Smoking Cessation for Cervical Cancer Survivors
NCT02157610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202
Last updated 2023-07-20
Summary
The goal of this research study is to compare a program called Motivation And Problem-Solving (MAPS) to the standard treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking.
Conditions
- Cervical Cancer
- Tobacco Use
- Smoking Cessation
Interventions
- BEHAVIORAL
-
Self-Help Materials
Participants receive free self-help materials mailed at baseline, 6, and 12 months. and a referral to the Oklahoma Quitline.
- DRUG
-
Nicotine Patch
Participants receive a 12-week supply of nicotine patch. Nicotine patch regime based on participant's self-reported smoking rate. Participants who smoke \>10 cigarettes/day receive 8 weeks of 21 mg, 2 week of 14 mg, and 2 week of 7 mg patches. Those who smoke \<10 cigarettes/day receive 8 weeks of 14 mg and 4 weeks of 7 mg patches.
- BEHAVIORAL
-
REDCap
REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months.
- PROCEDURE
-
Saliva Test
Saliva test performed at 3, 6, 12, and 18 months.
- BEHAVIORAL
-
Telephone Counseling Sessions
6 telephone counseling sessions performed over 12 months. Sessions performed at baseline, 3, 6, 12, and 18 months. Sessions digitally recorded.
- DRUG
-
Nicotine lozenge
Participants receive a 12-week supply of nicotine lozenges. All participants receive 12 weeks of 2mg lozenges.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
H. Lee Moffitt Cancer Center and Research Institute
lead OTHER
Principal Investigators
-
Jennifer Vidrine, PHD · H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2021-08-31
- Completion
- 2021-08-31
Countries
- United States
Study Locations
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