Clinical trial · Observational
Cognitive Testing of Tobacco Use Measurement Items for Administration With Cancer Patients and Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Thymic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Participant interview | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Tobacco Use in Cancer Pts & Survivors
- description
- Cognitive testing (e.g. participant interview) of tobacco use in patients (pts) who have cancer and who have survived cancer.
- interventionNames
- Behavioral: Participant interview
Primary outcomes (4)
- measure
- Number of Participants to Achieve Saturation in an English-language Paper Questionnaire
- timeFrame
- Last subject interviewed, an average of 5 months
- description
- Saturation is defined as satisfactory measurement of performance without need of further review.
- measure
- Number of Smokers at the Time of the Interview
- timeFrame
- Day 1 of interview
- description
- Current, former, and cigar smokers at the time the interview (e.g. Cancer Patient Tobacco Use Questionnaire (C-TUQ)) was initiated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 110 Years
Show eligibility criteria text
* 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).
References
Publications (2)
- RESULTLand 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
- RESULTLand 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