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

NCT02233842 | Completed Results

• 2 other identifiers: 14018914-C-0189
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Prostate Cancer; Bladder Cancer; Thymic Cancer

Keywords

Qualitative Data; Questionnaire

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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).

  up to 24 years

Study Arms (1)

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

Interventions

Participant interview BEHAVIORAL

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 Pts & Survivors

Eligibility Criteria

• Age: 21 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with any prior confirmed cancer diagnosis being treated or followed at the Center for Cancer Research, Bethesda, Maryland, will be eligible.
• Cancer patients with any disease site, stage, and extent of prior therapy will be eligible.
• 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.
• 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.)
• 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.
• 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.)

You may not qualify if:

• None. (Patients may have already begun protocol treatment.)
• 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).

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• 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.

  PMID: 27019325 RESULT

• 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.

  PMID: 26888828 RESULT

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Lung Neoplasms; Prostatic Neoplasms; Urinary Bladder Neoplasms; Thymus Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr. Stephanie Land
• Organization: National Cancer Institute (NCI)

stephanie.land@nih.gov

240-276-6946

Study Officials

• Stephanie R. Land, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2014
• First Posted: September 9, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 12, 2016
• Results First Posted: July 27, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)