Status:
COMPLETED
Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors
Lead Sponsor:
Jessica Burris
Collaborating Sponsors:
Kentucky Lung Cancer Research Program
Conditions:
Smoking Cessation
Social Stress
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 resourc...
Detailed Description
This is a pilot (Phase II) randomized clinical trial with randomization in a 1:1 ratio. The control group will receive a brief consultation (10-15 minutes via phone) about free or low-cost resources t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03316170
Start Date
November 6 2017
End Date
March 31 2020
Last Update
July 8 2021
Active Locations (1)
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1
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States, 40536