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Sponsors and Collaborators: |
Massachusetts General Hospital National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00664261 |
RATIONALE: The Clinical Effort Against Secondhand Smoke (CEASE) program may be more effective than standard care in increasing the number of parents who stop smoking.
PURPOSE: This randomized clinical trial is studying how well the CEASE program works compared with standard care in helping parents stop smoking.
Condition | Intervention |
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Health Status Unknown |
Procedure: counseling Procedure: educational intervention Procedure: laboratory biomarker analysis Procedure: questionnaire administration Procedure: smoking cessation intervention Procedure: study of high risk factors Procedure: survey administration |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control |
Official Title: | Addressing Parental Smoking by Changing Pediatric Office Systems |
Estimated Enrollment: | 3000 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Participants are stratified according to practice. Participants are randomized to 1 of 2 intervention arms.
The CEASE intervention also incorporates telephone counseling after the pediatric healthcare visit to ensure that parents receive professional, ongoing smoking-cessation counseling. Parental smokers undergo follow-up telephone surveys at 1 week, 3 months, and 12 months for evaluation of content of tobacco control delivered during the visit; use of messaging materials, medications, and telephone counseling sessions; current smoking status; and rules about smoking in the home and car. If the parent has had a 7-day quit at the 12-month follow-up, the parent is also asked to provide a saliva sample for cotinine analysis to confirm nonsmoking status.
In both arms, participating practitioners and key office staff complete Implementation Process Surveys at baseline and at 6 weeks and 6 months.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Parents or guardians meeting the following criteria:
Must have a child who is seen by a pediatrician in a participating practice
Pediatric practice meeting the following criteria:
Located in a geographically distinct location to minimize contamination effects of the intervention
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 |
Study Chair: | Jonathan Winickoff, MD, MPH | Massachusetts General Hospital |
Study ID Numbers: | CDR0000584270, MGH-200P002323 |
Study First Received: | April 19, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00664261 |
Health Authority: | Unspecified |
health status unknown |
Smoking |