Smoking Cessation for Cervical Cancer Survivors

NCT02157610 | Completed Results

• 4 other identifiers: MCC-20134R01CA172786NCI-2015-000672014-0204
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 3

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.

Conditions

Cervical Cancer; Tobacco Use; Smoking Cessation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Smoking Abstinence

  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.

  18 months

Study Arms (2)

Standard Treatment (ST)

EXPERIMENTAL

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; Drug: Nicotine Patch; Behavioral: REDCap; Procedure: Saliva Test; Drug: Nicotine lozenge

Motivation + Problem Solving (MAPS)

EXPERIMENTAL

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; Drug: Nicotine Patch; Behavioral: REDCap; Procedure: Saliva Test; Behavioral: Telephone Counseling Sessions; Drug: Nicotine lozenge

Interventions

Self-Help Materials BEHAVIORAL

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

Also known as: Pamphlets

Motivation + Problem Solving (MAPS); Standard Treatment (ST)

Nicotine Patch DRUG

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.

Motivation + Problem Solving (MAPS); Standard Treatment (ST)

REDCap BEHAVIORAL

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.

Also known as: Surveys

Motivation + Problem Solving (MAPS); Standard Treatment (ST)

Saliva Test PROCEDURE

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

Motivation + Problem Solving (MAPS); Standard Treatment (ST)

Telephone Counseling Sessions BEHAVIORAL

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

Motivation + Problem Solving (MAPS)

Nicotine lozenge DRUG

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

Motivation + Problem Solving (MAPS); Standard Treatment (ST)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Self-reported current smoker
• History of cervical cancer or high-grade cervical dysplasia
• Has a working telephone number
• Has a valid home address
• Speaks English, Spanish or both languages

You may not qualify if:

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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (2)

• Vidrine JI, Sutton SK, Wetter DW, Shih YT, Ramondetta LM, Elting LS, Walker JL, Smith KM, Frank-Pearce SG, Li Y, Jones SR, Kendzor DE, Simmons VN, Vidrine DJ. Efficacy of a Smoking Cessation Intervention for Survivors of Cervical Intraepithelial Neoplasia or Cervical Cancer: A Randomized Controlled Trial. J Clin Oncol. 2023 May 20;41(15):2779-2788. doi: 10.1200/JCO.22.01228. Epub 2023 Mar 15.

  PMID: 36921237 BACKGROUND

• Jones SR, Vidrine DJ, Wetter DW, Shih YT, Sutton SK, Ramondetta LM, Elting LS, Walker JL, Smith KM, Frank-Pearce SG, Li Y, Simmons VN, Vidrine JI. 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 Res Protoc. 2021 Dec 30;10(12):e34502. doi: 10.2196/34502.

  PMID: 34967755 BACKGROUND

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Tobacco Use; Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Jennifer Vidrine, PhD, MS
• Organization: Moffitt Cancer Center

jennifer.vidrine@moffitt.org

813-745-8764

Study Officials

• Jennifer Vidrine, PHD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 6, 2014
• Study Start: January 1, 2015
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: July 20, 2023
• Results First Posted: April 12, 2023

Record last verified: 2023-02

Locations

US (3)