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

August 1, 2016 updated by: Stephanie Land, Ph.D., National Cancer Institute (NCI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Last subject interviewed, an average of 5 months
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.
Day 1 of interview
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.
Day 1 of interview
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).
up to 24 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Stephanie R. Land, Ph.D., National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 6, 2014

First Submitted That Met QC Criteria

September 6, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Estimate)

September 12, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140189
  • 14-C-0189

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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