Clinical trial · Interventional
Effectiveness of a Multi-Level Smoking Cessation Program for High-Risk Women in Rural Communities
Break Free: Effectiveness of a Multi-Level Smoking Cessation Program Adapted for High-Risk Women in Rural Communities
- 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)
This phase IV trial examines the effectiveness of a multi-level smoking cessation program for high-risk women in rural communities. Cigarette smoking is a major risk factor for cervical cancer in women. Rural primary care practices and providers often lack the electronic health record support to pre-identify smokers for services, as well as lack the necessary counseling training and access to comprehensive cessation programs. Implementing evidence-based smoking cessation programs in rural Appalachia may decrease the rates of cigarette smoking and as a result decrease the rates of cervical cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tobacco-Related Carcinoma | Tobacco-Related Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
| Tobacco Cessation Counseling | Other | — | UNRESOLVED |
| Training | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (early arm)
- description
- Providers undergo training over 60 minutes to explain the Break Free program and basics of quitting smoking during months 13-24. Female smokers interested in quitting in the next 6 months will be referred to an in-person counseling session at the clinic. Participants then receive 4 phone counseling over 15-20 minutes with a trained tobacco treatment specialist.
- interventionNames
- Other: Survey Administration
- Other: Tobacco Cessation Counseling
- Other: Training
- type
- ACTIVE_COMPARATOR
- label
- Arm II (delayed arm)
- description
- Female smokers receive usual care during months 13-24. Providers undergo training over 60 minutes to explain the Break Free program and basics of quitting smoking during months 25-36. Female smokers interested in quitting in the next 6 months will be referred to an in-person counseling session at the clinic. Participants then receive 4 phone counseling over 15-20 minutes with a trained tobacco treatment specialist.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * HEALTH SYSTEM/CLINIC * Based in one of the Appalachian regions included in this program project * Provides care to female smokers * PROVIDER * Practicing in one of the participating health systems * Involved in patient care * PATIENT * Females * Age 18 to 64 * Smokers who consume at least 5 cigarettes per day (less than the minimum in most cessation studies, yet still enough to show signs of nicotine dependence) * Ready to quit smoking in the next 6 months * English-speaking * Able to participate in counseling * Willing to try smoking cessation pharmacotherapy * Not pregnant
References
Publications (1)
- DERIVEDPatterson JG, Borger TN, Burris JL, Conaway M, Klesges R, Ashcraft A, Hauser L, Clark C, Wright L, Cooper S, Smith MC, Dignan M, Kennedy-Rea S, Paskett ED, Anderson R, Ferketich AK. A cluster randomized controlled trial for a multi-level, clinic-based smoking cessation program with women in Appalachian communities: study protocol for the "Break Free" program. Addict Sci Clin Pract. 2022 Feb 14;17(1):11. doi: 10.1186/s13722-022-00295-5. PMID 35164857