CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 202 enrolled
Drug / intervention
Nicotine Patch +5 moredrug
Likely dose
Nicotine Patch 21 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02157610
NCT02157610N/ACompleted

Smoking Cessation for Cervical Cancer Survivors in a Safety Net Healthcare System

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Jun 6, 2014·Updated Jul 20, 2023

In Brief

A clinical study evaluating Self-Help Materials, Nicotine Patch, and 4 other interventions for Cervical Cancer and 2 related conditions. Completed, enrolled 202 participants across 3 sites.

Detailed Summary

The goal of this research study is to compare a program called Motivation And Problem-Solving (MAPS) to the standard treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 6, 2014
Enrollment StartJan 1, 2015
Primary CompletionAug 1, 2021
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 12.1 years ago

Interventions

Self-Help Materialsbehavioral

Participants receive free self-help materials mailed at baseline, 6, and 12 months. and a referral to the Oklahoma Quitline.

Nicotine Patchdrug

Participants receive a 12-week supply of nicotine patch. Nicotine patch regime based on participant's self-reported smoking rate. Participants who smoke \>10 cigarettes/day receive 8 weeks of 21 mg, 2 week of 14 mg, and 2 week of 7 mg patches. Those who smoke \<10 cigarettes/day receive 8 weeks of 14 mg and 4 weeks of 7 mg patches.

REDCapbehavioral

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 Testprocedure

Saliva test performed at 3, 6, 12, and 18 months.

Telephone Counseling Sessionsbehavioral

6 telephone counseling sessions performed over 12 months. Sessions performed at baseline, 3, 6, 12, and 18 months. Sessions digitally recorded.

Nicotine lozengedrug

Participants receive a 12-week supply of nicotine lozenges. All participants receive 12 weeks of 2mg lozenges.