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

Phase 2

Completed

Conditions: Smoking Cessation
Social Stress

Interventions: Behavioral: Social Support
Drug: NRT Sampling

Registration Number: NCT03316170

Lead Sponsor: Jessica Burris

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 49

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social Support	Social Support	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,
Social Support + NRT Sampling	Social Support	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.
Social Support + NRT Sampling	NRT Sampling	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.

Primary Outcome Measures

Name	Time	Method
Acceptability	Day 60 follow-up	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.
Accrual Percentage	Day 0 baseline	Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100
Retention	Through study completion, number of assessments at Day 60 follow-up	Retention percentage = (number with complete assessments at end of study / number participants enrolled) multiplied by 100