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Smoking Cessation Support for Cervical Cancer Survivors
N/A
Recruiting
Led By Jennifer Vidrine, PhD, MS
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 months
Awards & highlights
Study Summary
This trial will compare two different methods to help people with cervical cancer quit smoking: telephone counseling and personalized texts.
Who is the study for?
This trial is for individuals in Florida who have a history of cervical cancer or high-grade cervical dysplasia, currently smoke cigarettes, and have smoked at least 100 in their lifetime. They must speak English and own a working smartphone. People can't join if they live with someone already enrolled, cannot use nicotine replacement due to medical reasons, or are undergoing other tobacco treatments.Check my eligibility
What is being tested?
The study tests the effectiveness of combining MAPS-based telephone counseling with tailored text messages versus standard quitline smoking cessation treatment. Participants will receive either nicotine patches or lozenges as part of their therapy.See study design
What are the potential side effects?
Potential side effects from the interventions may include skin irritation from nicotine patches, mouth problems like soreness or hiccups from lozenges, and possible withdrawal symptoms such as irritability, cravings, or difficulty concentrating when quitting smoking.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MAPS vs Standard Treatment in facilitating long term smoking abstinence
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 2: Motivation and Problem Solving (MAPS) counselingExperimental Treatment3 Interventions
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
Group II: Group 1: Standard TreatmentActive Control3 Interventions
Participants will receive a connection to the Tobacco Free Florida Quitline and a 12 week supply of nicotine replacement therapy (the patch and lozenges)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine patch
2015
Completed Phase 4
~7450
Nicotine Lozenge
2005
Completed Phase 4
~300
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,135 Total Patients Enrolled
James and Esther King Biomedical Research ProgramOTHER
13 Previous Clinical Trials
1,474 Total Patients Enrolled
Jennifer Vidrine, PhD, MSPrincipal InvestigatorMoffitt Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently getting treatment to help me stop smoking.I have had cervical cancer or severe cervical pre-cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2: Motivation and Problem Solving (MAPS) counseling
- Group 2: Group 1: Standard Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial presently recruiting participants?
"Yes, the information hosted on clinicaltrials.gov verifies that this research project is presently seeking patients. This trial was first reported on November 17th 2022 and has been updated as recently as December 1st 2022. 360 participants are required to be enrolled from a single location."
Answered by AI
How many participants have been incorporated into this experiment?
"Affirmative. Information hosted on clinicaltrials.gov reveals that the trial - first posted November 17th 2022 - is actively seeking 360 participants from a single location."
Answered by AI
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