The StarNet Case Control Study and the Role of the Study Coordinator

1. The StarNet Case Control Study and the Role of the Study Coordinator Sofia Husain and Sarah Ruuska, MPH Study Coordinators UW Center for Clinical Genomics

2. Overview • Research question • Study design • Study protocol • Role of study coordinator • Progress to date

3. Research Question Do genetic and environmental factors influence whether a person becomes a persistent smoker or not?

4. Study Design • Case-control design • Cases: current daily smokers • Controls: current non-smokers but who have smoked between 11 and 100 cigarettes in their lifetime • Compare cases and controls to see if there are any differences in environmental exposures or genetics between the two groups

5. General Eligibility Criteria • Participants: • Men and women, ages 25-54 • All races/ethnicities • Live in greater Seattle area • English-speaking • Plan to recruit at least 400 subjects by August 2009

6. Data Collection: Questionnaire • Collect information on: • smoking or non-smoking behaviors • environmental exposures that may influence the decision to start or stop smoking such as family and peer attitudes, public policies, health messages, etc.

7. Data Collection: Questionnaire • Question examples: • How old were you when you first tried a cigarette, even a single puff? • During your experimental smoking phase, did you think that smoking was “cool”? • While you were growing up, how many of your parents/guardians smoked at all? • When you were in school, were you taught about the dangers of smoking (for example, lung cancer, heart disease, fire hazards)?

8. Data Collection: Blood Draw • Blood sample for DNA • 2 teaspoons of blood

9. How do we conduct the study? • How do we find the subjects we need? • How do we determine if these subjects meet the study definition of case/control? • How will we get subjects to participate? • How will we gather the data we need? • How do we make sure subjects understand what they are agreeing to do for the study?

10. How do we find subjects? • Advertise via study fliers posted in Seattle area: coffee shops, community centers, churches, etc. • Advertise in local newspapers: The Seattle Weekly, The Stranger, neighborhood papers • Advertise on the internet: UW Research Studies website, Craigslist

11. Study Flier

12. How do we determine if the subjects we find meet the study definitions? • Subjects respond to the study ad by calling the study coordinator to express interest or request more information • Study coordinator gives a short survey over the phone to make sure subjects are within the age range of 25 to 54 years old, determine if their smoking behavior fits either the case or control definition

13. How do we get subjects to participate? • Contribute to scientific knowledge • Help society • Help teach high school students about science • Reimbursement for parking fees • Thank-you gift • $30 Safeway gift card after completing study

14. How will we gather the data we need? • Subjects will come to the UW General Clinical Research Center (GCRC) to: • Fill out the study questionnaire • Blood draw

15. How do we make sure subjects understand what they are agreeing to do for the study? • Be careful to state clearly what is being asked of the subject both verbally and in writing • Give the subject opportunity to ask questions, inform them of their rights as a research subject • Process of informed consent

16. Informed Consent Crucial elements: • Participation in research is voluntary • Ability to withdraw from study at any time without penalty (financial, health insurance, health care, etc.) • Privacy and confidentiality • Clearly state study procedures, what subject will be asked to do, and the time it will take

17. Informed Consent Crucial elements (continued): • State risks • Sensitive questions, slight pain and bruising from blood draw • State benefits • No direct benefit to the subject • Better understanding of factors that contribute to smoking behavior

18. Approval to Conduct Study • Institutional Review Board Review • Reviews all research on human subjects BEFORE study begins to ensure: • No coercion of study subjects • Benefits of research outweigh the risks • No one group is being singled out or studied too much • Consent form and all study materials are understandable

19. Role of a Study Coordinator • Assists with study design and protocol development • Prepares study materials • Helps get approval to conduct the study • Coordinates day-to-day study operations • Interacts with study subjects, schedules appointments • Collects data (questionnaires, interviews, biologic samples)

20. Role of a Study Coordinator • Administrative aspects: • Budget preparation, purchasing, hiring study staff, supervision of interviewers, technicians, etc. • Works directly with the Principal Investigator and other study investigators • Educational background: nursing, public health, health sciences

21. Role of StarNet Study Coordinator: Setting Up the Study • Apply to UW IRB for approval to conduct the study • Develop study documents • Newspaper ad, study flier • Consent form • Subject contact materials (letter, reminder call script, directions to UW, etc.) • Phone screening survey • Written questionnaire • Develop study protocol and logistics (where to post ads, how do we reimburse subjects for parking?)

22. Role of StarNet Study Coordinator: Conducting the Study • Place ads in newspapers • Answer study phone line when subjects respond to study ad, describe the study and give the screening survey • Schedule the study appointment • Mail study packet to study participants to review before their appointment

23. Role of StarNet Study Coordinator: Conducting the Study • Meet subjects for their study appointment at the UW General Clinical Research Center • Go over consent form • Give the questionnaire • Coordinate the blood draw • Available to answer questions throughout study visit • Give out thank-you gift • After the visit: • Transport blood samples to the lab • Check samples in for processing

24. Results so Far

25. Challenges • Getting a good response to the newspaper ads & fliers • Being able get in touch with everyone who calls (13% unable to get in touch with) • Finding people who fit the case/control definitions (23% eligible) • Getting people to show up for their study appointment (17% no-show rate)