Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Motivational Counseling in Preventing Smoking Relapse After Pregnancy in Pregnant Women Who Quit Smoking During Pregnancy
This study has been completed.
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00310115
  Purpose

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.


Condition Intervention
Bladder Cancer
Cancer-Related Problem/Condition
Cervical Cancer
Esophageal Cancer
Gastric Cancer
Head and Neck Cancer
Kidney Cancer
Leukemia
Liver Cancer
Lung Cancer
Pancreatic Cancer
Procedure: counseling
Procedure: smoking cessation intervention

Genetics Home Reference related topics: bladder cancer
MedlinePlus related topics: Bladder Cancer Cancer Esophageal Cancer Esophagus Disorders Head and Neck Cancer Kidney Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Liver Cancer Lung Cancer Pancreatic Cancer Smoking Stomach Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized
Official Title: Smoking Relapse Prevention Among Postpartum Women

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Smoking abstinence as measured by the Society for Research on Nicotine and Tobacco Smoking Status Measure at 26 weeks following study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cigarettes per day at 26 weeks following study treatment [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: July 2005
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Former smoker

    • Smoked an average of > 1 cigarette per day during the year prior to the current pregnancy
    • Quit smoking during pregnancy
  • Gestational age < 33 weeks
  • Able to attend an in-person visit between 30-33 weeks of gestational age
  • No high-risk pregnancy
  • No known negative birth outcome

PATIENT CHARACTERISTICS:

  • Able to speak, read, and write English
  • Functioning home or cell phone

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310115

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Investigator: Shanna L. Barnett, Dr PH M.D. Anderson Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000466327, MDA-BS01-178
Study First Received: March 29, 2006
Last Updated: December 3, 2008
ClinicalTrials.gov Identifier: NCT00310115  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Liver Diseases
Pancreatic Neoplasms
Urogenital Neoplasms
Urologic Neoplasms
Dental Caries
Smoking
Lung Neoplasms
Oral cancer
Laryngeal carcinoma
Acute myeloid leukemia, adult
Kidney Diseases
Endocrine Gland Neoplasms
Non-small cell lung cancer
Digestive System Neoplasms
Tobacco Use Disorder
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Acute myelogenous leukemia
Endocrine System Diseases
Stomach cancer
Renal cancer
Leukemia, Myeloid
Lip and oral cavity cancer
Carcinoma
Carcinoma, Small Cell
Lung Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Esophageal Diseases

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009