An observational study in Lung Cancer, Prostate Cancer and Bladder Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 21 Years to 110 Years. Per ClinicalTrials.gov, last updated 2016-09-12.
Sponsored by National Cancer Institute (NCI) · Observational
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:
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.
7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's enrollment of 30 is below the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.
Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults aged 21 or older who have cancer or are cancer survivors. The cancer can be at any site and any stage.
Patients with any prior confirmed cancer diagnosis being treated or followed at the Center for Cancer Research, Bethesda, Maryland, will be eligible.
3.1.1 Cancer patients with any disease site, stage, and extent of prior therapy will be eligible.
3.1.2 Patients age 21 years old and over will be eligible. The items are intended for use with an adult population, so we need to test with representatives of that population.
3.1.3 Additional eligibility criteria:
3.1.4 Participants must be able to understand and be willing to sign a written informed consent
document. All participants will be asked to provide explicit consent.
3.1.5 Participants are eligible whether they have never used tobacco products of any type, used any type of tobacco previously, or are current tobacco users of any type. (Participant recruitment will be designed to enroll a variety of patients with respect to tobacco use.)
EXCLUSION CRITERIA:
None. (Patients may have already begun protocol treatment.)
INCLUSION OF WOMEN AND MINORITIES:
Both men and women of all races and ethnic groups are eligible for participation in testing of the items. In fact, to the extent possible, we will try to include diversity of demographic characteristics (age, race, gender, education level).
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
Saturation is defined as satisfactory measurement of performance without need of further review.
Time frame: Last subject interviewed, an average of 5 months
Number of Smokers at the Time of the Interview
Current, former, and cigar smokers at the time the interview (e.g. Cancer Patient Tobacco Use Questionnaire (C-TUQ)) was initiated.
Time frame: Day 1 of interview
Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis
Current and former smokers who were smoking at the time of their cancer diagnosis.
Time frame: Day 1 of interview
Time From Cancer Diagnosis to the Date of the Interview
Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ).
Time frame: up to 24 years
| Milestone | Tobacco Use in Cancer Patients and Survivors |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
| Milestone | Tobacco Use in Cancer Patients and Survivors |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
| Milestone | Tobacco Use in Cancer Patients and Survivors |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
| Milestone | Tobacco Use in Cancer Patients and Survivors |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
| Milestone | Tobacco Use in Cancer Patients and Survivors |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
| Milestone | Tobacco Use in Cancer Patients and Survivors |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
Saturation is defined as satisfactory measurement of performance without need of further review.
| participants | All Participants |
|---|---|
| Number of Participants to Achieve Saturation in an English-language Paper Questionnaire | 30 |
Current, former, and cigar smokers at the time the interview (e.g. Cancer Patient Tobacco Use Questionnaire (C-TUQ)) was initiated.
| participants | All Participants |
|---|---|
| Current Smoker | 6 |
| Former Smoker (quit 4-54 years ago) | 23 |
| Cigar Smoker (never smoked cigarettes) | 1 |
Current and former smokers who were smoking at the time of their cancer diagnosis.
| participants | All Participants |
|---|---|
| Current Smoker | 6 |
| Former Smoker | 6 |
Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ).
| years | All Participants |
|---|---|
| Time From Cancer Diagnosis to the Date of the Interview | 3 (1 to 24) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tobacco Use in Cancer Patients and Survivors | — | 0/30 (0%) | 0/30 (0%) |
| Age, Customized(participants) | All Participants |
|---|---|
| Age 20-29 | 1 |
| Age 30-39 | 0 |
| Age 40-49 | 1 |
| Age 50-59 | 13 |
| Age 60-69 | 8 |
| Age 70-79 | 7 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 10 |
| Male | 20 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 29 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(participants) | All Participants |
|---|---|
| White | 25 |
| Black | 4 |
| Asian/PI (Pacific Islander) | 1 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 30 |
| Education (highest level completed)(participants) | All Participants |
|---|---|
| High School/GED | 7 |
| Some college | 11 |
| College degree | 4 |
| Postgraduate degree | 8 |
| Cigarette smoking status(participants) | All Participants |
|---|---|
| Former (quit at least 1yr prior to diagnosis) | 17 |
| Former at enrollment;current at diagnosis | 6 |
| Current | 6 |
| Never (current cigar smoker) | 1 |
| Diagnosis(participants) | All Participants |
|---|---|
| Prostate cancer | 9 |
| Bladder cancer | 3 |
| Lung cancer | 8 |
| Pancreatic cancer | 1 |
| Testicular cancer | 1 |
| Thyroid cancer | 1 |
| Pleural mesothelioma | 3 |
| Thymus cancer | 4 |
1 further baseline measures are reported on the registry.
Plan to share: No
The record gives a start of Sep 2014, a primary completion of Aug 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2016, 11 months after primary completion.
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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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