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Spots Global Cancer Trial Database for Motivational Counseling in Preventing Smoking Relapse After Pregnancy in Pregnant Women Who Quit Smoking During Pregnancy

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Trial Identification

Brief Title: Motivational Counseling in Preventing Smoking Relapse After Pregnancy in Pregnant Women Who Quit Smoking During Pregnancy

Official Title: Smoking Relapse Prevention Among Postpartum Women

Study ID: NCT00310115

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Contact Details

Name: David Wetter, PhD, BS, BA

Affiliation: M.D. Anderson Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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