M-D-Y
Initials of RA conducting screen
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Date of initial note
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Today M-D-Y
Thank you for your interest in our research study. The following screening survey is set up for your safety and to determine if you may qualify for one of our current studies. These questions will take between 5-10 minutes. If we determine that you may qualify, a study staff member will provide you with more detailed information about the study and will ask you additional questions to determine if you are eligible to complete the screening session. You may also call our lab at 919-907-9955 if you prefer to talk to a staff member directly.
Answering these questions is voluntary. You are under no obligation to answer them, and not answering them will have no effect on your health care at Duke. Not answering the questions, however, means that you will not be eligible to participate in this research study. Your responses to these questions will be kept on a secure password-protected server, and only staff members associated with this study have access to the data. While we do our best to protect your information, there is always a risk of breach of confidentiality. If at any time during this prescreening you would like to stop and not participate you may simply close your browser.
Hi, this is [NAME] calling from Triangle Smoking Studies. I'm calling about the online screener you completed about participating in research about smoking and pain. Is this a good time to ask you a few more questions to determine if you might be eligible to participate?
Answering these questions is voluntary. You are under no obligation to answer them, and not answering them will have no effect on your health care at Duke. Not answering the questions, however, means that you will not be eligible to participate in this research study.
Here is some information about the confidentiality of the information I collect today. Regardless of whether you are eligible nor not, we will keep your contact information (name, email address, phone number, etc.) as well as basic demographic and study eligibility information. This data will be stored on a secure, password-protected server. If you do qualify for the study and decide to participate, we will ask you to sign a consent form at your first appointment. The personal information you give me today will become part of your research record and will be reviewed by Dr. Sweitzer and the research staff. While we do our best to protect your information, there is always a risk of breach of confidentiality. If at any time during this prescreening you would like to stop and not participate or if you have any questions, just let me know.
Would you like to continue now with the screening questions?
Below is a description of our current study. Please take a minute to read the description.
VLNC Pain: The purpose of this study is to evaluate the effects of switching to very low nicotine content (VLNC) cigarettes versus normal nicotine content (NNC) cigarettes on experiences with craving, withdrawal, and pain among individuals with chronic back pain who smoke cigarettes daily. This study will help us to learn more about the role of nicotine in the relationship between smoking and pain, and we hope this will lead to improved treatments for smokers with pain who want to quit smoking.
This is not a treatment study. We are recruiting smokers with back pain between the ages of 21 and 70 who are not currently trying to quit smoking. This study requires a screening visit, followed by 7 in-person visits. You will be asked to stop smoking for 24 hours prior to 2 of these visits. We will ask you smoke only study cigarettes that we provide instead of your usual brand for 4 weeks of the study. You will also be asked to install software on your smartphone and respond to questions about your smoking, craving, mood, and pain symptoms multiple times per day during 3 weeks of the study. You can earn up to $1235 for completing all aspects of the study.
Would you like to continue with the screening questions?
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Yes, I would like to continue with the screening.
No, I am not interested at this time.
Best phone number to reach you
Best time to reach you during business hours?
Sex assigned at birth
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Female Male Intersex/Ambiguous
Which of the following describes how you think of yourself?
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Female or primarily feminine Male or primarily masculine Both male and female Neither male nor female In another way
How many DAYS in the past 30 have you smoked cigarettes?
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How many cigarettes do you smoke each day?
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one number please
Has your cigarette smoking changed in the past 6 months?
Yes No
did they quit for a period of time, increased/decreased CPD
If yes, how? (please describe)
CODE THE NEXT QUESTION BASED ON THE PARTICIPANT'S PREVIOUS RESPONSES
Has the subject smoked at least 10 cigarettes per day over the past 6 months?
Yes No
Do you roll your own cigarettes?
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Yes No
How many days in past 30 did you roll your own cigarettes?
What brand of cigarettes do you prefer to smoke?
How many DAYS in the past 30 have you used other tobacco products (i.e. cigars, cigarillos like Black and Milds, e-cigarettes like JUUL, etc)?
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What other tobacco products do you use? (i.e. cigars, cigarillos, e-cigarettes)?
Are you planning to quit smoking in the next one to two months?
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Yes No
In the past 30 days, have you attempted to quit smoking?
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Yes No
If "Yes": Did you quit smoking completely for 3 days or more?
Yes No
Do you currently suffer from back pain on a regular basis?
Yes No
Over the past 3 months, on a scale of 0-10, what was your AVERAGE level of pain? Use a scale of 0-10, where 0 is 'no pain' and 10 is 'pain as bad as it could be'.
0 1 2 3 4 5 6 7 8 9 10
Over the past 3 months, on a scale of 0-10, what was your WORST level of pain? Use a scale of 0-10, where 0 is 'no pain' and 10 is 'pain as bad as it could be'.
0 1 2 3 4 5 6 7 8 9 10
Are you currently taking any opioid pain medications (e.g., percoset, Vicodin, oxycontin, Tylenol 3, etc.)?
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Yes No
Have you ever seen any of the following medical providers for back pain? (check all that apply):
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When was the last time you saw a medical provider about back pain?
Was this provider seen at Duke?
Yes No
Now I would like to ask you some additional questions about your mental health and medical history. I would like to remind you that answering these questions is voluntary. You are under no obligation to answer them, and not answering them will have no effect on your health care at Duke.
Have you ever been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder?
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Yes No
How frequently do you drink alcohol?
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daily_or_almost_daily 3-5_times_per_week 1-2_times_per_week at_least_monthly_but_less_than_weekly less_than_once_per_month rarely_or_never
In the past month, how frequently did you use marijuana?
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daily_or_almost_daily 3-5_times_per_week 1-2_times_per_week 1-2_times_per_month rarely_or_never
Are you willing to go without using marijuana for the month prior to the screen and while you are enrolled in the study?
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Yes No
Have you taken illicit drugs on 12 or more days out of the past 6 months?
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Yes No
Have you experienced any problems from drugs or alcohol or had any formal treatment for drugs or alcohol in the past year?
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Yes No
Do any of these medical or health issues apply to you?
Current major medical problem such as heart disease, cancer, or emphysema Heart attack in the past 90 days Use of Theophylline for asthma Currently pregnant, breast feeding, or trying to become pregnant Currently using nicotine replacement therapies or other treatments to quit smoking
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Yes, at least one of these applies to me
No, none of these apply to me
Unsure of whether any of these apply to me
Have you had spinal surgery in the past year?
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Yes
No
Are you planning to have surgery in the next 3 months?
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Yes
No
Do you have an ongoing disability claim?
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Yes No
Do you have a smartphone with a data plan?
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Yes
No
Do you have any routine times during which you will not be able to participate in a study?
How did you hear about this study?
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Craigslist DukeList Flyer Newspaper Radio Friend/Referral Facebook Instagram Reddit MyChart Researchmatch.org Other
If you do not qualify for this study, would you like to be contacted for future studies?
Yes
No
Is the subject web screen eligible?
Eligible = 1
Ineligible = 2
Pending = 9
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CHECK UNSURE ON MEDICAL QUESTIONS
CHECK TOTAL OTHER TOBACCO USE
Has the phone screen been completed?
Yes
No
Is the subject eligible to enroll?
Yes
No
Ask the Covid Screener Questions Have you had a positive Covid-19 test in the past 30 days?
Covid Screener
Reasons Not Eligible - Calculated
Pass=1
Fail=2
Not yet assessed/Pending =99 View equation
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Yes
No