Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding

Not Applicable

Completed

Interventions: Behavioral: Attention placebo control
Behavioral: Integrated intervention of smoking cessation and breastfeeding

Brief Summary: This pilot clinical trial aims to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their early pregnancy and randomize them into the integrated intervention or control group. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum.

Detailed Description: The investigators are proposing the first randomized controlled trial to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their 1st or 2nd trimester of pregnancy (≤28 weeks) from local obstetric clinics, communities, and social media. They will be randomized into either the intervention (N=20) or control group (N=20). The two groups will complete the same number of sessions (6 during pregnancy and 3 postpartum), but focus on different topics. Specifically, the control group will receive instructions on general pregnancy and infant care. The intervention group will receive instructions on general pregnancy and infant care, plus an integrated multicomponent intervention that promotes both smoking cessation and breastfeeding (i.e., education and counseling, monitoring and feedback, and contingent financial incentives). Two female Certified Lactation Counselors (interventionists) will be trained to run study sessions during home visits. Interventionists will provide additional support via phone and text messaging until 6 months postpartum. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum within the duration of this award.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Being diagnosed with cancer
Current heavy drinking (more than 2 drinks a day)
Current use of illicit substances
Medical conditions contraindicating breastfeeding such as HIV infection, active tuberculosis, and breast removal

Arm && Interventions

Group	Intervention	Description
Attention placebo control group	Attention placebo control	Instructions on general pregnancy and infant care
Integrated intervention	Integrated intervention of smoking cessation and breastfeeding	Integrated intervention of smoking cessation and breastfeeding

Primary Outcome Measures

Name	Time	Method
Number of Participants With Smoking Abstinence	6 months postpartum	Based on their recorded daily numbers of cigarettes and cigars smoked after enrollment, the investigators will classify smoking abstinence status in the past 7 days (7-day point-prevalence). The self-reported smoking abstinence will be biochemically confirmed by urine cotinine tests (\<50 ng/mL).
Number of Participants With Reported Intent to Breastfeed	35 weeks of pregnancy (the end of pregnancy)	During pregnancy, participants will report breastfeeding intention using questionnaires modified from the Infant Feeding Practices Study II. The question is, "What method do you plan to use to feed your new baby in the first few weeks?" with 4 response options: 1) breastfeeding only (baby will not be given formula), 2) formula feed only, 3) both breastfeed and formula feed, or 4) unsure. We create a binary variable to indicate breastfeeding intentions (option 1 or 3) or other feeding intentions (option 2 or 4).
Number of Participants Reporting to Breastfeed	6 months postpartum	During postpartum, mothers report their breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 6 months postpartum. Any breastfeeding is defined as exclusive breastfeeding or mixed-feeding breast milk and formula.

Secondary Outcome Measures

Name	Time	Method

Locations (1): Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo
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Buffalo, New York, United States