Cervical Cancer, High Grade Cervical Dysplasia, Smoking Cessation
Conditions
Brief summary
The goal of this research study is to compare the efficacy of a treatment approach that comprises both Motivation And Problem-Solving (MAPS)-based telephone counseling and a personally-tailored SMS-delivered text-based approach to quitline-delivered smoking cessation treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking.
Interventions
BEHAVIORALSmoking Cessation treatment delivered by Tobacco Free Florida Quitline
Phone counseling with the state tobacco quitline
DRUGNicotine patch
Participants will be provided with a 12 week supply of nicotine patches
DRUGNicotine Lozenge
Participants will be provided with a 12 week supply of nicotine lozenges
BEHAVIORALMotivation and Problem Solving (MAPS) intervention
MAPS is a phone counseling approach to facilitating smoking cessation among cervical cancer survivors, which uses a combined motivational interviewing and social cognitive theory based approach to smoking cessation. Participants will receive 6 MAPS based counseling calls over 12 months, along with personally-tailored SMS-delivered text based messages delivered to the participants phone over 2 years.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
James and Esther King Biomedical Research Program
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 100 cigarettes or more smoked in participants lifetime * Speaks English * Currently smoke 1 cigarette or more in the past 30 days * History of cervical cancer or high grade cervical dysplasia * Has a working smartphone * Has a valid home address * Reside in Florida at the time of study enrollment
Exclusion criteria
* Receiving behavioral or pharmacological tobacco treatment * Household member enrolled in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAPS vs Standard Treatment in facilitating long term smoking abstinence | at 24 months | The primary outcome of this study is self-reported, 7 day point prevalence abstinence over time through the 24 month assessment where participants who report no smoking in the previous 7 days at follow-up assessment are considered abstinent. Efficacy of MAPS vs Standard Treatment will be measured by comparing the number of participants in each group who were able to quit smoking and maintain smoking abstinence for 2 years. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer Vidrine, PhD, MS
Moffitt Cancer Center
Outcome results
None listed