Chronic GVHD Provider Survey

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?
Erythematous
rash of any sort
Moveable
sclerosis
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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 1-Yes 2-No % % %
buttock)
8. Genitalia not examined 1-Yes 2-No % % %
9. Skin
sclerotic
changes
10. Skin
Score
11. Fascia
Clinical Skin Features
12. Ulcer? 1- Yes
2- No
0 1 2 3 4
Normal Thickened
with pockets
of normal
skin
Thickened
over majority
of skin
Thickened,
unable to
move
0 1 2 3
No Symptoms 50% BSA OR deep
sclerotic features
“hidebound” (unable
to pinch) OR
impaired mobility,
ulceration or severe
pruritus
Tight Tight, unable to move
14. Largest dimension: (cm)
15. Maculopapular rash 1‐ Yes 2‐ No 16. Keratosis pilaris
18. Papulosquamous lesions
1‐ Yes 2‐ No
17. Lichen planus‐like lesions 1‐ Yes 2‐ No or icthyosis
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:

Region
25. Head,
Neck and Scalp
26. Chest
27. Abdomen
and Genitals
28. Back and
Buttocks
29. Right Arm
Sentinel
Lesion
1‐ Yes 2‐ No
1‐ Yes 2‐ No
1‐ Yes 2‐ No
1‐ Yes 2‐ No
1‐ Yes 2‐ No
Section 1: SKIN
Grade
(see below)
0 1‐ Yes 2‐ No %
1 1‐ Yes 2‐ No %
2 1‐ Yes 2‐ No %
% Area of Grade
Fraction of
Grade 3 or 4 Areas with
Erythema
(indicate up to what fraction is
involved)
3 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
4 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
Total = 100 %
0 1‐ Yes 2‐ No %
1 1‐ Yes 2‐ No %
2 1‐ Yes 2‐ No %
3 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
4 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
Total = 100 %
0 1‐ Yes 2‐ No %
1 1‐ Yes 2‐ No %
2 1‐ Yes 2‐ No %
3 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
4 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
Total = 100 %
0 1‐ Yes 2‐ No %
1 1‐ Yes 2‐ No %
2 1‐ Yes 2‐ No %
3 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
4 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
Total = 100 %
0 1‐ Yes 2‐ No %
1 1‐ Yes 2‐ No %
2 1‐ Yes 2‐ No %
3 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
4 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
Total = 100 %
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

Region
30. Right Hand
31. Left Arm
32. Left Hand
33. Right Leg
and Foot
34. Left Leg and
Foot
Sentinel
Lesion
1‐ Yes 2‐ No
1‐ Yes 2‐ No
1‐ Yes 2‐ No
1‐ Yes 2‐ No
1‐ Yes 2‐ No
Section 1: SKIN
Grade
(see below)
0 1‐ Yes 2‐ No %
1 1‐ Yes 2‐ No %
2 1‐ Yes 2‐ No %
% Area of Grade
Fraction of
Grade 3 or 4 Areas with Erythema
3 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
4 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
Total = 100 %
0 1‐ Yes 2‐ No %
1 1‐ Yes 2‐ No %
2 1‐ Yes 2‐ No %
3 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
4 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
Total = 100 %
0 1‐ Yes 2‐ No %
1 1‐ Yes 2‐ No %
2 1‐ Yes 2‐ No %
3 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
4 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
Total = 100 %
0 1‐ Yes 2‐ No %
1 1‐ Yes 2‐ No %
2 1‐ Yes 2‐ No %
3 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
4 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
Total = 100 %
0 1‐ Yes 2‐ No %
1 1‐ Yes 2‐ No %
2 1‐ Yes 2‐ No %
3 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
4 1‐ Yes 2‐ No % 0 ¼ ½ ¾ 1
Total = 100 %
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

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 No
symptoms
Mouth
0 1 2 3
Mild symptoms
with disease
signs but not
limiting oral
intake
significantly
6. Erythema None Mild erythema
OR
Moderate
erythema (

1. GI Tract Score
Gastro‐
intestinal
2. Esophagus
Dysphagia OR
Odynophagia
3. Upper GI
Early satiety OR
Anorexia
OR
Nausea &
vomiting
4. Lower GI
Diarrhea
Section 3: GASTROINTESTINAL
No
symptoms
0 1 2 3
No
esophageal
symptoms
No
symptoms
No loose or
liquid stools
during the
past week
Symptoms
such as
dysphagia,
anorexia,
nausea,
vomiting,
abdominal pain
or diarrhea
without
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
More severe
or persistent
symptoms
throughout the
day, with
marked
reduction in
oral intake, on
almost every day
of the past week
Voluminous
diarrhea on
almost every day
of the past week
requiring
intervention to
prevent or
correct volume
depletion
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1. Eye
Score
2. Joints
and
Fascia
Score
3. Genital
Tract
Score
No GYN
Exam or N/A
(males)
NB Score still
required
4. Lung
Score
5. Other
Organ
Score
Specify organ1:
6. Other
Organ
Score
Specify organ2:
No
symptoms
No
symptoms
No
symptoms
No
symptoms
Section 4: OTHER ORGANS
0 1 2 3
No effect on
ADL
____________
No effect on
ADL
____________
Mild dry eye
symptoms not
affecting ADL
(requiring eye
drops 3x per day or
punctual plugs)
WITHOUT vision
impairment
Tightness of arms or
legs OR joint
contractures,
erythema thought
due to fasciitis,
moderate decrease
ROM AND mild to
moderate limitation
of ADL
Symptomatic with
distinct signs on
exam AND with
mild dyspareunia or
discomfort with
GYN exam
Moderate symptoms
(shortness of breath
after walking on flat
ground)
Moderate effect
on ADL
Moderate effect on
ADL
Severe dry eye
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
Contracture WITH
significant decrease
of ROM AND
significant limitation
of ADL (unable to tie
shoes, button shirts,
dress self etc.)
Symptomatic WITH
advanced signs
(stricture, labia
agglutination or
severe ulceration)
AND severe pain
with coitus or
inability to insert
vaginal spectrum
Severe symptoms
(shortness of breath
at rest; requiring O2)
Severe effect on ADL
Severe effect on ADL
BMT CTN 0801 Provider Survey - Enrollment, v 2.0 Page 7 of 11

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) Severe (4)
b.
cGVHD symptoms are not at all severe cGVHD symptoms are most severe as possible
0 1 2 3 4 5 6 7 8 9 10
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 0‐No, will not guide 1‐ 2‐ 3‐ 4‐
b. Joints 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
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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
16. Infection
0 1 2 3 4
None Mild,
topical or
no
therapy
required
If 2, 3, or 4, then select one:
Moderate, localized,
requiring oral
treatment
Pending
lab
report
Unidentified
organism
Severe,
systemic
infection
requiring IV
anti‐infective,
mold‐active
oral antifungal
or
hospitalization
Life‐
threatening
infection
Identified organism, specify:
17. Peripheral Edema? None (0) 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 Date entered:
Contact Person at Site:
Phone Number:
Date received:
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