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

Xiaozhong Wen

Status: Completed

Conditions: Smoking, Cigarette; Breastfeeding

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05123118

UL1TR001412 (U.S. NIH Grant/Contract)

STUDY00003067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Integrated intervention

Experimental group

Description:

Integrated intervention of smoking cessation and breastfeeding

Treatment:

Behavioral: Integrated intervention of smoking cessation and breastfeeding

Attention placebo control group

Active Comparator group

Description:

Instructions on general pregnancy and infant care

Treatment:

Behavioral: Attention placebo control