We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00310115
First Posted: April 3, 2006
Last Update Posted: September 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  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 Cervical Cancer Esophageal Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Leukemia Liver Cancer Lung Cancer Pancreatic Cancer Tobacco Use Disorder Behavioral: Smoking Prevention Usual Care Behavioral: Counseling Intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Smoking Relapse Prevention Among Postpartum Women

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients with Smoking Abstinence [ Time Frame: 26 weeks ]
    Smoking abstinence as measured by the Society for Research on Nicotine and Tobacco Smoking Status Measure at 26 weeks following study treatment


Secondary Outcome Measures:
  • Number of Cigarettes Smoked Daily [ Time Frame: 26 weeks following study treatment ]
    Cigarettes smoked per day at 26 weeks following study treatment


Enrollment: 469
Study Start Date: April 2002
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Smoking Prevention Usual Care
Arm I (usual care): Self-help materials and brief relapse prevention advice based on Treating Tobacco Use and Dependence Clinical Practice Guideline.
Behavioral: Smoking Prevention Usual Care
Usual care of self-help materials and advice for staying cigarette free
MRP
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.
Behavioral: Smoking Prevention Usual Care
Usual care of self-help materials and advice for staying cigarette free
Behavioral: Counseling Intervention
6 x 30 minute counseling sessions over the telephone
Enhanced MRP +
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.
Behavioral: Smoking Prevention Usual Care
Usual care of self-help materials and advice for staying cigarette free
Behavioral: Counseling Intervention
6 x 30 minute counseling sessions over the telephone
Behavioral: Counseling Intervention
2 in-person counseling sessions

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women, 18 years of age or older, who quit smoking while pregnant.
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310115


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: David Wetter, PhD, BS, BA M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00310115     History of Changes
Other Study ID Numbers: BS01-178
R01CA089350 ( U.S. NIH Grant/Contract )
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-BS01-178 ( Other Identifier: UT MD Anderson Cancer Center )
CDR0000466327 ( Registry Identifier: NCI PDQ )
NCI-2010-01136 ( Registry Identifier: NCI CTRP )
First Submitted: March 29, 2006
First Posted: April 3, 2006
Last Update Posted: September 23, 2016
Last Verified: September 2016

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Lung Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Head and Neck Neoplasms
Uterine Cervical Neoplasms
Urinary Bladder Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Tobacco Use Disorder
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases