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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.
This study will allow women with serious gynecological conditions to sample both traditional nicotine replacement therapy (NRT) and Electronic Nicotine Delivery Systems (electronic cigarettes, ENDS). Whether the woman samples NRT or ENDS first will be randomized. Women will choose the product they wish to try for a 6-week intervention period for smoking cessation. Women choosing NRT will receive a 6-week intervention of a daily nicotine patch plus either nicotine gum or lozenges to use (as needed) throughout the day. The ENDS group will receive an electronic cigarette device with refills to last the 6-week duration of the study. Both groups will receive identical tobacco cessation counseling. As part of the study, each subject will complete a survey conducted at baseline, 6-weeks into the study during intervention, and upon completion of a 6 week follow-up period in which participants receive no intervention. At the 12-week measurement period we will add a qualitative interview that will allow us to ask the women whether the methods were acceptable, caused any problems, and if so, what the problems entailed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine replacement therapy | Active Comparator | Women in this arm of the study will receive 24-hour Nicotine Patches - either 21 mg patches (for 1 pack per day smokers), or 14 mg patches (for 1/2 pack per day smokers) smokers). Patients will use one patch per day for 6 weeks for a total of 42 patches. Women will receive 3 weeks of original strength nicotine patches, and will receive patches half as strong during the last 3 weeks of the study. This will allow for a lower strength of nicotine as each woman continues with smoking cessation. Women will also receive nicotine gum or lozenges (subject choice)- these will be 2 mg pieces of nicotine gum or lozenge (approximately 210 pieces). This will account for using 8-10 per day at the beginning of the study and tapering to 2-3 pieces per day by the end of the study. |
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| Electronic Cigarettes | Active Comparator | Women in this arm of the study will receive one "Blu Cig" Electronic Nicotine Delivery Device (E-cigarette) along with 2 electronic cigarette batteries, 1 wall charger and 1 USB charger, cartridges/refills in menthol or regular (patient choice). The number of cartridges is determined by asking each patient the number of packs currently smoked per day, and multiplying 1.5 times the number of packs smoked per day. We plan to decrease the strength of the cartridges by one half after three weeks of intervention. We will give each women supplies and instructions accordingly. This will allow for a lower strength of nicotine as each woman continues with smoking cessation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Replacement Therapy | Other | Patients will use one patch per day for 6 weeks for a total of 42 patches - they will receive 7 the first visit and then the additional 35 at the second visit. Women will receive 3 weeks of original strength nicotine patches, and will receive patches half as strong during the last 3 weeks of the study. This will allow for a lower strength of nicotine as each woman continues with smoking cessation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | To determine the acceptability of traditional nicotine replacement therapy (nicotine patch plus nicotine gum or lozenges) and the ENDS (electronic nicotine delivery system or electronic cigarette as smoking cessation tools in a group of women with cervical dysplasia from the Stephenson Cancer Center Dysplasia Clinics. Measurements to assess success:
| We plan a 3-month study with 6 week follow-up periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Study | To determine if we can accure 30 smoking women with cervical dysplasia from the Stephenson Cancer Center for smoking cessation intervention in a 6-month window. | 3 months with 6 week follow-up windows |
| Measure | Description | Time Frame |
|---|---|---|
| Product Adherence Diary | The diary will be used for the 6 week intervention portion of the study. This diary is designed to assist individuals in monitoring their smoking and product use during the study. We will encourage each subject to write down every regular cigarette that she smokes as well as every use of the product to which she has been randomized. | Women fill out diary every day for 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura A Beebe, PhD | University of Oklahoma Health Sciences Center, College of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D016540 | Smoking Cessation |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D004864 | Equipment and Supplies |
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| Electronic Cigarettes | Device | The number of cartridges for the electronic cigarettes is determined by asking each patient the number of packs currently smoked per day, and multiplying 1.5 times the number of packs smoked per day. We plan to decrease the strength of the cartridges by one half after three weeks of intervention. We will give each women supplies and instructions accordingly. This will allow for a lower strength of nicotine as each woman continues with smoking cessation |
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| Composite set of semi-structured interviews | We will use semi-structured interviews at the 12 week follow-up to help us understand:
| done at the end of the study (at 12-weeks) |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012907 | Smoking |