|Grant Number:||5R01CA075455-05 Interpret this number|
|Primary Investigator:||Greene, Paul|
|Organization:||University Of Alabama At Birmingham|
|Project Title:||Smoking Cessation to Reduce Cervical Cancer Risk|
DESCRIPTION: Cervical cancer is a major source of morbidity and mortality among women, with a particularly high burden evidenced among women in Alabama. Although HPV has been identified as the major causative agent for cervical cancer, most women with HPV do not develop cervical neoplasia, suggesting that progression to cervical cancer may be influenced by other factors. Smoking has consistently been associated with increased risk for cervical cancer, even among women already at elevated risk due to cervical dysplasia and HPV infection. Further, available data suggest that smoking cessation may decrease cervical cancer risk. These data justify a prospective, controlled study, examining the efficacy of smoking cessation in halting the progression of cervical dysplasia. The proposed 5-year clinical trial will evaluate the effect of a theory-based smoking cessation intervention on progression from low-grade squamous intraepithelial lesions (LSIL) to high-grade squamous intraepithelial lesions (HSIL) in female smokers with HPV. The plan is to recruit 220 current smokers ((10 cigarettes/day) with oncogenic HPV from the University of Alabama at Birmingham Colposcopy Clinic and randomly assign them to one of two treatment conditions: 1)usual care (UC); or 2) smoking cessation intervention (SCI). Patients in both groups will receive standard conservative management for LSIL, biannual pap smears and more aggressive treatment, as needed. Additionally, patients in the SCI group will also participate in an intensive smoking cessation intervention which will include: 1) cognitive-behavioral strategies to facilitate changes in smoking behavior; 2) short-term nicotine replacement therapy to minimize discomfort associated with nicotine withdrawal; and 3) a motivational intervention to promote the optimal use of cognitive-behavioral strategies and nicotine replacement therapy. The primary outcome will be rate of biopsy-confirmed progression to HSIL over 18-month follow-up. The investigators also propose to collect self-report and biochemical measures of smoking status and dysplasia progression. Finally, perceptions about cancer risk and cancer control practices will be assessed to examine relationships with smoking cessation program participation and changes in smoking.