Smoking Cessation in Women With Gynecological Conditions (NCT01989923) | Clinical Trial Compass
CompletedNot Applicable
Smoking Cessation in Women With Gynecological Conditions
United States31 participantsStarted 2013-06
Plain-language summary
This feasibility study will compare two smoking cessation methods, traditional nicotine replacement therapy and Electronic Nicotine Delivery Systems (electronic cigarettes) in patients with gynecological conditions.
Who can participate
Age range
18 Years – 65 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:
* Female
* Smokers (defined as those who have smoked at least daily for the last year and who have smoked greater than or equal to 10 or more combustible cigarettes per day during the last year.
* Patients with diagnoses of Cervical Dysplasia, Cervical Cancer and Lower Genital Tract Dysplasia and Cancer
* Ages 18-65 years
Exclusion Criteria:
* Patients unwilling to commit to a 6-week intervention that may include either NRT or ENDS.
* Patients with previous diagnoses of or treatment for cancer - with the exception of non-melanoma skin cancer.
* Presence of any known stroke, heart disease, heart attack, or irregular heart beat.
* Pregnancy and lactation.
* Plan to continue to use other nicotine in addition to the products supplied by the study. These would include: chewing tobacco, snuff, an additional nicotine patch or other nicotine containing products.
* High blood pressure, not well controlled with medication.
* Patients using a non-nicotine "smoking cessation medication."
* Patients taking a prescription medicine for depression or asthma.
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
1
Composite set of questions about the feasibility of successfully using NRT and ENDS over time (assessing change in smoking habits) in Women with Serious Gynecological Conditions
Timeframe: We plan a 3-month study with 6 week follow-up periods.