Download Chronic GVHD Protocol - Fred Hutchinson Cancer Research Center

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 symptoms are acceptable. For example, joint tightness can be scored based on
subjective findings despite the absence of objective limitations.
Please score symptoms 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
Section 1: SKIN
Dermatological Sentinel Lesion? 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 % % % 1-Yes 2-No 7. R. lower extremity, (incl. R buttock)
8. Genitalia  not examined 1-Yes 2-No % % % % % % 0
1
 Normal 9. Skin sclerotic changes 2
 Thickened 0 3
 Thickened with pockets of normal skin Moveable sclerosis Non‐moveable subcutaneous sclerosis or fasciitis Erythematous rash of any sort  Thickened, over majority of skin 1 4
 Hidebound, unable to move unable to pinch 2 10. Skin Score  No Symptoms  <18% BSA with 11. Fascia  Normal  19‐50% BSA OR disease signs but NO sclerotic features  Tight with normal 3  >50% BSA OR deep involvement with superficial sclerotic features “not hidebound” (able to pinch)  Tight sclerotic features “hidebound” (unable to pinch) OR impaired mobility, ulceration or severe pruritus  Tight, unable to move areas Clinical Skin Features 12. Ulcer? 1- Yes
13. Location: 2- No . (specify) 14. Largest dimension: (cm) 15. Maculopapular rash 17. Lichen planus‐like lesions 1‐ Yes 2‐ No 1‐ Yes 2‐ No 16. Keratosis pilaris 18. Papulosquamous lesions or icthyosis 1‐ Yes 2‐ No 1‐ Yes 2‐ No 19. Poikiloderma 1‐ Yes 2‐ No 20. Hair involvement 1‐ Yes 2‐ No 21. Pruritus 1‐ Yes 2‐ No 22. Nail involvement 1‐ Yes 2‐ No 23. Other 1‐ Yes 2‐ No 24. Other, specify: BMT CTN 0801 Provider Survey - Enrollment, v 2.0
Page 2 of 11
Section 1: SKIN
Sentinel Lesion Region Grade (see below) % Area of Grade
Fraction of Grade 3 or 4 Areas with Erythema (indicate up to what fraction is involved) 25. Head, Neck and Scalp 26. Chest 1‐ Yes 2‐ No 1‐ Yes 2‐ No 27. Abdomen and Genitals 1‐ Yes 2‐ No 28. Back and Buttocks 29. Right Arm
1‐ Yes 2‐ No 1‐ Yes 2‐ No 0 1‐ Yes 2‐ No 1 1‐ Yes 2‐ No 2 1‐ Yes 2‐ No 3 1‐ Yes 2‐ No 4 1‐ Yes 2‐ No Total = 0 1‐ Yes 2‐ No 1 1‐ Yes 2‐ No 2 1‐ Yes 2‐ No 3 1‐ Yes 2‐ No 4 1‐ Yes 2‐ No Total = 0 1‐ Yes 2‐ No 1 1‐ Yes 2‐ No 2 1‐ Yes 2‐ No 3 1‐ Yes 2‐ No 4 1‐ Yes 2‐ No Total = 0 1‐ Yes 2‐ No 1 1‐ Yes 2‐ No 2 1‐ Yes 2‐ No 3 1‐ Yes 2‐ No 4 1‐ Yes 2‐ No Total = 0 1‐ Yes 2‐ No 1 1‐ Yes 2‐ No 2 1‐ Yes 2‐ No 3 1‐ Yes 2‐ No 4 1‐ Yes 2‐ No Total = % % % % % 100 % % % % % % 100 % % % % % % 100 % % % % % % 100 % % % % % % 100 % 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1
0 ¼ ½ ¾ 1 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
Section 1: SKIN
Region Sentinel Lesion 30. Right Hand 1‐ Yes 2‐ No 31. Left Arm 1‐ Yes 2‐ No 32. Left Hand 1‐ Yes 2‐ No 33. Right Leg and Foot 34. Left Leg and Foot 1‐ Yes 2‐ No 1‐ Yes 2‐ No Grade (see below) % Area of Grade
Fraction of Grade 3 or 4 Areas with Erythema 0 1‐ Yes 2‐ No 1 1‐ Yes 2‐ No 2 1‐ Yes 2‐ No 3 1‐ Yes 2‐ No 4 1‐ Yes 2‐ No % % % % % Total = 0 1‐ Yes 2‐ No 1 1‐ Yes 2‐ No 2 1‐ Yes 2‐ No 3 1‐ Yes 2‐ No 4 1‐ Yes 2‐ No 100 % % % % % % Total = 0 1‐ Yes 2‐ No 1 1‐ Yes 2‐ No 2 1‐ Yes 2‐ No 3 1‐ Yes 2‐ No 4 1‐ Yes 2‐ No 100 % % % % % % Total = 0 1‐ Yes 2‐ No 1 1‐ Yes 2‐ No 2 1‐ Yes 2‐ No 3 1‐ Yes 2‐ No 4 1‐ Yes 2‐ No 100 % % % % % % Total = 0 1‐ Yes 2‐ No 1 1‐ Yes 2‐ No 2 1‐ Yes 2‐ No 3 1‐ Yes 2‐ No 4 1‐ Yes 2‐ No 100 % % % % % % 100 % Total = 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 0 ¼ ½ ¾ 1 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
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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 Score 0  No symptoms 6. Erythema  None 7. Lichenoid  None 8. Ulcers  None 1  Mild symptoms with disease signs but not limiting oral intake significantly  Mild erythema symptoms with signs with partial limitation of oral intake  Moderate (≥25%) Moderate erythema (<25%) OR  Hyperkeratotic  None 9. Mucoceles  None (of lower labia and soft palate only)  1‐5 mucoceles symptoms BMT CTN 0801 Provider Survey - Enrollment, v 2.0
 Severe symptoms with disease signs on examination with major limitation of oral intake  Severe erythema (≥25%)  Hyperkeratotic  Hyperkeratotic changes (25‐50%)  Ulcers  6‐10 scattered mucoceles  No 3 Severe erythema (<25%) involving (≤20%) 10. Mouth Pain  Moderate OR changes (<25%) Mouth 2 changes (>50%)  Severe ulcerations (>20%)  Over 10 mucoceles  Food sensitivity  Pain requiring  Unable to eat narcotics Page 5 of 11
Section 3: GASTROINTESTINAL
1. GI Tract Score 0  No symptoms 2. Esophagus  No  Dysphagia OR  Odynophagia esophageal symptoms 1  Symptoms such as dysphagia, anorexia, nausea, vomiting, abdominal pain or diarrhea without significant weight loss (<5%)  Occasional dysphagia or odynophagia with solid food or pills during the past week 2  Symptoms 3  Symptoms associated with mild to moderate weight loss (5‐15%) associated with significant weight loss >15%, requires nutritional supplement for most calorie needs OR esophageal dilation  Intermittent  Dysphagia or dysphagia or odynophagia with solid food or pills (but not for liquids or soft foods) during the past week odynophagia for almost all oral intake, on almost every day of the past week 3. Upper GI Gastro‐
intestinal  Early satiety OR  Anorexia OR  Nausea & vomiting  No symptoms  Mild,  Moderate, occasional symptoms with little reduction in oral intake during the past week  More severe intermittent symptoms throughout the day, with some reduction in oral intake, during the past week or persistent symptoms throughout the day, with marked reduction in oral intake, on almost every day of the past week 4. Lower GI  Diarrhea  No loose or liquid stools during the past week  Occasional  Intermittent  Voluminous loose or liquid stools, on some days during the past week 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 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
Section 4: OTHER ORGANS
0 1. Eye Score  No 2. Joints and Fascia Score  No 1  Mild dry eye symptoms 2  Moderate dry eye symptoms not affecting ADL (requiring eye drops <3x per day) OR asymptomatic signs of kerato‐
conjunctivitis sicca 3  Severe dry eye symptoms partially affecting ADL (requiring eye drops >3x per day or punctual plugs) WITHOUT vision impairment symptoms significantly affecting ADL (special eyewear to relieve pain) OR unable to work because of ocular symptoms OR loss of vision caused by kerato‐
conjunctivitis sicca  Mild tightness of  Tightness of arms or arms or legs, normal or mild decreased range of motion (ROM) AND not affecting ADL legs OR joint contractures, erythema thought due to fasciitis, moderate decrease ROM AND mild to moderate limitation of ADL symptoms  Contracture WITH significant decrease of ROM AND significant limitation of ADL (unable to tie shoes, button shirts, dress self etc.) 3. Genital  No  Symptomatic with  Symptomatic with symptoms Tract Score mild distinct signs on exam AND no effect on coitus and minimal discomfort with GYN exam  No GYN Exam or N/A (males) NB Score still required 4. Lung Score  Symptomatic WITH distinct signs on exam AND with mild dyspareunia or discomfort with GYN exam advanced signs (stricture, labia agglutination or severe ulceration) AND severe pain with coitus or inability to insert vaginal spectrum  No  Mild symptoms symptoms (shortness of breath after climbing one flight of steps)  Moderate symptoms (shortness of breath after walking on flat ground)  Severe symptoms (shortness of breath at rest; requiring O2) 5. Other Organ Score  No effect on  Mild effect on ADL ADL  Moderate effect  Severe effect on ADL on ADL Specify organ1: ____________ 6. Other Organ Score  No effect on  Mild effect on ADL ADL  Moderate effect on  Severe effect on ADL ADL Specify organ2: ____________ BMT CTN 0801 Provider Survey - Enrollment, v 2.0
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Section 5: OVERALL STATUS
1. Please rate the severity of this person’s chronic GVHD on the two scales below: a. 
 None (1)
 Mild (2)
 Moderate (3)
cGVHD symptoms are not at all severe
 Severe (4)
cGVHD symptoms are most severe as possible
b. 
0
1
2
3
4
5
6
7
8
9
2. 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 symptoms 1‐Yes 2‐No d. No improvement in symptoms 1‐Yes 2‐No e. Toxicity 1‐Yes 2‐No f. New symptoms 1‐Yes 2‐No g. Improvement in symptoms 1‐Yes 2‐No h. Disease relapse 1‐Yes 2‐No i. Stable 1‐Yes 2‐No 3. Does this person currently have: 0‐ No 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 b. Joints 0‐No, will not guide 1‐ 2‐ 3‐ 4‐ 0‐No, will not guide 1‐ 2‐ 3‐ 4‐ c. Fascia 0‐No, will not guide 1‐ 2‐ 3‐ 4‐ d. Lung 0‐No, will not guide 1‐ 2‐ 3‐ 4‐ e. Urogenital 0‐No, will not guide 1‐ 2‐ 3‐ 4‐ f. Liver 0‐No, will not guide 1‐ 2‐ 3‐ 4‐ g. Mouth 0‐No, will not guide 1‐ 2‐ 3‐ 4‐ h. Esophagus 0‐No, will not guide 1‐ 2‐ 3‐ 4‐ i. Lower GI 0‐No, will not guide 1‐ 2‐ 3‐ 4‐ j. Other 0‐No, will not guide 1‐ 2‐ 3‐ 4‐ k. Specify other BMT CTN 0801 Provider Survey - Enrollment, v 2.0
Page 8 of 11
10
Section 6: OTHER INDICATORS, CLINICAL MANIFESTATIONS
OR SEVERE COMPLICATIONS RELATED TO CHRONIC GVHD
Other indicators, clinical manifestations or severe complications related to chronic GVHD Never (0) Past, not now (1) Mild (2) Moderate
(3) Severe
(4) 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
Section 6: OTHER INDICATORS, CLINICAL MANIFESTATIONS
OR SEVERE COMPLICATIONS RELATED TO CHRONIC GVHD
0 16. Infection 
None 1 2  Mild,  Life‐
systemic threatening infection infection requiring IV anti‐infective, mold‐active oral antifungal or hospitalization  Unidentified  Identified organism, specify: organism requiring oral treatment  Pending If 2, 3, or 4, then select one: 17. Peripheral Edema?  None (0) 4  Moderate, localized,  Severe, topical or no therapy required 3 lab report  Trace (9)  1+  2+  3+  4+ 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
BMT CTN 0801 Protocol
Chronic GVHD Provider Survey
ENROLLMENT
For office use only
Study ID
Initials (First, Last)
Date completed:
Visit Number- Day 0
Contact Person at Site:
Date received:
Date entered:
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