- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00310115
Motivational Counseling in Preventing Smoking Relapse After Pregnancy in Pregnant Women Who Quit Smoking During Pregnancy
Smoking Relapse Prevention Among Postpartum Women
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030-4009
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age 18 or older
- former smoker who quit during pregnancy as assessed via self-report
- smoked an average of greater than or equal to 1 cigarette per day during the year prior to the current pregnancy
- 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
- can speak, read and write in English.
- must have a functioning home or personal cell phone
Exclusion Criteria:
1) high-risk pregnancy or known negative birth outcome
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
Usual care of self-help materials and advice for staying cigarette free
6 x 30 minute counseling sessions over the telephone
2 in-person counseling sessions
|
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.
|
Usual care of self-help materials and advice for staying cigarette free
6 x 30 minute counseling sessions over the telephone
2 in-person counseling sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Cigarettes Smoked Daily
Time Frame: 26 weeks following study treatment
|
Cigarettes smoked per day at 26 weeks following study treatment
|
26 weeks following study treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Wetter, PhD, BS, BA, M.D. Anderson Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- non-small cell lung cancer
- esophageal cancer
- bladder cancer
- gastric cancer
- pancreatic cancer
- renal cell carcinoma
- small cell lung cancer
- cervical cancer
- oropharyngeal cancer
- laryngeal cancer
- hypopharyngeal cancer
- adult primary liver cancer
- lip and oral cavity cancer
- nasopharyngeal cancer
- paranasal sinus and nasal cavity cancer
- adult acute myeloid leukemia
- tobacco use disorder
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Digestive System Diseases
- Substance-Related Disorders
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Liver Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Head and Neck Neoplasms
- Esophageal Diseases
- Pancreatic Diseases
- Uterine Cervical Neoplasms
- Stomach Neoplasms
- Lung Neoplasms
- Tobacco Use Disorder
- Urinary Bladder Neoplasms
- Pancreatic Neoplasms
- Liver Neoplasms
- Esophageal Neoplasms
Other Study ID Numbers
- BS01-178
- P30CA016672 (U.S. NIH Grant/Contract)
- R01CA089350 (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)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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