urologiske sygdomme
- Urinblæresygdomme
- Uterine neoplasmer
- Genitale neoplasmer, kvindelige
- Livmoderhalssygdomme
- Livmodersygdomme
- Sygdomme i det endokrine system
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Mavesygdomme
- Neoplasmer i endokrine kirtler
- Leversygdomme
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Neoplasmer i hoved og hals
- Esophageale sygdomme
- Pancreassygdomme
- Uterine cervikale neoplasmer
- Neoplasmer i maven
- Lungeneoplasmer
- Tobaksbrugsforstyrrelse
- Urinblære neoplasmer
- Bugspytkirtel neoplasmer
- Neoplasmer i leveren
- Esophageale neoplasmer
Andre undersøgelses-id-numre
- BS01-178
- P30CA016672 (U.S. NIH-bevilling/kontrakt)
- R01CA089350 (U.S. NIH-bevilling/kontrakt)
- MDA-BS01-178 (Anden identifikator: UT MD Anderson Cancer Center)
- CDR0000466327 (Registry Identifier: NCI PDQ)
- NCI-2010-01136 (Registry Identifier: NCI CTRP)
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Kliniske forsøg med Smoking Prevention Usual Care
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