Clinical trial · Interventional
Smoking Cessation for Cervical Cancer Survivors
Smoking Cessation for Cervical Cancer Survivors in a Safety Net Healthcare System
NCT02157610CI-TRIAL-00068126completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Smoking Cessation | — | UNRESOLVED | — |
| Tobacco Use | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nicotine lozenge | Drug | — | UNRESOLVED |
| Nicotine Patch | Drug | — | UNRESOLVED |
| REDCap | Behavioral | — | UNRESOLVED |
| Saliva Test | Procedure | — | UNRESOLVED |
| Self-Help Materials | Behavioral | — | UNRESOLVED |
| Telephone Counseling Sessions | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Standard Treatment (ST)
- description
- 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.
- interventionNames
- Behavioral: Self-Help Materials
- Drug: Nicotine Patch
- Behavioral: REDCap
- Procedure: Saliva Test
- Drug: Nicotine lozenge
- type
- EXPERIMENTAL
- label
- Motivation + Problem Solving (MAPS)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDVidrine 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
- BACKGROUNDJones 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