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

Not Applicable

Recruiting

• Conditions: Smoking Cessation; Cervical Cancer; High Grade Cervical Dysplasia
• Interventions: Behavioral: Smoking Cessation treatment delivered by Tobacco Free Florida Quitline; Drug: Nicotine Lozenge; Drug: Nicotine patch; Behavioral: Motivation and Problem Solving (MAPS) intervention

• Registration Number: NCT05645146
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-29
• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 360

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

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Exclusion Criteria

• Receiving behavioral or pharmacological tobacco treatment
• Household member enrolled in this study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Motivation and Problem Solving (MAPS) counseling	Nicotine Lozenge	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
Group 1: Standard Treatment	Smoking Cessation treatment delivered by Tobacco Free Florida Quitline	Participants will receive a connection to the Tobacco Free Florida Quitline and a 12 week supply of nicotine replacement therapy (the patch and lozenges)
Group 1: Standard Treatment	Nicotine patch	Participants will receive a connection to the Tobacco Free Florida Quitline and a 12 week supply of nicotine replacement therapy (the patch and lozenges)
Group 1: Standard Treatment	Nicotine Lozenge	Participants will receive a connection to the Tobacco Free Florida Quitline and a 12 week supply of nicotine replacement therapy (the patch and lozenges)
Group 2: Motivation and Problem Solving (MAPS) counseling	Nicotine patch	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
Group 2: Motivation and Problem Solving (MAPS) counseling	Motivation and Problem Solving (MAPS) intervention	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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States