CompletedNot Applicable

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

United States40 participantsStarted 2021-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Smoking Abstinence

Timeframe: 6 months postpartum

Number of Participants With Reported Intent to Breastfeed

Timeframe: 35 weeks of pregnancy (the end of pregnancy)

Number of Participants Reporting to Breastfeed

Timeframe: 6 months postpartum

Trial details

NCT IDNCT05123118

SponsorXiaozhong Wen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-30

Results submitted2025-03-17

View on ClinicalTrials.gov More Smoking, Cigarette trials