Clinical trial NCT03316170: Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors
Official title: Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Social Stress
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Kentucky Lung Cancer Research Program
First posted: 2017-10-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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 that may help them address unmet social support needs. Additionally, a written directory of a range of social support resources will be delivered to them via mail. The treatment group will receive the aforesaid intervention plus brief advice to quit smoking (10-15 minutes via phone). Additionally, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) will be provided via mail. The treatment group will also receive a free, 2-week supply of nicotine patches and lozenges delivered via mail. As a pilot, this study focuses on the outcomes of feasibility (i.e., accrual and retention) and acceptability (e.g., participants' perceptions of appropriateness and effectiveness) as opposed to efficacy (though this is also important). The emphasis on smoking cessation induction (that is, the inducement or promotion of a quit attempt) is an important aspect of the study design and is appropriate for smokers across the continuum of motivation to quit.

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

Primary outcomes:
measure: Accrual Percentage
timeFrame: Day 0 baseline
measure: Retention
timeFrame: Through study completion, number of assessments at Day 60 follow-up
measure: Acceptability
timeFrame: Day 60 follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jessica Burris, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sidani 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.