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

NCT05645146 — Not applicable, Active not recruiting, 360 participants, H. Lee Moffitt Cancer Center and Research Institute

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Registry	NCT05645146
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	360 (Actual)
Sponsor	H. Lee Moffitt Cancer Center and Research Institute (Other); collaborators: James and Esther King Biomedical Research Program
Conditions	Smoking Cessation, Cervical Cancer, High Grade Cervical Dysplasia
Interventions	Smoking Cessation treatment delivered by Tobacco Free Florida Quitline, Nicotine patch, Nicotine Lozenge, Motivation and Problem Solving (MAPS) intervention (Behavioral, drug)
Dates	start 2022-11-29, primary completion 2027-01-01 (estimated), completion 2028-01-01 (estimated), first posted 2022-12-09, last updated 2026-04-01
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group 1: Standard Treatment	Active comparator	Behavioral: Smoking Cessation treatment delivered by Tobacco Free Florida Quitline; Drug: Nicotine patch; Drug: 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	Experimental	Drug: Nicotine patch; Drug: Nicotine Lozenge; Behavioral: 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

Smoking Cessation treatment delivered by Tobacco Free Florida Quitline (Behavioral): Phone counseling with the state tobacco quitline
Nicotine patch (Drug): Participants will be provided with a 12 week supply of nicotine patches
Nicotine Lozenge (Drug): Participants will be provided with a 12 week supply of nicotine lozenges
Motivation and Problem Solving (MAPS) intervention (Behavioral): 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.

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Moffitt Cancer Center	Tampa, Florida	United States

+Publications

Results publication: Vidrine JI, Fennell BS, Simmons VN, Sutton SK, Jones SR, Woodward HW, Hoogland CE, Vidrine DJ. Enhancing long-term smoking abstinence among individuals with a history of cervical intraepithelial neoplasia or cervical cancer (Project ACCESS): protocol for a randomized clinical trial. BMC Public Health. 2023 Jul 4;23(1):1284. doi: 10.1186/s12889-023-16189-3. PMID 37403057

+Investigators

Jennifer Vidrine, PhD, MS, Principal investigator, Moffitt Cancer Center