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

Primary Purpose

Smoking Cessation, Cervical Cancer, High Grade Cervical Dysplasia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smoking Cessation treatment delivered by Tobacco Free Florida Quitline
Nicotine patch
Nicotine Lozenge
Motivation and Problem Solving (MAPS) intervention
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1: Standard Treatment

Group 2: Motivation and Problem Solving (MAPS) counseling

Arm Description

Participants will receive a connection to the Tobacco Free Florida Quitline and a 12 week supply of nicotine replacement therapy (the patch and lozenges)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 1, 2022
Last Updated
October 17, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
James and Esther King Biomedical Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT05645146
Brief Title
Enhancing Long-Term Smoking Abstinence Among Cervical Cancer Survivors (Project ACCESS)
Official Title
Enhancing Long-Term Smoking Abstinence Among Cervical Cancer Survivors (Project ACCESS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
James and Esther King Biomedical Research Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Cervical Cancer, High Grade Cervical Dysplasia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Standard Treatment
Arm Type
Active Comparator
Arm Description
Participants will receive a connection to the Tobacco Free Florida Quitline and a 12 week supply of nicotine replacement therapy (the patch and lozenges)
Arm Title
Group 2: Motivation and Problem Solving (MAPS) counseling
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Smoking Cessation treatment delivered by Tobacco Free Florida Quitline
Intervention Description
Phone counseling with the state tobacco quitline
Intervention Type
Drug
Intervention Name(s)
Nicotine patch
Intervention Description
Participants will be provided with a 12 week supply of nicotine patches
Intervention Type
Drug
Intervention Name(s)
Nicotine Lozenge
Intervention Description
Participants will be provided with a 12 week supply of nicotine lozenges
Intervention Type
Behavioral
Intervention Name(s)
Motivation and Problem Solving (MAPS) intervention
Intervention Description
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 Outcome Measure Information:
Title
MAPS vs Standard Treatment in facilitating long term smoking abstinence
Description
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.
Time Frame
at 24 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
cervical cancer or cervical dysplasia patients
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Jones
Phone
813-745-7525
Email
Sarah.Jones@moffitt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Vidrine, PhD, MS
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Jones
Phone
813-745-7525
Email
Sarah.Jones@moffitt.org
First Name & Middle Initial & Last Name & Degree
Jennifer Vidrine, PhD, MS
First Name & Middle Initial & Last Name & Degree
Damon Vidrine, DrPH, MS
First Name & Middle Initial & Last Name & Degree
Steven Sutton, PhD
First Name & Middle Initial & Last Name & Degree
Vani Simmons, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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