Page 59 - Read Online
P. 59

Webster et al. J Cancer Metastasis Treat 2020;6:8  I  http://dx.doi.org/10.20517/2394-4722.2019.38                         Page 7 of 14

               Table 1. Primary symptom list
                I have diarrhea (diarrhoea)              I have pain in my chest
                I have to limit my activities because of diarrhea (diarrhoea)*  I feel lightheaded (dizzy)
                I must move my bowels frequently to avoid accidents*  My eyesight is blurry
                I am constipated                         I have trouble with coordination
                I am bothered by reflux or heartburn     I am able to maintain my balance*
                I have pain in my stomach area           I have pain in my joints
                Stomach pain interferes with my daily functioning*  I have stiffness or tightness in my joints
                I have swelling in my stomach area       Joint stiffness or tightness limits my usual activities
                I feel bloated*                          Joint pain limits my usual activities
                I have nausea                            I have weakness in my arms or legs
                I have been vomiting                     I am bothered by muscle pains
                I have noticed blood in my stool         I am bothered by swelling in certain areas of my body
                I have a loss of appetite                I get headaches
                I feel fatigued                          I am bothered by headaches*
                My fatigue keeps me from doing the things I want to do*  I urinate more frequently than usual
                I have a lack of energy                  I am losing weight
                I feel tired*                            I am bothered by a change in weight*
                My skin (or scalp) itches                I have had fevers
                My skin (or scalp) is dry or “flaky”     I am bothered by fevers (episodes of high body temperature)*
                I am bothered by dry skin                I have had chills
                I am bothered by cracking or peeling of my skin  I am bothered by chills*
                I am bothered by blistering of my skin   I feel nervous
                I am bothered by vitiligo (white patches on my skin)  I have episodes of heart racing
                The skin on my feet hurts                I am bothered by sweating
                Pain on the bottom of my feet interferes with my walking  My eyes are dry
                I have mouth sores                       My eyes feel sandy or gritty
                I am bothered by a skin rash             My mouth is dry
                The skin on my hands hurts               My mouth and throat are dry*
                I am bothered by a change in my skin’s sensitivity to the sun  I am bothered by dry mouth*
                I have pain in my hands or feet when I am exposed to cold   I have pain in my sinus area
                temperatures
                I have been short of breath              I am bothered by side effects of treatment
                I have been coughing                     I am bothered by new allergy-like reactions (e.g., to foods, insects, pollen)
                I have been wheezing (whistling sound when I breathe)  I am bothered by short-term treatment reactions that I experience
                                                         immediately after, or within 24 h of, an infusion (such as chills, dizziness,
                                                         hives, rashes lasting no more than 24 h)
               *Designates a supplemental item


               For symptoms where there was no corresponding FACIT item, we adapted a similar, existing item (e.g.,
               replaced “eyes” with “mouth” for item HN3 “My mouth is dry”) or wrote a new item [e.g., “I am bothered
               by vitiligo (white patches on my skin)”].


               We then asked our expert panel to review selected PRO items, and identify the most relevant ones for
               ICM treatment assessment. We used consensus and input from our internal team of measure developers to
               refine the list to 47 items covering 32 symptoms, and then sent it back to the panel members for a second
               iteration of review. During this review our panel helped: (1) identify items that were a misfit or symptoms
               still missing from the list; (2) confirm that item text targeted desired symptom assessment; and (3) refine
               item wording for newly written items as needed. Again, we used consensus and internal team input to hone
               the list to 53 primary and 13 supplemental items, and then sent it back to our panel for one final review to
               confirm content and identify any lingering item(s) that should be omitted or symptom(s) that should be
               included.


               The final Primary Symptom List includes 66 items assessing 48 symptoms deemed common or clinically
               relevant to ICM adverse event symptom monitoring. Symptoms include: gastrointestinal (diarrhea,
               constipation, reflux/heartburn, abdominal pain, abdominal swelling, abdominal bloating, nausea, vomiting,
   54   55   56   57   58   59   60   61   62   63   64