BMT CTN 0801 Protocol. Chronic GVHD Provider Survey ENROLLMENT
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1 BMT CTN 0801 Protocol Chronic GVHD Provider Survey ENROLLMENT Instructions: Please score a symptom only if you know or suspect it be related to chronic GVHD. Subjective are acceptable. For example, joint tightness can be scored based on subjective findings despite the absence of objective limitations. Please score present in the last week. Even if they may have resolved with treatment in the past week, if they were present recently and may possibly return, please score them. You will need to complete this survey upon for the patient s baseline visit upon enrollment. Patient Name: MRN: BMT CTN 0801 ID# cgvhd Dx Date: Provider Name (printed): Provider Signature Date of Assessment: BMT CTN 0801 Provider Survey - Enrollment, v 2.0 Page 1 of 11
2 Dermatological Section 1: SKIN Sentinel Lesion? Erythematous rash of any sort Moveable sclerosis Non moveable subcutaneous sclerosis or fasciitis 1. Head/neck/scalp 1- Yes 2- No % % % 2. Anterior torso 1- Yes 2- No % % % 3. Posterior torso 1- Yes 2- No % % % 4. L. upper extremity 1- Yes 2- No % % % 5. R. upper extremity 1- Yes 2- No % % % 6. L. lower extremity, (incl. L 1- Yes 2- No % % % 7. R. lower extremity, (incl. R buttock) 1- Yes 2- No % % % 8. Genitalia not examined 1- Yes 2- No % % % 9. Skin sclerotic changes rmal Thickened Thickened Thickened, Hidebound, with pockets over majority unable to unable to of normal of skin move pinch skin 10. Skin Symptoms <18% BSA with disease signs but NO sclerotic features 11. Fascia rmal Tight with normal areas Clinical Skin Features 19 50% BSA OR involvement with superficial sclerotic features not hidebound (able to pinch) Tight >50% BSA OR deep sclerotic features hidebound (unable to pinch) OR impaired mobility, ulceration or severe pruritus Tight, unable to move 12. Ulcer? 1- Yes Location:. (specify) 14. Largest dimension: (cm) 15. Maculopapular rash 16. Keratosis pilaris 18. Papulosquamous lesions 17. Lichen planus like lesions or icthyosis 19. Poikiloderma 20. Hair involvement 21. Pruritus 22. Nail involvement 23. Other 24. Other, specify: BMT CTN 0801 Provider Survey - Enrollment, v 2.0 Page 2 of 11
3 Section 1: SKIN Region 25. Head, Neck and Scalp 26. Chest 27. Abdomen and Genitals 28. Back and Buttocks 29. Right Arm Sentinel Lesion Grade (see below) % Area of Grade Fraction of Grade 3 or 4 Areas with Erythema (indicate up to what fraction is involved) Grade Description 0 = normal skin 1 = discolored [hypopigmentation, hyperpigmentation, alopecia, erythema, maculopapular rash] 2 = lichenoid plaque, or skin thickened (able to move) 3 = skin thickened with limited motion but able to pinch [scleroderma or fasciae involvement] 4 = hidebound skin, unable to move, unable to pinch BMT CTN 0801 Provider Survey - Enrollment, v 2.0 Page 3 of 11
4 Section 1: SKIN Region Sentinel Lesion Grade (see below) % Area of Grade Fraction of Grade 3 or 4 Areas with Erythema 30. Right Hand 31. Left Arm 32. Left Hand 33. Right Leg and Foot 34. Left Leg and Foot Grade Description 0 = normal skin 1 = discolored [hypopigmentation, hyperpigmentation, alopecia, erythema, maculopapular rash] 2 = lichenoid plaque, or skin thickened (able to move) 3 = skin thickened with limited motion but able to pinch [scleroderma or fasciae involvement] 4 = hidebound skin, unable to move, unable to pinch BMT CTN 0801 Provider Survey - Enrollment, v 2.0 Page 4 of 11
5 Section 2: ROM & MOUTH Please circle this person s current ROM for each joint from 1=poor mobility to 7=full mobility below: 1. Shoulder 2. Elbow 3. Wrist and fingers 4. Foot Dorsiflexion 5. Mouth Mild with disease signs but not limiting oral intake significantly Moderate with signs with partial limitation of oral intake Severe with disease signs on examination with major limitation of oral intake 6. Erythema ne Mild erythema OR Moderate ( 25%) Severe erythema ( 25%) Moderate erythema (<25%) OR Severe erythema (<25%) Mouth 7. Lichenoid ne Hyperkeratotic changes (<25%) Hyperkeratotic changes (25 50%) Hyperkeratotic changes (>50%) 8. Ulcers ne ne Ulcers involving ( 20%) Severe ulcerations (>20%) 9. Mucoceles (of lower labia and soft palate only) ne 1 5 mucoceles 6 10 scattered mucoceles Over 10 mucoceles 10. Mouth Pain Food sensitivity Pain requiring narcotics Unable to eat BMT CTN 0801 Provider Survey - Enrollment, v 2.0 Page 5 of 11
6 Section 3: GASTROINTESTINAL 1. GI Tract 2. Esophagus Dysphagia OR Odynophagia Symptoms Symptoms such as associated dysphagia, with mild to anorexia, moderate nausea, weight loss vomiting, (5 15%) abdominal pain or diarrhea without significant weight loss (<5%) esophageal Occasional dysphagia or odynophagia with solid food or pills during the past week Intermittent dysphagia or odynophagia with solid food or pills (but not for liquids or soft foods) during the past week Symptoms associated with significant weight loss >15%, requires nutritional supplement for most calorie needs OR esophageal dilation Dysphagia or odynophagia for almost all oral intake, on almost every day of the past week Gastrointestinal 3. Upper GI Early satiety OR Anorexia OR Nausea & vomiting Mild, occasional with little reduction in oral intake during the past week Moderate, intermittent throughout the day, with some reduction in oral intake, during the past week More severe or persistent throughout the day, with marked reduction in oral intake, on almost every day of the past week 4. Lower GI Diarrhea loose or liquid stools during the past week Occasional loose or liquid stools, on some days during the past week Intermittent loose or liquid stools through out the day, on almost every day of the past week without requiring intervention to prevent or correct volume depletion Voluminous diarrhea on almost every day of the past week requiring intervention to prevent or correct volume depletion BMT CTN 0801 Provider Survey - Enrollment, v 2.0 Page 6 of 11
7 Section 4: OTHER ORGANS 1. Eye Mild dry eye Moderate dry eye not partially affecting ADL affecting ADL (requiring eye (requiring eye drops drops <3x per >3x per day or day) OR punctual plugs) asymptomatic WITHOUT vision signs of keratoconjunctivitis impairment sicca Severe dry eye significantly affecting ADL (special eyewear to relieve pain) OR unable to work because of ocular OR loss of vision caused by keratoconjunctivitis sicca 2. Joints and Fascia Mild tightness of arms or legs, normal or mild decreased range of motion (ROM) AND not affecting ADL Tightness of arms or legs OR joint contractures, erythema thought due to fasciitis, moderate decrease ROM AND mild to moderate limitation of ADL Contracture WITH significant decrease of ROM AND significant limitation of ADL (unable to tie shoes, button shirts, dress self etc.) 3. Genital Tract GYN Exam or N/A (males) NB still required Symptomatic with mild distinct signs on exam AND no effect on coitus and minimal discomfort with GYN exam Symptomatic with distinct signs on exam AND with mild dyspareunia or discomfort with GYN exam Symptomatic WITH advanced signs (stricture, labia agglutination or severe ulceration) AND severe pain with coitus or inability to insert vaginal spectrum 4. Lung Mild (shortness of breath after climbing one flight of steps) Moderate (shortness of breath after walking on flat ground) Severe (shortness of breath at rest; requiring O2) 5. Other Organ Specify organ1: 6. Other Organ Specify organ2: effect on ADL effect on ADL Mild effect on ADL Mild effect on ADL Moderate effect on ADL Moderate effect on ADL Severe effect on ADL Severe effect on ADL BMT CTN 0801 Provider Survey - Enrollment, v 2.0 Page 7 of 11
8 Section 5: OVERALL STATUS 1. Please rate the severity of this person s chronic GVHD on the two scales below: a. ne (1) Mild (2) Moderate (3) Severe (4) cgvhd are not at all severe cgvhd are most severe as possible b Was therapeutic regimen changed? 1 Yes 2 No If yes, indicate how it was changed below. a. Adjust levels of medications 1 Yes 2 No b. Enroll on clinical trial 1 Yes 2 No c. Worsening of 1 Yes 2 No d. No improvement in 1 Yes 2 No e. Toxicity 1 Yes 2 No f. New 1 Yes 2 No g. Improvement in 1 Yes 2 No h. Disease relapse 1 Yes 2 No i. Stable 1 Yes 2 No 3. Does this person currently have: 0 GVHD 1 Late acute GVHD 2 Overlap acute and chronic GVHD 3 Classic chronic GVHD 4. Sentinel Organ (If more than one, please rank with Indicate which organ system will guide your treatment decisions 1 being first and 4 being last) a. Skin 0 No, will not guide b. Joints 0 No, will not guide c. Fascia 0 No, will not guide d. Lung 0 No, will not guide e. Urogenital 0 No, will not guide f. Liver 0 No, will not guide g. Mouth 0 No, will not guide h. Esophagus 0 No, will not guide i. Lower GI 0 No, will not guide j. Other 0 No, will not guide k. Specify other BMT CTN 0801 Provider Survey - Enrollment, v 2.0 Page 8 of 11
9 Section 6: OTHER INDICATORS, CLINICAL MANIFESTATIONS OR SEVERE COMPLICATIONS RELATED TO CHRONIC GVHD Other indicators, clinical manifestations or severe complications related to chronic GVHD Past, Never Mild Moderate Severe not now (0) (2) (3) (4) (1) 1. Pleural Effusion(s) 2. Bronchiolitis obliterans 3. Bronchiolitis obliterans organizing pneumonia 4. Nephrotic syndrome 5. Malabsorption 6. Esophageal stricture or web 7. Ascites (serositis) 8. Myasthenia Gravis 9. Peripheral Neuropathy 10. Polymyositis 11. Pericardial Effusion 12. Cardiomyopathy 13. Cardiac conduction defects 14. Coronary artery involvement 15a. Other 1, please specify: 15b. Other 2, please specify: 15c. Other 3, please specify: Please continue to the next page BMT CTN 0801 Provider Survey - Enrollment, v 2.0 Page 9 of 11
10 Section 6: OTHER INDICATORS, CLINICAL MANIFESTATIONS OR SEVERE COMPLICATIONS RELATED TO CHRONIC GVHD 16. Infection ne Mild, topical or no therapy required Moderate, localized, requiring oral treatment If 2, 3, or 4, then select one: Pending lab report Unidentified organism Severe, systemic infection requiring IV anti infective, mold active oral antifungal or hospitalization Lifethreatening infection Identified organism, specify: 17. Peripheral Edema? ne (0) Trace (9) Section 7: FUNCTIONAL TESTS (may be assessed by the Provider or other personnel at the center) 1. Two Minute Walk Test - assessed by: Date Total Distance walked in two minutes feet 2. Grip Strength - assessed by: Date Trial #1 lbs or kg Trial #2 lbs or kg Trial #3 lbs or kg 3. Schirmer s Eye Exam - assessed by: Date RIGHT Eye (OD) mm LEFT Eye (OS) mm BMT CTN 0801 Provider Survey - Enrollment, v 2.0 Page 10 of 11
11 BMT CTN 0801 Protocol Chronic GVHD Provider Survey ENROLLMENT For office use only Study ID Initials (First, Last) Date completed: Date received: Visit Number- Day 0 Date entered: Contact Person at Site: Phone Number: The BMT CTN 0801 Provider Survey is complete. Please provide to the data coordinator to enter in AdvantageEDC and save the original copy in the patient s research chart. BMT CTN 0801 Provider Survey - Enrollment, v 2.0 Page 11 of 11
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