RECTUM/SIGMOID COLON/BOWEL,
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1 EMBRACE Follow-up Patient ID: Day Month Year Physician (initials) RECTUM/SIGMOID COLON/BOWEL, morbidity scoring CTC v Diarrhea 1: Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline 2: Increase of 4 6 stools per day over baseline; IV fluids indicated <24hrs; moderate increase in colostomy output compared to baseline; not interfering with ADL 3: Increase of 7 stools per day over baseline; incontinence; IV fluids 24 hrs; hospitalization; severe increase in colostomy output compared to baseline; interfering with ADL 4: Life-threatening consequences (e.g., hemodynamic collapse) 2. Flatulence 2: Moderate 3. Incontinence (anal) 1: Occasional use of pads required 2: Daily use of pads required 3: Interfering with ADL; operative intervention indicated 4: Permanent bowel diversion indicated 4. Proctitis 1: Rectal discomfort, intervention not indicated 2: Symptoms not interfering with ADL; medical intervention indicated 3: Stool incontinence or other symptoms interfering with ADL; operative intervention indicated 4: Life-threatening consequences (e.g., perforation) 5. Bleeding (hemorrhage GI) Anus, intervention (other than iron supplements) not indicated 2: Symptomatic and medical intervention or minor cauterization indicated 6. Stricture/stenosis Anus 1: Asymptomatic radiographic findings only 2: Symptomatic; altered GI function (e.g., altered dietary habits, vomiting, bleeding, diarrhea); iv fluids indicated <24 hrs 3: Symptomatic and severely altered GI function (e.g., altered dietary habits, diarrhea, or GI fluid loss); iv fluids, tube feedings, or TPN indicated 24 hrs; operative intervention indicated 4: Life-threatening consequences; operative intervention requiring complete organ resection (e.g., total colectomy) 7. Fistula Anus 2: Symptomatic; altered GI function (e.g., altered dietary habits, diarrhea, or GI fluid loss); IV fluids indicated <24 hrs 3: Symptomatic and severely altered GI function (e.g., altered dietary habits, diarrhea, or GI fluid loss); IV fluids, tube feedings, or TPN indicated 24 hrs 4: Life-threatening consequences 8. Gastro/intestinal other EMBRACE Follow-up Version 1.1, /5
2 BLADDER, morbidity scoring CTC v Urinary frequency/urgency 1: Increase in frequency or nocturia up to 2 x normal; enuresis 2: Increase >2 x normal but <hourly 3: 1 x/hr; urgency; catheter indicated 10. Incontinence, urinary 1: Occasional (e.g., with coughing, sneezing, etc.), pads not indicated 2: Spontaneous, pads indicated 3: Interfering with ADL; intervention indicated (e.g., clamp, collagen injections) 4: Operative intervention indicated (e.g., cystectomy or permanent urinary diversion) 11. Cystitis 1: Asymptomatic 2: Frequency with dysuria; macroscopic hematuria 3: Transfusion; IV pain medications; bladder irrigation indicated 4: Catastrophic bleeding; major non-elective intervention indicated 12. Bladder spasm 1: Symptomatic, intervention not indicated 2: Symptomatic, antispasmodics indicated 3: Narcotids indicated 4: Major surgical intervention indicated (e.g., cystectomy) 13. Bleeding (Hemorrhage GU) Bladder, intervention (other than iron supplements) not indicated 2: Symptomatic and medical intervention or minor cauterization indicated 14. Stenosis/stricture Bladder 1: Asymptomatic, radiographic or endoscopic findings only 2: Symptomatic but no hydronephrosis, sepsis or renal dysfunction; dilation or endoscopic repair or stent placement indicated 3: Symptomatic and altered organ function (e.g., sepsis or hydronephrosis, or renal dysfunction); operative intervention indicated 4: Life-threatening consequences; organ failure or operative intervention requiring organ resection indicated 15. Fistula Bladder 2: Symptomatic; noninvasive intervention indicated 3: Symptomatic interfering with ADL; invasive intervention indicated 4: Life-threatening consequences; operative intervention requiring partial or full organ resection; permanent urinary diversion 16. Bladder other VAGINA, morbidity scoring CTC v Vaginal dryness 2: Interfering with sexual function; dyspareunia; intervention indicated 18. Vaginal stenosis/length 1: Vaginal narrowing and/or shortening not interfering with function 2: Vaginal narrowing and/or shortening interfering with function 3: Complete obliteration; not surgically correctable 19. Vaginal mucositis 1: Erythema of the mucosa; minimal symptoms 2: Patchy ulcerations; moderate symptoms or dyspareunia 3: Confluent ulcerations; bleeding with trauma; unable to tolerate vaginal exam, sexual intercourse or tampon placement 4: Tissue necrosis; significant spontaneous bleeding; life-threatening consequences 20. Bleeding (hemorrhage GU) 1: Minimal or microscopic bleeding; intervention not indicated 2: Gross bleeding, medical intervention, or urinary tract irrigation indicated EMBRACE Follow-up Version 1.1, /5
3 VAGINA continued, morbidity scoring CTC v Fistula (Vagina cont.) 2: Symptomatic; noninvasive intervention indicated 3: Symptomatic interfering with ADL; invasive intervention indicated 4: Life-threatening consequences; operative intervention requiring partial or full organ resection; permanent urinary diversion 22. Vaginal other Specify category 23. Hormonal therapy 1: oral 2: vaginal 3: oral + vaginal 9: unknown 24. Regular vaginal dilatation 1: yes 9: unknown MUSCLE/SOFT TISSUE/BONE, morbidity scoring CTC v Fibrosis Pelvic left deep connective Pelvic right tissue 1: Increased density, spongy feel 2: Increased density with firmness or tethering 3: Increased density with fixation of tissue; operative intervention indicated; interfering with ADL 4: Life-threatening; disabling; loss of limb; interfering with vital organ function 26. Fracture Pelvic ring - insufficiency Femoral head (e.g., asymptomatic rib fracture on plain x-ray, pelvic insufficiency fracture on MRI, etc.) Symptomatic but nondisplaced; immobilization indicated 2: Symptomatic but non-displaced; immobilization indicated 3: Symptomatic and displaced or open wound with bone exposure; operative intervention indicated 4: Disabling; amputation indicated 27. Muscle/soft tissue/bone other LYMPHATICS, morbidity scoring CTC v Edema: limb 1: 5 10% inter-limb discrepancy in volume or circumference at point of greatest visible difference; swelling or obscuration of anatomic architecture on close inspection; pitting edema 2: >10 30% inter-limb discrepancy in volume or circumference at point of greatest visible difference; readily apparent obscuration of anatomic architecture; obliteration of skin folds; readily apparent deviation from normal anatomic contour 3: >30% inter-limb discrepancy in volume; lymphorrhea; gross deviation from normal anatomic contour; interfering with ADL 4: Progression to malignancy (i.e., lymphangiosarcoma); amputation indicated; disabling 29. Edema: trunk/genital 1: Swelling or obscuration of anatomic architecture on close inspection; pitting edema 2: Readily apparent obscuration of anatomic architecture; obliteration of skin folds; readily apparent deviation from normal anatomic contour 3: Lymphorrhea; interfering with ADL; gross deviation from normal anatomic contour 4: Progression to malignancy (i.e., lymphangiosarcoma); disabling OTHER, NOT COVERED ABOVE, morbidity scoring CTC v Fatigue fatigue over baseline 2: Moderate or causing difficulty performing some ADL 3: Severe fatigue interfering with ADL 4: Disabling 31. Insomnia REMARK: If pain or other symptoms interfere with sleep do not grade as insomnia. Grade primary event(s) causing Insomnia 1: Occasional difficulty sleeping, not interfering with function 2: Difficulty sleeping, interfering with function but not interfering with ADL 3: Frequent difficulty sleeping, interfering with ADL 4: Disabling EMBRACE Follow-up Version 1.1, /5
4 32. Hot flashes 2: Moderate 3: Interfering with ADL 33. Other, specify category and grade a) b) c) d) e) f) ADL: Activities of daily living. The tasks of everyday life. Basic ADLs include eating, dressing, getting into or out of a bed or chair, taking a bath or shower, and using the toilet. Instrumental activities of daily living (IADL) are activities related to independent living and include preparing meals, managing money, shopping, doing housework, and using a telephone. Also called activities of daily living. EMBRACE Follow-up Version 1.1, /5
5 TUMOR STATUS 1. Gynaecological Examination 0: No tumor 1: Tumor present (If present please fill out Follow-Up CRF ) 9: Gyn. Exam. not performed 2. Biopsy from cervix 0: Negative 1: Positive 9: Not done 3. MRI primary tumor 0: No tumor 1: Tumor present (If present please fill out Follow-Up CRF ) 2: Uncertain 9: MRI not performed 4. Imaging Regional/Systemic Status regional systemic 0: No nodes/mets. 1: Node/mets present (If present please fill out Follow-Up CRF ) 2: Uncertainty 9: Investigations not performed 4a. Hydronephrosis 1: left 2: right 3: bilat 9: NA 4b. Insufficiency Fracture 1: yes 9: NA 4c. Other relevant findings 5. Overall Disease Status 0: Local control 1: Persistent Disease 2: Local recurrence 0: Regional control 1: Persistent disease 2: Regional recurrence 0: Systemic control 1: Systemic progression before first FUP 2: Systemic recurrence Local recurrence Regional recurrence Systemic recurrence EMBRACE Follow-up Version 1.1, /5
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