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临床试验/NCT00345891
NCT00345891已完成不适用

Quite Smoking Program for Lung Cancer Patients' Families

Duke University8 个研究点 分布在 1 个国家目标入组 496 人开始时间: 2004年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
496
试验地点
8
主要终点
7-day point-prevalence abstinence at 2 weeks and 6 month follow-up

研究概览

简要总结

The purpose of this study is to evaluate the impact of delivering a coping-focused intervention as an adjunct to a self-help program to promote smoking cessation among relatives of lung cancer patients.

详细描述

Despite the fact that lung cancer is attributed almost entirely to cigarette smoking and smoking cessation substantially decreases the risk for lung cancer, many smokers are not significantly motivated to quit smoking. A loved one's diagnosis of terminal lung cancer diagnosis presents a time when relatives who smoke are in need of and may be especially receptive to smoking cessation interventions.

The overarching aim of the study is to evaluate in a randomized trial the impact of delivering a coping-focused intervention as an adjunct to a state-of-the-science self-help program to promote smoking cessation among relatives of lung cancer patients. The specific aims are as follows:

  1. To evaluate the impact of a coping-focused self-help intervention on relatives' rates of abstinence from cigarettes at 2 weeks, 6- and 12-months post-treatment follow-ups.
  2. To evaluate whether any observed intervention effect on abstinence rates is mediated by improvements in relative's cognitive appraisals specifically self-efficacy, and perceived control over health outcomes, adaptive coping responses, and decreases in stress and depression
  3. To evaluate the cost-effectiveness of the standard self-help and coping-focused interventions.

Patient diagnosed with lung cancer will be contacted and asked to enumerate their relatives (i.e., immediate family, extended family, spouses, and anyone perceived as family) and asked the smoking status of each of these relatives. Patients will then be asked for permission to send their relatives who smoke a letter that describes the study and provides a telephone number to call to decline participation. Patients who are current smokers may receive materials to help them stop smoking.

The relatives who do not call to decline participation will be contacted by the survey company to ask them to participate in a telephone survey. If eligible and willing, verbal consent will be obtained from relatives who smoke to complete the 20-30 minute baseline survey. During the telephone contact, relatives will have the opportunity to decline to complete the survey and to be further involved in the research study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria-Patients:
  • Diagnosis of lung cancer
  • Ages 18 or older
  • Able to consent
  • Inclusion Criteria-Family Members:
  • Patient has given consent to contact the family member
  • Ages 18 or older
  • Speaks and reads English
  • Cognitively able to give consent to participate
  • Has access to a telephone
  • Smoked at least 100 cigarettes in his/her life
  • Smoked any cigarettes in the prior 7 days at screening

排除标准

  • Patients or family members who do not meet inclusion criteria

结局指标

主要结局

7-day point-prevalence abstinence at 2 weeks and 6 month follow-up

次要结局

  • 7-day point-prevalence abstinence at the 12-month follow-up and prolonged abstinence

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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