Smoking Relapse Prevention Among Postpartum Women
18 Years
N/A
Female
Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder
Trial Information
Smoking Relapse Prevention Among Postpartum Women
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Number of Patients with Smoking Abstinence
Outcome Description:
Smoking abstinence as measured by the Society for Research on Nicotine and Tobacco Smoking Status Measure at 26 weeks following study treatment
Outcome Time Frame:
26 weeks
Safety Issue:
No
Principal Investigator
David Wetter, PhD, BS, BA
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
BS01-178
NCT ID:
NCT00310115
Start Date:
July 2005
Completion Date:
November 2015
Related Keywords:
- Bladder Cancer
- Cervical Cancer
- Esophageal Cancer
- Gastric Cancer
- Head and Neck Cancer
- Kidney Cancer
- Leukemia
- Liver Cancer
- Lung Cancer
- Pancreatic Cancer
- Tobacco Use Disorder
- 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
- Urinary Bladder Neoplasms
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Uterine Cervical Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Head and Neck Neoplasms
- Leukemia
- Liver Neoplasms
- Lung Neoplasms
- Stomach Neoplasms
- Pancreatic Neoplasms
- Smoking
- Tobacco Use Disorder
Name | Location |
|---|---|
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
