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

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.

- 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).