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Active, Not Recruiting

NCT Number: NCT05645146

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Smoking Cessation Behavior Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Health Behavior High Grade Cervical Dysplasia Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. MAPS vs Standard Treatment in facilitating long term smoking abstinence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • James and Esther King Biomedical Research Program

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Dec 9, 2022
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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