Cognitive Testing of Tobacco Use Measurement Items for Administration With Cancer Patients and Survivors
|ClinicalTrials.gov Identifier: NCT02233842|
Recruitment Status : Completed
First Posted : September 9, 2014
Results First Posted : July 27, 2016
Last Update Posted : September 12, 2016
- 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.
- To evaluate and refine questions that assess tobacco use.
- Adults age 21 or older who have cancer or are cancer survivors. The cancer can be at any site and any stage.
- 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.
|Condition or disease||Intervention/treatment|
|Lung Cancer Prostate Cancer Bladder Cancer Thymic Cancer||Behavioral: Participant interview|
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.
To evaluate and refine proposed questionnaire items that assess tobacco use.
Cancer patients with any disease site, stage, and extent of prior therapy and age greater than or equal to 21 years.
This study will evaluate and refine proposed questionnaire items that assess tobacco use in the cancer patient and survivor population. This study is purely qualitative. No research hypotheses will be tested in this study. There will be no therapy, administration of agent(s), or imaging administered as part of this study. Participants will only be asked to answer questions and then discuss their answers to the questions.
Patients who consent will participate in a session that will last up to one hour. They will complete a questionnaire about tobacco use and answer debriefing questions so that the interviewer can assess question comprehension, ease of answering, and accuracy of response.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Cognitive Testing of Tobacco Use Measurement Items for Administration With Cancer Patients and Survivors|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Tobacco Use in Cancer Pts & Survivors
Cognitive testing (e.g. participant interview) of tobacco use in patients (pts) who have cancer and who have survived cancer.
Behavioral: Participant interview
People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.
- Number of Participants to Achieve Saturation in an English-language Paper Questionnaire [ Time Frame: Last subject interviewed, an average of 5 months ]Saturation is defined as satisfactory measurement of performance without need of further review.
- Number of Smokers at the Time of the Interview [ Time Frame: 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.
- Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis [ Time Frame: Day 1 of interview ]Current and former smokers who were smoking at the time of their cancer diagnosis.
- Time From Cancer Diagnosis to the Date of the Interview [ Time Frame: up to 24 years ]Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233842
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Stephanie R. Land, Ph.D.||National Cancer Institute (NCI)|