Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Social Support + NRT Sampling
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.
干预措施: Social Support (Behavioral)
Social Support + NRT Sampling
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.
干预措施: NRT Sampling (Drug)
Social Support
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,
干预措施: Social Support (Behavioral)
结局指标
主要结局
Acceptability
时间窗: 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
时间窗: Day 0 baseline
Accrual percentage = (number participants enrolled / number individuals contacted about study participation) multiplied by 100
Retention
时间窗: 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
次要结局
未报告次要终点
研究者
Jessica Burris
Principal Investigator
University of Kentucky