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7.1
Double-blind study
7.11
The patient will be instructed to avoid taking any study
medication for the first seven days, but to complete their
daily questionnaire during this baseline period. For the
subsequent four weeks, patients will be instructed to take
one tablet t.i.d. making sure to take medication from the
correct week. Then they will start another four weeks of
the alternative (blinded) product and complete four more
weeks of questionnaires.
7.12
At study entry, the patient will be given the 10-page set
of Daily Patient Questionnaires (Appendix
III) to be filled out, and the procedure for completing
each page of the set will be carefully explained.
7.121 The page labeled "First Study Week (Baseline)"
should be filled out during the first seven days following
study entry, to document the patient's baseline hot flashes.
Patients should note Appendix
IV outlines the definitions of mild, moderate, severe,
very severe hot flashes.
7.122
The next page labeled "Second Study Week" should be filled
out during the second seven days after study entry and so
on for pages 3-9.
7.123 The 10th (and last) page labeled "Preference"
should be filled out after the first nine weeks of study
participation
7.13
Evaluation procedures
7.131
Each patient will be contacted by telephone week 2, start
of week 5, week 7, and week 9 to document compliance, encourage
completion of the questionnaires, and address problems.
Phone calls may be omitted in those weeks in which the patient
is seen at the NCCTG institution responsible for her primary
care. However, the information obtained must be recorded
on Appendix
V.
7.132
Questionnaires should be returned to the investigator at
the end of blinded treatment (i.e. after the 9th week following
study entry). The patient should be supplied with an addressed/stamped
envelope for returning the forms.
7.14
Emergency unblinding procedures
In
the event of an emergency, call the Randomization Center
at (555) 555-5555 to break the code on Monday through Friday,
8 a.m. to 4:30 p.m. central time. The Rochester Methodist
Pharmacy will be available at any other time at (555) 555-5555.
This is only in the event of an emergency. The pharmacy
staff will require the study number and patient bottle number
to break the code.
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