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临床试验/NCT02233842
NCT02233842已完成不适用

Cognitive Testing of Tobacco Use Measurement Items for Administration With Cancer Patients and Survivors

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年9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
30
试验地点
1
主要终点
Number of Smokers at the Time of the Interview

研究概览

简要总结

Background:

  • People who have cancer have more medical problems if they smoke. Some studies show that smoking even makes cancer treatment less effective. Researchers want to teach people about how tobacco use affects people after a cancer diagnosis. They want to come up with questions for people who have cancer and who have survived cancer. The questions will be about using cigarettes and other tobacco products and about second-hand smoke.

The questions will be used to understand how using tobacco affects people with cancer before, during, and after treatment. This will help doctors plan how to treat people with cancer and create programs to help people quit smoking in the future.

Objective:

  • To evaluate and refine questions that assess tobacco use.

Eligibility:

  • Adults age 21 or older who have cancer or are cancer survivors. The cancer can be at any site and any stage.

Design:

  • This study will take about 1 hour.
  • Participants will meet one-on-one with an interviewer. They will fill out a questionnaire and talk about the questions. Participants will explain how easy or hard it was to answer the questions and how they decided on their answers.
  • All participants will be asked the same or very similar questions. Specific questions will be based on the participants own experiences with tobacco products.
  • There will be no follow-up activities.

详细描述

Background:

Studies comparing cancer patients who smoke cigarettes at the time of diagnosis to former or never smokers have demonstrated increased difficulty with surgical wound healing and more treatment morbidity; reduced radiation and chemotherapy efficacy; reduced time to recurrence, progression, and second primary cancers; and increased mortality. Some studies have found that smoking interacts with cancer therapy efficacy.

Cigarette smoking is prevalent among patients with lung and head and neck cancers, with rates as high as 40% to 60% as of the time of diagnosis. The rate of smoking among cancer survivors has been estimated as 21% for lung cancer survivors and 39% for survivors of other cancers.(11)

Only 22% of NCI-funded phase III trials conducted by Cooperative Groups record patients cigarette smoking status among patients at the time of enrollment, and 4% record cigarette smoking status during follow-up.

We need to examine the impact of tobacco use on a wider range of therapeutic regimens and settings, with more detailed longitudinal tobacco use assessment. Research in this area is impeded by inadequate assessment of tobacco use after cancer diagnosis and a lack of valid, harmonized measures that are tailored to the trajectory of cancer diagnosis, treatment and survivorship.(15) The NCI-AACR Cancer Patient Tobacco Use Assessment Task Force formed in 2013 to develop recommendations for assessing tobacco use by cancer patients. The long- range goal of the Task Force is to advance the state of knowledge about the effect of tobacco use after a cancer diagnosis, to inform cancer treatment decision-making and to guide patients and providers regarding the timing and clinical significance of tobacco cessation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
21 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Smokers at the Time of the Interview

时间窗: Day 1 of interview

Current, former, and cigar smokers at the time the interview (e.g. Cancer Patient Tobacco Use Questionnaire (C-TUQ)) was initiated.

Time From Cancer Diagnosis to the Date of the Interview

时间窗: up to 24 years

Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ).

Number of Participants to Achieve Saturation in an English-language Paper Questionnaire

时间窗: Last subject interviewed, an average of 5 months

Saturation is defined as satisfactory measurement of performance without need of further review.

Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis

时间窗: Day 1 of interview

Current and former smokers who were smoking at the time of their cancer diagnosis.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Principal Investigator
主要研究者

Stephanie Land, Ph.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

研究点 (1)

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