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

M.D. Anderson Cancer Center

Status: Completed

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

Treatments: Behavioral: Smoking Prevention Usual Care; Behavioral: Counseling Intervention

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00310115

P30CA016672 (U.S. NIH Grant/Contract)

R01CA089350 (U.S. NIH Grant/Contract)

BS01-178

CDR0000466327 (Registry Identifier)

MDA-BS01-178 (Other Identifier)

NCI-2010-01136 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 469 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 University of Texas MD Anderson Cancer Center (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

Trial design

469 participants in 3 patient groups

Smoking Prevention Usual Care

Description:

Arm I (usual care): Self-help materials and brief relapse prevention advice based on Treating Tobacco Use and Dependence Clinical Practice Guideline.

Treatment:

Behavioral: Smoking Prevention Usual Care

MRP

Description:

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.

Treatment:

Behavioral: Counseling Intervention

Behavioral: Counseling Intervention

Behavioral: Smoking Prevention Usual Care

Enhanced MRP +

Description:

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.

Treatment:

Behavioral: Counseling Intervention

Behavioral: Counseling Intervention

Behavioral: Smoking Prevention Usual Care