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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Smoking Cessation, Social Stress

Intervention / Treatment
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* Behavioral: Social Support
* Drug: NRT Sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social Support + NRT Sampling<br>The treatment group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, a written directory of a range of social support resources delivered via mail, a brief phone consult (10-15 minutes via phone) germane to smoking cessation, 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 a free, 2-week supply of nicotine patches and lozenges delivered via mail. | Behavioral: Social Support<br>* A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.<br>Drug: NRT Sampling<br>* A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to brief advice, 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 a free, 2-week supply of nicotine patches and lozenges delivered via mail.<br>|
| Active Comparator: Social Support<br>The control group will receive: a brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, a written directory of a range of social support resources delivered via mail, | Behavioral: Social Support<br>* A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accrual Percentage | Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100 | Day 0 baseline | 
| Retention | Retention percentage = (number with complete assessments at end of study / number participants enrolled) multiplied by 100 | Through study completion, number of assessments at Day 60 follow-up | 
| Acceptability | Total score on the Treatment Acceptability and Preferences measure (Sidani et al., 2009). This is a 4-item measure with each item scored on a scale from 0 to 4. Total scores are computed as the mean of the 4 individual items, so total scores range from 0 to 4. Higher scores indicate a better outcome, as they reflect greater acceptability of the treatment provided in this clinical trial. | Day 60 follow-up |