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

NCT ID: NCT05645146

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-29

Study Completion Date

2028-01-31

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.

Detailed Description

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Conditions

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Smoking Cessation Cervical Cancer High Grade Cervical Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1: Standard Treatment

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 Type ACTIVE_COMPARATOR

Smoking Cessation treatment delivered by Tobacco Free Florida Quitline

Intervention Type BEHAVIORAL

Phone counseling with the state tobacco quitline

Nicotine patch

Intervention Type DRUG

Participants will be provided with a 12 week supply of nicotine patches

Nicotine Lozenge

Intervention Type DRUG

Participants will be provided with a 12 week supply of nicotine lozenges

Group 2: Motivation and Problem Solving (MAPS) counseling

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 Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

Participants will be provided with a 12 week supply of nicotine patches

Nicotine Lozenge

Intervention Type DRUG

Participants will be provided with a 12 week supply of nicotine lozenges

Motivation and Problem Solving (MAPS) intervention

Intervention Type 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.

Interventions

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Smoking Cessation treatment delivered by Tobacco Free Florida Quitline

Phone counseling with the state tobacco quitline

Intervention Type BEHAVIORAL

Nicotine patch

Participants will be provided with a 12 week supply of nicotine patches

Intervention Type DRUG

Nicotine Lozenge

Participants will be provided with a 12 week supply of nicotine lozenges

Intervention Type DRUG

Motivation 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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James and Esther King Biomedical Research Program

OTHER

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Vidrine, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37403057 (View on PubMed)

Other Identifiers

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MCC-21885

Identifier Type: -

Identifier Source: org_study_id

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