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

NCT05645146 | Active Not Recruiting

• 1 other identifier: MCC-21885
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Cervical Cancer; High Grade Cervical Dysplasia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1: Standard Treatment

ACTIVE COMPARATOR

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; Drug: Nicotine patch; Drug: Nicotine Lozenge

Group 2: Motivation and Problem Solving (MAPS) counseling

EXPERIMENTAL

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; Drug: Nicotine Lozenge; Behavioral: Motivation and Problem Solving (MAPS) intervention

Interventions

Nicotine patch DRUG

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

Group 1: Standard Treatment; Group 2: Motivation and Problem Solving (MAPS) counseling

Nicotine Lozenge DRUG

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

Group 1: Standard Treatment; Group 2: Motivation and Problem Solving (MAPS) counseling

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.

Group 2: Motivation and Problem Solving (MAPS) counseling

Smoking Cessation treatment delivered by Tobacco Free Florida Quitline BEHAVIORAL

Phone counseling with the state tobacco quitline

Group 1: Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: cervical cancer or cervical dysplasia patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• James and Esther King Biomedical Research Program: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Uterine Cervical Neoplasms

Interventions

Tobacco Use Cessation Devices; Methods

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Jennifer Vidrine, PhD, MS

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: November 29, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)