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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645146
• Other study ID #: MCC-21885
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2022
• Est. completion date: November 2025

Study information

• Verified date: March 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Sarah Jones
• Phone: 813-745-7525
• Email: Sarah.Jones[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• High Grade Cervical Dysplasia
• Smoking Cessation
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	James and Esther King Biomedical Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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