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

March 27, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Jennifer Vidrine, PhD, MS
        • Sub-Investigator:
          • Damon Vidrine, DrPH, MS
        • Sub-Investigator:
          • Steven Sutton, PhD
        • Sub-Investigator:
          • Vani Simmons, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Behavioral: Smoking Cessation treatment delivered by Tobacco Free Florida Quitline
Phone counseling with the state tobacco quitline
Drug: Nicotine patch
Participants will be provided with a 12 week supply of nicotine patches
Drug: Nicotine Lozenge
Participants will be provided with a 12 week supply of nicotine lozenges
Experimental: 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
Drug: Nicotine patch
Participants will be provided with a 12 week supply of nicotine patches
Drug: Nicotine Lozenge
Participants will be provided with a 12 week supply of nicotine lozenges
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

James and Esther King Biomedical Research Program

Investigators

  • Principal Investigator: Jennifer Vidrine, PhD, MS, Moffitt Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2022

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-21885

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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