Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/27/2018 |
| Start Date: | November 6, 2017 |
| End Date: | July 31, 2030 |
| Contact: | Jessica Burris, Ph.D. |
| Email: | jessica.burris@uky.edu |
| Phone: | 859-218-4092 |
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.
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.
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.
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.
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
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