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Nicotine Replacement Therapy

Telephone Counseling Sessions for Cervical Cancer

N/A
Waitlist Available
Led By Jennifer Vidrine, PHD
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 18 months
Awards & highlights

Study Summary

This trial will compare a smoking cessation program called MAPS to the standard treatment to see if it helps people with a history of cervical cancer or high-grade dysplasia quit smoking.

Eligible Conditions
  • Cervical Cancer
  • Smoking Cessation
  • Tobacco Use

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Smoking Abstinence

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard Treatment (ST)Experimental Treatment5 Interventions
Participants receive free self-help materials mailed at baseline, 6, and 12 months. Participants receive a referral to the Oklahoma Quitline. Participants receive a 12-week supply of the nicotine patch and lozenge. Nicotine patch regime based on participant's self-reported smoking rate. REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months. Saliva test performed at 3, 6, 12, and 18 months.
Group II: Motivation + Problem Solving (MAPS)Experimental Treatment6 Interventions
Participants receive free self-help materials mailed at baseline, 6, and 12 months. Participants receive a referral to the Oklahoma Quitline.Participants receive a 12-week supply of the nicotine patch and lozenge. Nicotine patch regime based on participant's self-reported smoking rate. REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months. Saliva test performed at 3, 6, 12, and 18 months. 6 telephone counseling sessions performed over 12 months. Sessions performed at baseline, 3, 6, 12, and 18 months. Sessions digitally recorded.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine Patch
2011
Completed Phase 4
~10480
REDCap
2015
N/A
~210
Saliva Test
2015
N/A
~210
Telephone Counseling Sessions
2012
N/A
~510
Nicotine lozenge
2019
Completed Phase 4
~1940
Self-Help Materials
2015
Completed Phase 3
~6950

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,290 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,871 Total Patients Enrolled
Jennifer Vidrine, PHDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
JMIR Research ProtocolsJournal
Evaluation of the Efficacy of a Smoking Cessation Intervention for Cervical Cancer Survivors and Women with High-grade Cervical Dysplasia: Protocol for a Randomized Controlled Trial
Jones, Sarah R, Damon J Vidrine, David W Wetter, Ya-Chen Tina Shih, Steven K Sutton, Lois M Ramondetta, Linda S Elting, et al.. 2021. “Evaluation of the Efficacy of a Smoking Cessation Intervention for Cervical Cancer Survivors and Women with High-grade Cervical Dysplasia: Protocol for a Randomized Controlled Trial”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/34502.
clinicaltrials.govStudy
Smoking Cessation for Cervical Cancer Survivors
2015. "Smoking Cessation for Cervical Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02157610.
~20 spots leftby Apr 2025
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