Overview

This trial is active, not recruiting.

Conditions bladder cancer, cervical cancer, esophageal cancer, gastric cancer, head and neck cancer, kidney cancer, leukemia, liver cancer, lung cancer, pancreatic cancer, tobacco use disorder
Treatments smoking prevention usual care, counseling intervention
Sponsor M.D. Anderson Cancer Center
Collaborator National Cancer Institute (NCI)
Start date July 2005
End date November 2017
Trial size 650 participants
Trial identifier NCT00310115, BS01-178, CDR0000466327, MDA-BS01-178, NCI-2010-01136, P30CA016672, R01CA089350

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Arm I (usual care): Self-help materials and brief relapse prevention advice based on Treating Tobacco Use and Dependence Clinical Practice Guideline.
smoking prevention usual care
Usual care of self-help materials and advice for staying cigarette free
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.
smoking prevention usual care
Usual care of self-help materials and advice for staying cigarette free
counseling intervention
6 x 30 minute counseling sessions over the telephone
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.
smoking prevention usual care
Usual care of self-help materials and advice for staying cigarette free
counseling intervention
6 x 30 minute counseling sessions over the telephone
counseling intervention
2 in-person counseling sessions

Primary Outcomes

Measure
Number of Patients with Smoking Abstinence
time frame: 26 weeks

Secondary Outcomes

Measure
Number of Cigarettes Smoked Daily
time frame: 26 weeks following study treatment

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Smoking Relapse Prevention Among Postpartum Women
Principal investigator David Wetter, PhD, BS, BA
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.
Location data was received from the National Cancer Institute and was last updated in June 2016.