Clinical trial · Interventional
Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors
NCT03316170CI-TRIAL-00052594completedPhase 2Results 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 objectives of this pilot clinical trial are: 1) To evaluate the feasibility and acceptability of a new approach to smoking cessation induction treatment in cancer survivors with low social resources, and 2) To assess the effectiveness of said treatment for key events in the process of smoking cessation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Smoking Cessation | — | UNRESOLVED | — |
| Social Stress | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NRT Sampling | Drug | — | UNRESOLVED |
| Social Support | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Social Support + NRT Sampling
- description
- The treatment group will receive: 1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, 2. a written directory of a range of social support resources delivered via mail, 3. a brief phone consult (10-15 minutes via phone) germane to smoking cessation, 4. a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and 5. a free, 2-week supply of nicotine patches and lozenges delivered via mail.
- interventionNames
- Behavioral: Social Support
- Drug: NRT Sampling
- type
- ACTIVE_COMPARATOR
- label
- Social Support
- description
- The control group will receive: 1. a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, 2. a written directory of a range of social support resources delivered via mail,
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Cervical or head/neck cancer diagnosis in the past 5 years * Resident of rural and/or Appalachian Kentucky county at cancer diagnosis * Current smoker of ≥ 10 cigarettes per day, on average * Age 18-75 years old * Able to read, write, and understand English Exclusion Criteria: * Unreliable phone access * Smoking cessation treatment use in past 30 days * Non-cigarette tobacco use in the past 30 days * Any FDA contraindication for NRT use, including: allergy to nicotine patches and/or nicotine lozenges; severe kidney or liver disease; unstable angina or serious arrhythmia; epilepsy or seizure disorder; myocardial infarction in the past 3 months * Cognitive or psychiatric disorder that would interfere with ability to provide informed consent or answer survey questions reliably \* \* Any of these Diagnostic and Statistical Manual-5 (DSM-5) cognitive and psychiatric disorders would make someone ineligible: bipolar; delusional; dissociative; intellectual developmental; neurocognitive; psychotic; schizophreniform, schizophrenia, and schizoaffective. * For women: breastfeeding, pregnancy, or plan to become pregnant within 6 months * For women of childbearing potential: unwillingness to use an effective method of birth control (e.g., abstinence, oral contraceptive) while in this study
References
Publications (1)
- BACKGROUNDSidani S, Epstein DR, Bootzin RR, Moritz P, Miranda J. Assessment of preferences for treatment: validation of a measure. Res Nurs Health. 2009 Aug;32(4):419-31. doi: 10.1002/nur.20329. PMID 19434647