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

Lung Cancer Clinical Trial

Official title:

Smoking Relapse Prevention Among Postpartum Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310115
• Other study ID #: BS01-178
• Secondary ID: R01CA089350P30CA
• Status: Completed
• Phase: N/A
• First received: March 29, 2006
• Last updated: September 21, 2016
• Start date: April 2002
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 469
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Renal Cell
• Cervical Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Kidney Cancer
• Kidney Neoplasms
• Leukemia
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Lung Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms
• Tobacco Use Disorder
• Urinary Bladder Neoplasms
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Cigarettes Smoked Daily	Cigarettes smoked per day at 26 weeks following study treatment	26 weeks following study treatment	No

External Links

•   University of Texas MD Anderson Cancer Center Official Website