Enhancing Long-Term Smoking Abstinence Among Cervical Cancer Survivors (Project ACCESS)

Study Overview
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Brief Summary
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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.

Official Title
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Enhancing Long-Term Smoking Abstinence Among Cervical Cancer Survivors (Project ACCESS)

Conditions
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Smoking Cessation, Cervical Cancer, High Grade Cervical Dysplasia

Intervention / Treatment
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* Behavioral: Smoking Cessation treatment delivered by Tobacco Free Florida Quitline
* Drug: Nicotine patch
* Drug: Nicotine Lozenge
* Behavioral: Motivation and Problem Solving (MAPS) intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: Standard Treatment<br>Participants will receive a connection to the Tobacco Free Florida Quitline and a 12 week supply of nicotine replacement therapy (the patch and lozenges) | Behavioral: Smoking Cessation treatment delivered by Tobacco Free Florida Quitline<br>* Phone counseling with the state tobacco quitline<br>Drug: Nicotine patch<br>* Participants will be provided with a 12 week supply of nicotine patches<br>Drug: Nicotine Lozenge<br>* Participants will be provided with a 12 week supply of nicotine lozenges<br>|
| Experimental: Group 2: Motivation and Problem Solving (MAPS) counseling<br>Participants will receive a 12 week supply of nicotine replacement therapy (the patch and lozenges) along with the MAPS intervention, which consists of 6 MAPS counseling calls over 12 months, and individually tailored SMS text content driven by monthly smartphone delivered check-ins for 24 months | Drug: Nicotine patch<br>* Participants will be provided with a 12 week supply of nicotine patches<br>Drug: Nicotine Lozenge<br>* Participants will be provided with a 12 week supply of nicotine lozenges<br>Behavioral: Motivation and Problem Solving (MAPS) intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAPS vs Standard Treatment in facilitating long term smoking abstinence | 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. | at 24 months |