| |
When considering
what data to collect, there must be a clear understanding of the
objectives as stated in the primary and secondary endpoints. All
data collected must allow for these endpoints to be assessed.
Data collection for this study will involve questionnaires and
participant examinations. Patients will be given a diary to record
daily the presence of pain in their mouth and/or throat, analgesic
use, and ability to eat solids, liquids, or nothing by mouth.
The diaries consist of questions that clearly address the presence
of pain or discomfort, safety and tolerability. Using a 100mm
visual analog scale, patients will mark their degree of pain.
Yes/no questions will be used to assess their days of analgesic
use, ability to eat, safety, and tolerability.
Click here
to see a sample data collection sheet.
Data collection
sheets should be direct and user-friendly. Creating an easy-to-use
survey will increase compliance. Patient compliance is essential
in this study. Hence, the importance of filling out these diaries
should be reinforced through weekly phone calls and evaluated
at the beginning of every chemotherapeutic cycle. Patients need
to answer every question, daily. Patients will be examined and
weighed at the beginning of every cycle to assess weight changes.
Taking time at the beginning of each cycle to touch base with
the patients, answer any questions, and reinforce diary entries
will benefit both the patient and the research staff.
When the data
are collected, the World Health Organization (WHO) Pain Ladder
will be used to assess the daily level of pain experienced by
each patient. The WHO Pain Ladder is as follows:
| 0 = | No
pain medications were needed indicating no pain. |
| 1 = | Nonopoid
+/- adjuvants were needed for mild pain. |
| 2 = | Opioids,
such as Tylenol with codeine +/- adjuvants were needed for
mild to moderate pain. |
| 3 = | Opioids,
such as hydrocodone, oxycodone or morphine +/- adjuvants were
used for moderate to severe pain. |
The WHO Pain
Ladder allows us to have a clear summary of pain on a daily basis.
The WHO Pain Ladder score will be given daily. Pain levels will
be compared and evaluated per study drug group versus placebo.
In addition
to the patient diary, subjects are asked to return to the clinic
weekly for an assessment of mucositis per the WHO and OMAS scales.
The WHO scale was chosen because it is the most commonly used
scale. The OMAS scale was chosen because it was primarily designed
as a research tool. This scale gives an objective report of redness
and ulceration in designated areas of the mouth.
|