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

Official Title: “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.

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.

Intervention(s) in this Clinical Trial

• Behavioral: Smoking Prevention Usual Care
  • Usual care of self-help materials and advice for staying cigarette free
• Behavioral: Counseling Intervention
  • 6 x 30 minute counseling sessions over the telephone
• Behavioral: Counseling Intervention
  • 2 in-person counseling sessions

Arms, Groups and Cohorts in this Clinical Trial

• : 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.
• : 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.
• : 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.

Primary Measures

• Number of Patients with Smoking Abstinence
  • Time Frame: 26 weeks
    Safety Issue?: No

Secondary Measures

• Number of Cigarettes Smoked Daily
  • Time Frame: 26 weeks following study treatment
    Safety Issue?: No

Inclusion Criteria:

• 1. age 18 or older
• 2. former smoker who quit during pregnancy as assessed via self-report
• 3. smoked an average of greater than or equal to 1 cigarette per day during the year prior to the current pregnancy
• 4. gestational age < 33 weeks and ability to attend an in-person visit at UTMDACC between 30-33 weeks of gestational age
• 5. can speak, read and write in English.
• 6. must have a functioning home or personal cell phone

Exclusion Criteria:

• 1) high-risk pregnancy or known negative birth outcome

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: M.D. Anderson Cancer Center Other

Overall Clinical Trial Officials and Contacts

David Wetter, PhD, BS, BA Study Chair M.D. Anderson Cancer Center  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00310115

Study ID Number: BS01-178

ClinicalTrials.gov Identifier: NCT00310115

Health Authority: United States: Institutional Review Board

Clinical trial summary from the National Cancer Institute's PDQ® database

UT MD Anderson Cancer Center Website