Back to resultsSmoking Cessation in Women With Gynecological Conditions
Primary Purpose
Cervical Dysplasia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine Replacement Therapy
Electronic Cigarettes
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dysplasia focused on measuring Smoking cessation, Traditional nicotine replacement therapy, Electronic nicotine delivery devices, electronic cigarettes, cervical dysplasia
Eligibility Criteria
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.
Sites / Locations
- Stephenson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nicotine replacement therapy
Electronic Cigarettes
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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:
Reduction of number of cigarettes smoked per day.
Point prevalence abstinence at 7 and 30 days
Smoking cessation rates
Qualitative interviews to assess positives and negatives in these two smoking cessation methods.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01989923
Brief Title
Smoking Cessation in Women With Gynecological Conditions
Official Title
Immediate Smoking Cessation for Patients at Risk for Cervical Dysplasia, Cervical Cancer and Lower Genital Tract Dysplasia and Cancer - A Feasibility Study Comparing Nicotine Replacement Therapy With the Electronic Nicotine Delivery System.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
April 13, 2017 (Actual)
Study Completion Date
April 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dysplasia
Keywords
Smoking cessation, Traditional nicotine replacement therapy, Electronic nicotine delivery devices, electronic cigarettes, cervical dysplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nicotine replacement therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Electronic Cigarettes
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nicotine Replacement Therapy
Other Intervention Name(s)
Nicoderm CQ patches (21 or 14 mg patches), Nicorette gum (2 mg), Nicorette lozenges (2 mg)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Electronic Cigarettes
Other Intervention Name(s)
Blu Cig Electronic Nicotine Delivery System
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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:
Reduction of number of cigarettes smoked per day.
Point prevalence abstinence at 7 and 30 days
Smoking cessation rates
Qualitative interviews to assess positives and negatives in these two smoking cessation methods.
Time Frame
We plan a 3-month study with 6 week follow-up periods.
Secondary Outcome Measure Information:
Title
Feasibility of Study
Description
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.
Time Frame
3 months with 6 week follow-up windows
Other Pre-specified Outcome Measures:
Title
Product Adherence Diary
Description
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.
Time Frame
Women fill out diary every day for 12 weeks
Title
Composite set of semi-structured interviews
Description
We will use semi-structured interviews at the 12 week follow-up to help us understand:
If the woman currently feels she has a healthy or unhealthy lifestyle, and what factors contribute to this answer.
What smoking cessation methods the women have tried in the past, if the methods were acceptable, if they worked, and why or why not.
Barriers that might make it difficult for women with this diagnosis to quit smoking using the device they tried in the study.
Assists that might make it easier for women with this diagnosis to quit smoking using the device they tried in the study.
How the women feel about continuing to use the device that they tried in the trial.
Risks the women feel they are taking if they continue to use NRT, ENDS, or decide to return to smoking.
What about smoking makes it worth or not worth the risk to these women personally.
Time Frame
done at the end of the study (at 12-weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Beebe, PhD
Organizational Affiliation
University of Oklahoma Health Sciences Center, College of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Smoking Cessation in Women With Gynecological Conditions
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