Cognitive Testing of Tobacco Use Measurement Items for Administration With Cancer Patients and Survivors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants to Achieve Saturation in an English-language Paper Questionnaire [Last subject interviewed, an average of 5 months]
Saturation is defined as satisfactory measurement of performance without need of further review.
- Number of Smokers at the Time of the Interview [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.
- Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis [Day 1 of interview]
Current and former smokers who were smoking at the time of their cancer diagnosis.
- Time From Cancer Diagnosis to the Date of the Interview [up to 24 years]
Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ).
Eligibility Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Stephanie R. Land, Ph.D., National Cancer Institute (NCI)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 140189
- 14-C-0189
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Thirty-five subjects were recruited for this trial but three were unavailable due to time constraints, one was hesitant to participate and one refused to participate. As a result, only 30 subjects were enrolled in the trial. Five participants were assessed for each of the 6 different questionnaires to total 30 participants. |
| Arm/Group Title | Tobacco Use in Cancer Patients and Survivors |
|---|---|
| Arm/Group Description | Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer. Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products. Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting. |
| Period Title: Questionnaire 1 Version 1 | |
| STARTED | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
| Period Title: Questionnaire 1 Version 1 | |
| STARTED | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
| Period Title: Questionnaire 1 Version 1 | |
| STARTED | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
| Period Title: Questionnaire 1 Version 1 | |
| STARTED | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
| Period Title: Questionnaire 1 Version 1 | |
| STARTED | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
| Period Title: Questionnaire 1 Version 1 | |
| STARTED | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer. Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products |
| Overall Participants | 30 |
| Age, Customized (participants) [Number] | |
| Age 20-29 |
1
3.3%
|
| Age 30-39 |
0
0%
|
| Age 40-49 |
1
3.3%
|
| Age 50-59 |
13
43.3%
|
| Age 60-69 |
8
26.7%
|
| Age 70-79 |
7
23.3%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
10
33.3%
|
| Male |
20
66.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
1
3.3%
|
| Not Hispanic or Latino |
29
96.7%
|
| Unknown or Not Reported |
0
0%
|
| Race/Ethnicity, Customized (participants) [Number] | |
| White |
25
83.3%
|
| Black |
4
13.3%
|
| Asian/PI (Pacific Islander) |
1
3.3%
|
| Region of Enrollment (participants) [Number] | |
| United States |
30
100%
|
| Education (highest level completed) (participants) [Number] | |
| High School/GED |
7
23.3%
|
| Some college |
11
36.7%
|
| College degree |
4
13.3%
|
| Postgraduate degree |
8
26.7%
|
| Cigarette smoking status (participants) [Number] | |
| Former (quit at least 1yr prior to diagnosis) |
17
56.7%
|
| Former at enrollment;current at diagnosis |
6
20%
|
| Current |
6
20%
|
| Never (current cigar smoker) |
1
3.3%
|
| Diagnosis (participants) [Number] | |
| Prostate cancer |
9
30%
|
| Bladder cancer |
3
10%
|
| Lung cancer |
8
26.7%
|
| Pancreatic cancer |
1
3.3%
|
| Testicular cancer |
1
3.3%
|
| Thyroid cancer |
1
3.3%
|
| Pleural mesothelioma |
3
10%
|
| Thymus cancer |
4
13.3%
|
| Type of Trials Participants Were Enrolled (participants) [Number] | |
| Tumor-directed therapy clinical trial |
21
70%
|
| Observational study |
6
20%
|
| Patients being screened for trial eligibility |
3
10%
|
Outcome Measures
| Title | Number of Participants to Achieve Saturation in an English-language Paper Questionnaire |
|---|---|
| Description | Saturation is defined as satisfactory measurement of performance without need of further review. |
| Time Frame | Last subject interviewed, an average of 5 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | People who have cancer and who have survived cancer Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products. |
| Measure Participants | 30 |
| Number [participants] |
30
100%
|
| Title | Number of Smokers at the Time of the Interview |
|---|---|
| Description | Current, former, and cigar smokers at the time the interview (e.g. Cancer Patient Tobacco Use Questionnaire (C-TUQ)) was initiated. |
| Time Frame | Day 1 of interview |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer. Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products. Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting. |
| Measure Participants | 30 |
| Current Smoker |
6
20%
|
| Former Smoker (quit 4-54 years ago) |
23
76.7%
|
| Cigar Smoker (never smoked cigarettes) |
1
3.3%
|
| Title | Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis |
|---|---|
| Description | Current and former smokers who were smoking at the time of their cancer diagnosis. |
| Time Frame | Day 1 of interview |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer. Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products. Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting. |
| Measure Participants | 30 |
| Current Smoker |
6
20%
|
| Former Smoker |
6
20%
|
| Title | Time From Cancer Diagnosis to the Date of the Interview |
|---|---|
| Description | Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ). |
| Time Frame | up to 24 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer. Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products. Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting. |
| Measure Participants | 30 |
| Median (Full Range) [years] |
3
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Tobacco Use in Cancer Patients and Survivors | |
| Arm/Group Description | People who have cancer and who have survived cancer Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products. | |
All Cause Mortality |
||
| Tobacco Use in Cancer Patients and Survivors | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Tobacco Use in Cancer Patients and Survivors | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Tobacco Use in Cancer Patients and Survivors | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Stephanie Land |
|---|---|
| Organization | National Cancer Institute (NCI) |
| Phone | 240-276-6946 |
| stephanie.land@nih.gov |
- 140189
- 14-C-0189