Smoking Cessation for Cervical Cancer Survivors

NCT02157610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2023-07-20

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Self-Help Materials

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

DRUG

Nicotine Patch

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.

BEHAVIORAL

REDCap

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.

PROCEDURE

Saliva Test

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

BEHAVIORAL

Telephone Counseling Sessions

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

DRUG

Nicotine lozenge

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jennifer Vidrine, PHD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02157610 on ClinicalTrials.gov