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11.0
Treatment Evaluation
11.1
The effects of treatment will primarily be evaluated by objective
evidence of appetite based
on patient-completed
questionnaires. Additionally, we will evaluate patient weight
changes (absolute change, BMI and PIW) in those without clinical
evidence of ascites or edema.
11.2
The patient questionnaire (Appendix
I), FAACT questionnaire (not available Online), and weight
monitoring record (Appendix
II) will be given to patients by the oncology nurse and/or
clinical research associate (per membership-determined procedures).
Additionally, written protocol instructions will be given to each
patient (Appendix
III). Patient questionnaires and weight monitoring records
will be completed every week for the first month of treatment
and monthly thereafter. These records will be returned to the
oncology nurse and/or clinical research associate and will be
mailed to the NCCTG Operations Office every month.
11.3
The patient questionnaire (Appendix
I) used for this study has been utilized on over 1000 patients
on four consecutive NCCTG clinical protocols. These appear to
be reliable and valid on the basis of internal consistency among
related questions and the appropriate relationship between the
questionnaire answers and the results of serial body weight determinations
in these past study patients.
11.4
An event-monitoring form is to be sent to the Operations Office
every 6 months following the time of study completion for 2 years
from on study.
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