Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 18
- 主要终点
- Change in urine cotinine level
研究概览
简要总结
RATIONALE: Providing parent/caregivers of children with cancer with education and evidence of secondhand smoke exposure can protect the child from future exposure to tobacco smoke.
PURPOSE: This randomized study will compare education only to education plus cotinine feedback in decreasing secondhand smoke exposure in pediatric patients with cancer that reside with a household smoker.
详细描述
OBJECTIVES:
The primary objective of this study is to determine if providing urine cotinine feedback to caregivers in conjunction with standard education will be more effective than education alone in reducing patient SHS exposure.
The secondary objectives of this study are:
To determine whether urine cotinine feedback in conjunction with education provided to the caregiver is more effective in changing parental smoking behavior compared to education alone.
As an exploratory measure we will collect history and physical exam data to follow patient's clinical complications during the study to determine if patients with a decrease in SHS exposure also have a decrease in clinical complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 2 years and ≤ 12 years at the time of study entry.
- •Currently undergoing treatment for cancer at the time of enrollment, at least 28 days post diagnosis.
- •The child must reside 5 days a week with a household smoker (defined as a person who smokes greater than 10 cigarettes daily).
- •Child must be potty trained.
- •Parent/Legal Guardian ≥ 18 years of age.
- •Parent/Legal Guardian who accompanies the child to the first visit must accompany the child to all other visits. This person does not need to be the household smoker, but must be willing to educate the smoker on results at the visit and take the education handout home to them.
- •Parent/Legal Guardian must have a working phone to complete the week 5 follow-up phone call.
- •Able and willing to sign informed consent/assent.
- •Signed HIPAA compliant research authorization.
排除标准
- •Planned hospitalization within 3 days of any scheduled study visit (due to the urine cotinine measurement representing the previous 48-72 hours of tobacco exposure.
- •Inability to perform the initial cotinine test.
结局指标
主要结局
Change in urine cotinine level
时间窗: 4 weeks after baseline visit
The primary objective of this study is to determine if providing urine cotinine feedback to caregivers in conjunction with standard education will be more effective than education alone in reducing patient SHS exposure.
次要结局
- Change in Self-Reported Smoking Behavior(4 weeks after baseline visit)
- Number of medical complications(4 weeks after baseline visit)