Clinical trial NCT05123118: Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding
Official title: Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Cigarette
Breastfeeding
Keywords: Pregnancy
Postpartum
Smoking abstinence
Breastfeeding intention
Breastfeeding duration
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-11-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Smoking Abstinence
timeFrame: 6 months postpartum
measure: Number of Participants With Reported Intent to Breastfeed
timeFrame: 35 weeks of pregnancy (the end of pregnancy)
measure: Number of Participants Reporting to Breastfeed
timeFrame: 6 months postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Xiaozhong Wen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: