Trial Outcomes & Findings for Cognitive Testing of Tobacco Use Measurement Items for Administration With Cancer Patients and Survivors (NCT NCT02233842)

NCT ID: NCT02233842

Last Updated: 2016-09-12

Results Overview

Saturation is defined as satisfactory measurement of performance without need of further review.

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: Last subject interviewed, an average of 5 months
• Results posted on: 2016-09-12

Participant Flow

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.

Participant milestones

Measure	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.
Questionnaire 1 Version 1 STARTED	5
Questionnaire 1 Version 1 COMPLETED	5
Questionnaire 1 Version 1 NOT COMPLETED	0
Questionnaire 1 Version 2 STARTED	5
Questionnaire 1 Version 2 COMPLETED	5
Questionnaire 1 Version 2 NOT COMPLETED	0
Questionnaire 2 Version 1 STARTED	5
Questionnaire 2 Version 1 COMPLETED	5
Questionnaire 2 Version 1 NOT COMPLETED	0
Questionnaire 2 Version 2 STARTED	5
Questionnaire 2 Version 2 COMPLETED	5
Questionnaire 2 Version 2 NOT COMPLETED	0
Questionnaire 3 Version 1 STARTED	5
Questionnaire 3 Version 1 COMPLETED	5
Questionnaire 3 Version 1 NOT COMPLETED	0
Questionnaire 3 Version 2 STARTED	5
Questionnaire 3 Version 2 COMPLETED	5
Questionnaire 3 Version 2 NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	All Participants n=30 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
Age, Customized Age 20-29	1 participants n=93 Participants
Age, Customized Age 30-39	0 participants n=93 Participants
Age, Customized Age 40-49	1 participants n=93 Participants
Age, Customized Age 50-59	13 participants n=93 Participants
Age, Customized Age 60-69	8 participants n=93 Participants
Age, Customized Age 70-79	7 participants n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	20 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race/Ethnicity, Customized White	25 participants n=93 Participants
Race/Ethnicity, Customized Black	4 participants n=93 Participants
Race/Ethnicity, Customized Asian/PI (Pacific Islander)	1 participants n=93 Participants
Region of Enrollment United States	30 participants n=93 Participants
Education (highest level completed) High School/GED	7 participants n=93 Participants
Education (highest level completed) Some college	11 participants n=93 Participants
Education (highest level completed) College degree	4 participants n=93 Participants
Education (highest level completed) Postgraduate degree	8 participants n=93 Participants
Cigarette smoking status Former (quit at least 1yr prior to diagnosis)	17 participants n=93 Participants
Cigarette smoking status Former at enrollment;current at diagnosis	6 participants n=93 Participants
Cigarette smoking status Current	6 participants n=93 Participants
Cigarette smoking status Never (current cigar smoker)	1 participants n=93 Participants
Diagnosis Prostate cancer	9 participants n=93 Participants
Diagnosis Bladder cancer	3 participants n=93 Participants
Diagnosis Lung cancer	8 participants n=93 Participants
Diagnosis Pancreatic cancer	1 participants n=93 Participants
Diagnosis Testicular cancer	1 participants n=93 Participants
Diagnosis Thyroid cancer	1 participants n=93 Participants
Diagnosis Pleural mesothelioma	3 participants n=93 Participants
Diagnosis Thymus cancer	4 participants n=93 Participants
Type of Trials Participants Were Enrolled Tumor-directed therapy clinical trial	21 participants n=93 Participants
Type of Trials Participants Were Enrolled Observational study	6 participants n=93 Participants
Type of Trials Participants Were Enrolled Patients being screened for trial eligibility	3 participants n=93 Participants

PRIMARY outcome

Timeframe: Last subject interviewed, an average of 5 months

Saturation is defined as satisfactory measurement of performance without need of further review.

Outcome measures

Measure	All Participants n=30 Participants 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.
Number of Participants to Achieve Saturation in an English-language Paper Questionnaire	30 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	All Participants n=30 Participants 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.
Number of Smokers at the Time of the Interview Current Smoker	6 participants
Number of Smokers at the Time of the Interview Former Smoker (quit 4-54 years ago)	23 participants
Number of Smokers at the Time of the Interview Cigar Smoker (never smoked cigarettes)	1 participants

PRIMARY outcome

Timeframe: Day 1 of interview

Current and former smokers who were smoking at the time of their cancer diagnosis.

Outcome measures

Measure	All Participants n=30 Participants 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.
Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis Current Smoker	6 participants
Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis Former Smoker	6 participants

PRIMARY outcome

Timeframe: up to 24 years

Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ).

Outcome measures

Measure	All Participants n=30 Participants 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.
Time From Cancer Diagnosis to the Date of the Interview	3 years Interval 1.0 to 24.0

Adverse Events

Tobacco Use in Cancer Patients and Survivors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stephanie Land

National Cancer Institute (NCI)

Phone: 240-276-6946

Email: stephanie.land@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place