Clinical trial NCT02233842: Cognitive Testing of Tobacco Use Measurement Items for Administration With Cancer Patients and Survivors
Official title: Cognitive Testing of Tobacco Use Measurement Items for Administration With Cancer Patients and Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Prostate Cancer
Bladder Cancer
Thymic Cancer
Keywords: Qualitative Data
Questionnaire
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2014-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 21 or older who have cancer or are cancer survivors. The cancer can be at any site and any stage.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: * INCLUSION CRITERIA:

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:

* Individuals must be able to understand and willing to answer items about their own tobacco use.
* Individuals must be able to read and speak English. For purposes of this study, we will limit participation to adults who can self-consent and self-report in English (vs. only being able to respond with the aid of a translator). The materials have been developed in English; this is intended to be cognitive testing of an English language questionnaire. (If a Spanish translation of the items will be developed in the future, a separate cognitive testing effort will be needed to ensure cultural equivalence of the items.)

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).

Primary outcomes:
measure: Number of Participants to Achieve Saturation in an English-language Paper Questionnaire
timeFrame: Last subject interviewed, an average of 5 months
measure: Number of Smokers at the Time of the Interview
timeFrame: Day 1 of interview
measure: Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis
timeFrame: Day 1 of interview
measure: Time From Cancer Diagnosis to the Date of the Interview
timeFrame: up to 24 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Stephanie R. Land, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Land SR, Warren GW, Crafts JL, Hatsukami DK, Ostroff JS, Willis GB, Chollette VY, Mitchell SA, Folz JN, Gulley JL, Szabo E, Brandon TH, Duffy SA, Toll BA. Cognitive testing of tobacco use items for administration to patients with cancer and cancer survivors in clinical research. Cancer. 2016 Jun 1;122(11):1728-34. doi: 10.1002/cncr.29964. Epub 2016 Mar 28.
citation: Land SR, Toll BA, Moinpour CM, Mitchell SA, Ostroff JS, Hatsukami DK, Duffy SA, Gritz ER, Rigotti NA, Brandon TH, Prindiville SA, Sarna LP, Schnoll RA, Herbst RS, Cinciripini PM, Leischow SJ, Dresler CM, Fiore MC, Warren GW. Research Priorities, Measures, and Recommendations for Assessment of Tobacco Use in Clinical Cancer Research. Clin Cancer Res. 2016 Apr 15;22(8):1907-13. doi: 10.1158/1078-0432.CCR-16-0104. Epub 2016 Feb 17.