Microsoft word - may03-1-03 phone contact script.doc

“Randomized Phase IIb Trial of Atorvastatin, Raftilose®Synergy1, and Sulindac among Patients at Increased Risk for Sporadic Colorectal Neoplasia”
Procedure: Phone contact
Purpose: Recruitment for study and to facilitate scheduling the clinically indicated colonoscopy
and the study chromoendoscopy
Identification of patients:

Potential patients’ names will be obtained from the GI Neoplasia appointment calendar at Gonda
9East and the colonoscopy appointment schedule from Gonda 9 South, Charlton 8A, and St.
Mary’s Main Alfred Diagnostic Center and surgical and pathology lists.
Potential patients will initially be mailed an invitation letter. However, in some cases there may not
be enough time to contact the patient by mail before their clinic appointment. They will then be
contacted a few days before their scheduled appointment. The study will be explained and
questions will be answered. If the patient verbally consents to the study, the study
chromoendoscopy procedure will be added to the scheduled colonoscopy. The clinically indicated
colonoscopy is usually scheduled at the second day clinic visit. If the patient decides to decline
study participation, the study chromoendoscopy will be canceled.
The study coordinator will meet with the patient at the first day clinic visit to further discuss the
study and obtain written informed consent.
Phone Script

Good morning/afternoon Mr./Ms.__________________. My name is _______________. I am a
study coordinator with the GI Neoplasia Clinic here at Mayo, Rochester. I would like to visit with
you to see if you would be interested in helping us with a study to help prevent colorectal cancer.
You have an appointment to be seen at Mayo Clinic, Rochester on __________________.
(Confirm appointment date with patient). Because you are being seen for_______________and
may possibly be scheduled for colonoscopy you are being considered for the study. Would you
be interested in learning more about this research study? If yes, continue. If no, go to last
paragraph.
Please feel free to ask questions at any time while I explain the study to you.
The purpose of this study is to see what effects (good and bad) of the drugs Atorvastatin and
Sulindac and a food ingredient, Raftilose®Synergy1 have on you and your risk for colon cancer.
Atorvastatin is a drug which has been approved by the Food and Drug Administration (FDA) for
the treatment of high cholesterol. Raftilose®Synergy1 is a commonly used food ingredient that
can help protect against intestinal diseases. Sulindac is a drug which has been approved by the
FDA for the treatment of osteoarthritis and rheumatoid arthritis as well as for acute painful
shoulder and acute gouty arthritis. None of these substances are approved for the treatment of
colon cancer.
This study is being done because at present, there is no effective chemoprevention for people
who are at increased risk for colon polyps and colon cancer.
If you consent to take part in this study, you will be asked to sign a consent form when you come
for your clinic visit. The initial screening will include a medical history, risk factor assessment, and
a physical examination (including body height, weight, body temperature, heart rate, blood
pressure, and breathing rate. You will also have a colonoscopy and dye-spray exam of part of
your colon and rectum with biopsies (removal of tiny pieces of tissue).
Depending on the results of the colonoscopy and dye-spray exam you may or may not be eligible to participate in the study. For example, at least 5 “aberrant crypt foci” or ACF for short, need to be found during the dye-exam. ACFs are minor changes in the lining of the rectum and colon and are believed to possibly be the early form of polyps. The size of the ACFs also determines if you would be eligible for the study. If you continue to be eligible, you will be randomly assigned (as in the flip of a coin) to one of four treatment groups. 1. Atorvastatin 20 mg (two 10 mg pills) once daily by mouth in the morning, with or without 2. Raftilose®Synergy1 6Gm powder twice daily by mouth, in the morning and the evening 3. Sulindac 150 mg pill twice daily by mouth in the morning and the evening, with food 4. Placebo (a preparation without the active drug) powder twice daily by mouth, in the morning and the evening mixed with food or drink. You will need to take the study drug/placebo each day for the entire 6 months of the study. You
will be asked to keep a diary of the amount of study drug you take each day. You will also be
asked to return any unused study drug to your study coordinator at your 3rd month and 6th month
study visits. The study coordinator will also be asking you at these visits about side effects you
may be having and about other medications you may be taking. The study coordinator will be
contacting you by phone at months 1, 2, 4, and 5 to ask about any side effects you may be
having and about other medications you may be taking.
At the 3rd month visit you will have a physical exam (including body height and weight, body
temperature, heart rate, blood pressure, and breathing rate) and routine (study safety) blood
tests. About 3 tablespoons of blood will be drawn.
At the 6th month visit you will have a physical exam (including body height and eight, body
temperature, hear rate, and breathing rate), routine and research blood tests, colonoscopy with
dye-spray exam and biopsies. About 3 tablespoons of blood will be drawn for the routine blood
tests and 4 teaspoons for the research blood tests (optional).
This study will not make your heath better. However, it might reduce your risk for colon cancer.
You will not need to pay for any tests and procedures which are done just for this study. However,
you and your health plan will need to pay for all other tests and procedures that you would
normally have as part of your regular medical care, for example the colonoscopy that you are
scheduled as part of your medical workup at your clinic visit.
.If you finish the study, you will receive $200.00. This money is for travel costs and time you
spend in this study. If you do not complete the study you will receive part of this money.
Do you have any questions or concerns about the study?
Are you interested in participating in this study?
If yes
I would like to ask you a few questions to confirm that you are eligible to participate in the initial
screening for the study.
Have you ever been found to have colorectal polyps or colorectal cancer? If you have had colorectal cancer, have you been cancer free for the last 12 months? Are you currently healthy (do not have any major health problems)? I will arrange a dye-spray exam added to your colonoscopy if you have one scheduled. If you are not scheduled for a colonoscopy, a dye-spray examination of the rectum will be scheduled, if possible, during your clinic visit. When you come for your first day clinic appointment, I will go over the study with you and answer further questions. If you decide to participate, I will ask you to
sign a consent form.
If no
Thank you for your time. Please be assured that your medical care here Mayo will not affected by
whether you participate in this study or not.

Source: http://www.cancerpreventionnetwork.org/Roster_Forms/MAY03103templatephonescript.pdf