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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02233842
First Posted: September 9, 2014
Last Update Posted: September 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stephanie Land, Ph.D., National Institutes of Health Clinical Center (CC)
Results First Submitted: June 16, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Conditions: Lung Cancer
Prostate Cancer
Bladder Cancer
Thymic Cancer
Intervention: Behavioral: Participant interview

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Tobacco Use in Cancer Patients and Survivors

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.


Participant Flow for 6 periods

Period 1:   Questionnaire 1 Version 1
    Tobacco Use in Cancer Patients and Survivors
STARTED   5 
COMPLETED   5 
NOT COMPLETED   0 

Period 2:   Questionnaire 1 Version 2
    Tobacco Use in Cancer Patients and Survivors
STARTED   5 
COMPLETED   5 
NOT COMPLETED   0 

Period 3:   Questionnaire 2 Version 1
    Tobacco Use in Cancer Patients and Survivors
STARTED   5 
COMPLETED   5 
NOT COMPLETED   0 

Period 4:   Questionnaire 2 Version 2
    Tobacco Use in Cancer Patients and Survivors
STARTED   5 
COMPLETED   5 
NOT COMPLETED   0 

Period 5:   Questionnaire 3 Version 1
    Tobacco Use in Cancer Patients and Survivors
STARTED   5 
COMPLETED   5 
NOT COMPLETED   0 

Period 6:   Questionnaire 3 Version 2
    Tobacco Use in Cancer Patients and Survivors
STARTED   5 
COMPLETED   5 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Participants

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


Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age, Customized 
[Units: Participants]
 
Age 20-29   1 
Age 30-39   0 
Age 40-49   1 
Age 50-59   13 
Age 60-69   8 
Age 70-79   7 
Gender 
[Units: Participants]
 
Female   10 
Male   20 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   1 
Not Hispanic or Latino   29 
Unknown or Not Reported   0 
Race/Ethnicity, Customized 
[Units: Participants]
 
White   25 
Black   4 
Asian/PI (Pacific Islander)   1 
Region of Enrollment 
[Units: Participants]
 
United States   30 
Education (highest level completed) 
[Units: Participants]
 
High School/GED   7 
Some college   11 
College degree   4 
Postgraduate degree   8 
Cigarette smoking status 
[Units: Participants]
 
Former (quit at least 1yr prior to diagnosis)   17 
Former at enrollment;current at diagnosis   6 
Current   6 
Never (current cigar smoker)   1 
Diagnosis 
[Units: Participants]
 
Prostate cancer   9 
Bladder cancer   3 
Lung cancer   8 
Pancreatic cancer   1 
Testicular cancer   1 
Thyroid cancer   1 
Pleural mesothelioma   3 
Thymus cancer   4 
Type of Trials Participants Were Enrolled 
[Units: Participants]
 
Tumor-directed therapy clinical trial   21 
Observational study   6 
Patients being screened for trial eligibility   3 


  Outcome Measures
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1.  Primary:   Number of Participants to Achieve Saturation in an English-language Paper Questionnaire   [ Time Frame: Last subject interviewed, an average of 5 months ]

2.  Primary:   Number of Smokers at the Time of the Interview   [ Time Frame: Day 1 of interview ]

3.  Primary:   Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis   [ Time Frame: Day 1 of interview ]

4.  Primary:   Time From Cancer Diagnosis to the Date of the Interview   [ Time Frame: up to 24 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: stephanie.land@nih.gov


Publications of Results:

Responsible Party: Stephanie Land, Ph.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02233842     History of Changes
Other Study ID Numbers: 140189
14-C-0189
First Submitted: September 6, 2014
First Posted: September 9, 2014
Results First Submitted: June 16, 2016
Results First Posted: July 27, 2016
Last Update Posted: September 12, 2016