Phase 2 N=49 Randomized Supportive Care

Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors

Smoking Cessation · Social Stress

Bottom Line

View on ClinicalTrials.gov: NCT03316170 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcome: Primary: Accrual Percentage — 8.9 percentage of participants enrolled

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Social Support (Behavioral); NRT Sampling (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Jessica Burris
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Accrual Percentage	8.9	—
PRIMARY Retention	70.8; 72.0	—
PRIMARY Acceptability	2.84; 1.98	.06

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 resources, and 2) To assess the effectiveness of said treatment for key events in the process of smoking cessation.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03316170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.