Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Prostatic Neoplasms

Lung Neoplasms

Urinary Bladder Neoplasms

Thymoma

Thymus Neoplasms

Thoracic Neoplasms

Lymphatic Diseases

Cognitive testing (e.g. participant interview) of tobacco use in patients (pts) who have cancer and who have survived cancer.

People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.

Participant interview

Stephanie R. Land, Ph.D.

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.

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.

Objectives:

To evaluate and refine proposed questionnaire items that assess tobacco use.

Eligibility:

Cancer patients with any disease site, stage, and extent of prior therapy and age greater than or equal to 21 years.

Design:

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.

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

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

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

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

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

National Cancer Institute (NCI)

Principal Investigator

People who have cancer and who have survived cancer

Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.

Tobacco Use in Cancer Patients and Survivors

Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.

Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products

All Participants

Age 20-29

Age 30-39

Age 40-49

Age 50-59

Age 60-69

Age 70-79

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black

Asian/PI (Pacific Islander)

Race/Ethnicity, Customized

United States

Region of Enrollment

High School/GED

Some college

College degree

Postgraduate degree

Education (highest level completed)

Former (quit at least 1yr prior to diagnosis)

Former at enrollment;current at diagnosis

Current

Never (current cigar smoker)

Cigarette smoking status

Prostate cancer

Bladder cancer

Lung cancer

Pancreatic cancer

Testicular cancer

Thyroid cancer

Pleural mesothelioma

Thymus cancer

Diagnosis

Tumor-directed therapy clinical trial

Observational study

Patients being screened for trial eligibility

Type of Trials Participants Were Enrolled

Dr. Stephanie Land

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

Current Smoker

Former Smoker (quit 4-54 years ago)

Cigar Smoker (never smoked cigarettes)

Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.

Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.

Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting.

Number of Smokers at the Time of the Interview

Former Smoker

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cognitive Testing of Tobacco Use Measurement Items for Administration With Cancer Patients and Survivors	NCT02233842	Lung Cancer Prostate Cancer Bladder Cancer Thymic Cancer	Participant int...	21 Years - 110 Years	National Institutes of Health Clinical Center (CC)
Cognitive Testing of Tobacco Use Measurement Items for Administration With Cancer Patients and Survivors	NCT02233842	Lung Cancer Prostate Cancer Bladder Cancer Thymic Cancer	Participant int...	21 Years - 110 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for qualitative data