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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Smoking, Cigarette, Breastfeeding

Intervention / Treatment
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* Behavioral: Integrated intervention of smoking cessation and breastfeeding
* Behavioral: Attention placebo control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 18 years or older At ≤28 weeks of pregnancy Daily smoking cigarettes and/or cigars in the past 7 days Be able to read, listen, and talk in English 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The 40 eligible participants will be randomized into either the intervention (N=20) or control group (N=20). A sequence of random numbers in blocks of 2 will be used to ensure equal numbers of participants for each group over time.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated intervention<br>Integrated intervention of smoking cessation and breastfeeding | Behavioral: Integrated intervention of smoking cessation and breastfeeding<br>* The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives.<br>|
| Active Comparator: Attention placebo control group<br>Instructions on general pregnancy and infant care | Behavioral: Attention placebo control<br>* Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking abstinence | 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).60,61 The self-reported smoking abstinence will be biochemically confirmed by urine cotinine tests (<50 ng/mL). | 6 months postpartum | 
| Breastfeeding intention | During pregnancy, participants will report breastfeeding intention using questionnaires modified from the Infant Feeding Practices Study II. | 35 weeks of pregnancy (the end of pregnancy) | 
| Breastfeeding status | During postpartum, mothers will report breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 6 months postpartum. | 6 months postpartum | 
| Breastfeeding frequency | During postpartum, mothers will report breastfeeding frequency (times per day) every month until 6 months postpartum. | 6 months postpartum | 
| Breastfeeding duration | During postpartum, mothers will update breastfeeding duration (weeks) every month until 6 months postpartum. | 6 months postpartum | 
| Formula duration | During postpartum, mothers will update formula duration (weeks) every month until 6 months postpartum. | 6 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Postpartum, Smoking abstinence, Breastfeeding intention, Breastfeeding duration