Breast Cancer Clinical Trial

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

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.

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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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

40

Study ID:

NCT05123118

Recruitment Status:

Recruiting

Sponsor:

Xiaozhong Wen

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There is 1 Location for this study

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Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo
Buffalo New York, 14214, United States More Info
Xiaozhong Wen
Contact
716-829-6811
[email protected]
Xiaozhong Wen
Contact
7168296811
Xiaozhong Wen, MD, PhD
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

40

Study ID:

NCT05123118

Recruitment Status:

Recruiting

Sponsor:


Xiaozhong Wen

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