Smoking Relapse Prevention Among Postpartum Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 469
- Locations
- 1
- Primary Endpoint
- Number of Patients with Smoking Abstinence
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •high-risk pregnancy or known negative birth outcome
Outcomes
Primary Outcomes
Number of Patients with Smoking Abstinence
Time Frame: 26 weeks
Smoking abstinence as measured by the Society for Research on Nicotine and Tobacco Smoking Status Measure at 26 weeks following study treatment
Secondary Outcomes
- Number of Cigarettes Smoked Daily(26 weeks following study treatment)