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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA089350 | U.S. NIH Grant/Contract | View source | |
| P30CA016672 | U.S. NIH Grant/Contract | View source | |
| MDA-BS01-178 | Other Identifier | UT MD Anderson Cancer Center | |
| CDR0000466327 | Registry Identifier | NCI PDQ | |
| NCI-2010-01136 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: This is a randomized study. Participants are randomized to 1 of 3 intervention arms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking Prevention Usual Care | Behavioral | Usual care of self-help materials and advice for staying cigarette free |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cigarettes Smoked Daily | Cigarettes smoked per day at 26 weeks following study treatment | 26 weeks following study treatment |
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Inclusion Criteria:
Exclusion Criteria:
1) high-risk pregnancy or known negative birth outcome
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Women, 18 years of age or older, who quit smoking while pregnant.
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| Name | Affiliation | Role |
|---|---|---|
| David Wetter, PhD, BS, BA | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Official Website | View source |
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| Counseling Intervention | Behavioral | 6 x 30 minute counseling sessions over the telephone |
|
| Counseling Intervention | Behavioral | 2 in-person counseling sessions |
|
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D007680 | Kidney Neoplasms |
| D007938 | Leukemia |
| D008113 | Liver Neoplasms |
| D008175 | Lung Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D014029 | Tobacco Use Disorder |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D002292 | Carcinoma, Renal Cell |
| D006528 | Carcinoma, Hepatocellular |
| D007012 | Hypopharyngeal Neoplasms |
| D009062 | Mouth Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007674 | Kidney Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008107 | Liver Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009059 | Mouth Diseases |
| D007818 | Laryngeal Diseases |
| D009302 | Nasopharyngeal Diseases |
| D007951 | Leukemia, Myeloid |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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