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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Smoking Relapse Prevention Among Postpartum Women

Conditions
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Kidney Cancer, Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: Smoking Prevention Usual Care
* Behavioral: Counseling Intervention
* Behavioral: Counseling Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Smoking Prevention Usual Care<br>Arm I (usual care): Self-help materials and brief relapse prevention advice based on Treating Tobacco Use and Dependence Clinical Practice Guideline. | Behavioral: Smoking Prevention Usual Care<br>* Usual care of self-help materials and advice for staying cigarette free<br>|
| MRP<br>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. | Behavioral: Smoking Prevention Usual Care<br>* Usual care of self-help materials and advice for staying cigarette free<br>Behavioral: Counseling Intervention<br>* 6 x 30 minute counseling sessions over the telephone<br>|
| Enhanced MRP +<br>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. | Behavioral: Smoking Prevention Usual Care<br>* Usual care of self-help materials and advice for staying cigarette free<br>Behavioral: Counseling Intervention<br>* 6 x 30 minute counseling sessions over the telephone<br>Behavioral: Counseling Intervention<br>* 2 in-person counseling sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Smoking Abstinence | Smoking abstinence as measured by the Society for Research on Nicotine and Tobacco Smoking Status Measure at 26 weeks following study treatment | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cigarettes Smoked Daily | Cigarettes smoked per day at 26 weeks following study treatment | 26 weeks following study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer, small cell lung cancer, bladder cancer, cervical cancer, esophageal cancer, gastric cancer, renal cell carcinoma, adult primary liver cancer, pancreatic cancer, hypopharyngeal cancer, lip and oral cavity cancer, laryngeal cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, adult acute myeloid leukemia, tobacco use disorder