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Smoking Cessation for Cervical Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02157610
Recruitment Status : Active, not recruiting
First Posted : June 6, 2014
Last Update Posted : July 28, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Tobacco Use Smoking Cessation Behavioral: Self-Help Materials Drug: Nicotine Patch Behavioral: REDCap Procedure: Saliva Test Behavioral: Telephone Counseling Sessions Drug: Nicotine lozenge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Smoking Cessation for Cervical Cancer Survivors in a Safety Net Healthcare System
Actual Study Start Date : January 2015
Actual Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard Treatment (ST)
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.
Behavioral: Self-Help Materials
Participants receive free self-help materials mailed at baseline, 6, and 12 months. and a referral to the Oklahoma Quitline.
Other Name: Pamphlets

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.
Other Name: Surveys

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

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

Experimental: Motivation + Problem Solving (MAPS)
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.
Behavioral: Self-Help Materials
Participants receive free self-help materials mailed at baseline, 6, and 12 months. and a referral to the Oklahoma Quitline.
Other Name: Pamphlets

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.
Other Name: Surveys

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.




Primary Outcome Measures :
  1. Smoking Abstinence [ Time Frame: 18 months ]
    To test treatment effect at 18 months, logistic regression analysis conducted with abstinence as outcome variable, and treatment (a two-level categorical variable) as predictor, adjusting for covariates, specifically, factors used in the minimization procedures (race/ethnicity, language, age, education, income, cigarettes/day, cervical cancer stage, and time since diagnosis). A logit link and binomial variance function assumed for generalized linear mixed model (GLMM), regression and parameterize them with blocking on individual nested within treatment conditions. Treatment and time included, as well as their interaction, with adjustment for relevant covariates.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Self-reported current smoker
  3. History of cervical cancer or high-grade cervical dysplasia
  4. Has a working telephone number
  5. Has a valid home address
  6. Speaks English, Spanish or both languages

Exclusion Criteria:

  1. Current use of tobacco cessation medications
  2. Self-report of being pregnant or lactating
  3. Another household member enrolled in the study
  4. Contraindication for nicotine patch use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157610


Locations
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United States, Florida
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Oklahoma
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jennifer Vidrine, PHD H. Lee Moffitt Cancer Center and Research Institute
  Study Documents (Full-Text)

Documents provided by H. Lee Moffitt Cancer Center and Research Institute:
Informed Consent Form  [PDF] September 5, 2019

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02157610    
Other Study ID Numbers: MCC-20134
R01CA172786 ( U.S. NIH Grant/Contract )
NCI-2015-00067 ( Registry Identifier: NCI CTRP )
2014-0204 ( Other Identifier: Oklahoma University Health Services Center )
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Cervical Cancer
Cervical Cancer Survivors
Smoking Cessation
Motivation And Problem-Solving
MAPS
Saliva test
Self help materials
Pamphlets
Texas Quitline
Nicotine patch
Questionnaires
Surveys
Telephone counseling sessions
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action