The Myelodysplasia Transplantation-Associated Outcomes (MDS-TAO) Study
Conditions: Myelodysplastic Syndromes (MDS)
Sponsor: Dana-Farber Cancer Institute

TITLE: The Myelodysplasia Transplantation-Associated Outcomes (MDS-TAO) Study 
NCT NUMBER: NCT02390414 
DOCUMENT DATE: 05/18/2018 

Status Page 
 
 
 
PROTOCOL 11-056 
 
 
 
 
 
Permanent   
Closed to New Accrual  
 
 
 
 
 
 
 
 
 
 
 
Closure Effective Date: 05/18/2018 
No new subjects may be enrolled in the study as described above.  
Any questions regarding this closure should be directed to the 
study’s Principal Investigator 
 
 
 
 

 
 
 
 
 
 
 
Office for Human Research Studies 
 
DANA-FARBER / HARVARD CANCER CENTER 
Version: 10.03.14a 
 
 
Protocol Front Sheet 
DFCI Protocol No.: 11-056  
 
1.  PROTOCOL TITLE AND VERSION  
 
Title: The Myelodysplasia Transplantation-Associated Outcomes (MDS-TAO) Study 
Protocol Version No./ Date: No. 5, 7/9/2014 
Sponsor Study Number: N/A 
 
2.  DF/HCC STUDY CONTACT INFORMATION 
 
Primary Study Contact: Maxwell Teschke  
Email:  maxwellp_teschke@dfci.harvard.edu 
Phone:  617-582-7396 
 
INVESTIGATORS:  (List only those under DFCI IRB, i.e., from institutions listed in Section 6 below) 
Overall PI: 
Dr. Gregory Abel, MD, MPH 
Phone: 617-632-2304 
Institution(s): 
DFCI 
Site Responsible PI: 
Dr. Gregory Abel, MD, MPH 
Dr. Yi-Bin Chen, MD 
Dr. David E. Avigan, MD 
Phone: 617-632-2304 
617-724-1124 
617-667-9920 
Institution(s): 
DFCI 
MGH 
BIDMC 
 
 
3.  DRUG / DEVICE INFORMATION    N/A: 
  
 
 Drug(s), Biologic(s):        
 Device(s) Name:        
Provided by:       
IND Exempt: 
        ‐or‐ 
IND#:            Holder Type: [pull down]    
IND Holder Name:        
Provided by:      
IDE Exempt: 
        ‐or‐ 
IDE #:            Holder Type: [pull down]    
IDE Holder Name:        
 
4.  PROTOCOL COORDINATION, FUNDING, PHASE, MODE, TYPE ETC. 
 
Regulatory Sponsor: 
Funding/Support (check all that apply): 
Phase: N/A 
DF/HCC Investigator        
 Industry:       
 
 
 Federal Organization:       
Multi-Center (i.e., non-DF/HCC site participation): 
Cancer Related:  Yes   If yes: 
      Grant #:       
No 
Primary Disease Program: 
 Internal Funding: DFCI 
 
Leukemia 
 Non-Federal:       
Protocol Type: Other 
or 
 Other:       
If Ancillary, provide parent protocol #:       
Primary Discipline Based Program: 
 
 
Outcomes Research 
CTEP Study: No 
 
 
 
 
Protocol Involves (check all that apply as listed in the protocol document, even if not part of the research but is mandated by the protocol document): 
 Chemotherapy 
 Hormone Therapy 
 Medical Record Review 
 Immunotherapy 
 Vaccine 
 Questionnaires/Surveys/Interviews 
 Surgery 
 Data Repository 
 Radiological Exams 
 Bone Marrow/Stem Cell Transplant 
 Exercise/Physical Therapy 
 Required Biopsy Study 
 Cell Based Therapy 
 Genetic Studies 
 Human Embryonic Stem Cell 
 Gene Transfer (use of recombinant DNA) 
 Human Material Banking 
 Quality of Life 
 Radiation Therapy 
 Human Material Collection 
 Other:       
 
5.  SUBJECT POPULATION (also applies to medical record review and specimen collection studies) 
 
Total Study-Wide Enrollment Goal: 290 
Greater than 25% of the overall study accrual will be at DF/HCC: 
 Yes   
 No 
Total DF/HCC Estimated Enrollment Goal: 290 
Adult Age Range: 60-75 
Pediatric Age Range: N/A 
Will all subjects be recruited from pediatric clinics?    
 Yes    
 No 
If enrolling both adults and pediatric subjects, anticipated percent of pediatric subjects: N/A 
Retrospective Medical Record Reviews only (Please provide date range): from       to       
 
6.  DF/HCC PARTICIPANTS UNDER DFCI IRB (check all that apply) 
 
 Beth Israel Deaconess Medical Center (BIDMC) 
 DF/BWCC in Clinical Affiliation with South Shore Hospital (DFCI @ SSH) 
 Beth Israel Deaconess Medical Center – Needham (BIDMC-Needham) 
 Dana-Farber at Milford Regional Cancer Center (DFCI @ MRCC) 
 
 Dana-Farber at Steward St. Elizabeth’s Medical Center (DFCI @ SEMC) 
 Boston Children’s Hospital (BCH) 
 Massachusetts General Hospital (MGH) 
 Brigham and Women’s Hospital (BWH) 
 Mass General/North Shore Cancer Center (MGH @ NSCC) 
 Dana-Farber Cancer Institute (DFCI) 
 Mass General at Emerson Hospital – Bethke (MGH @ EH) 
 Dana-Farber/New Hampshire Oncology-Hematology (DFCI @ NHOH) 
 New England Cancer Specialists (NECS) 
 
 
7.  NON-DF/HCC PARTICIPANTS UNDER DFCI IRB (check all that apply) 
 
 
Cape Cod Healthcare (CCH)  
 
Lowell General Hospital (LGH)  
 
New Hampshire Oncology-Hematology-P.A. (NHOH)  
 
Newton-Wellesley Hospital (NWH) 
 Broad Institute 
 Lawrence & Memorial Cancer Center in affiliation with Dana-Farber 
Community Cancer Care (LMCCC) 
 

Protocol Front Sheet 
 
FS Page: 2 
 
8.  DF/HCC INITIATED STUDIES ONLY  - INSTITUTIONAL PARTICIPANTS UNDER OTHER IRB  (N/A: 
) 
 
 
DF/HCC Multi-Center Protocols:  (list institution/location) 
 
DF/PCC Network Affiliates: (list institution/location) 
      
      
     
      
 
 

Log Sheet 
Page 1 of 1 
 
Protocol Number: 11-056 
 
Approval Date:  
04/01/11 
(IRB meeting date when protocol/consent  
 approved or conditionally approved) 
 
Activation Date:  
04/07/11 
(Date when protocol open to patient entry) 
 
Approval signatures are on file in the Office for Human Research Studies, tel. 617-632-3029. 
 
Date 
Posted 
Revised Sections 
IRB Approval 
Date 
OHRS 
Version Date 
05/31/11 
Front Sheet replaced due to Amendment #1 
05/25/11 
- 
06/06/11 
Protocol and Front Sheet replaced due to Amendment 
#2 
05/31/11 
- 
06/06/11 
Protocol replaced due to Amendment #3 
06/02/11 
- 
07/15/11 
Front Sheet replaced due to Amendment #4 
06/29/11 
- 
12/07/11 
Protocol and Front Sheet replaced due to Amendment 
#5 
12/05/11 
- 
03/08/12 
Study renewal/ Consent Form footer replaced due to 
Continuing Review #1 
02/15/12 
- 
05/29/12 
Consent Form and Front Sheet replaced due to 
Amendment #6 
05/15/12 
- 
02/14/13 
Study renewal/ Consent Form footer replaced due to 
Continuing Review #2 
02/14/13 
N/A 
08/09/13 
Correction: Front Sheet replaced due to incorrect 
version previously provided 
n/a 
n/a 
10/28/13 
Consent Form and Front Sheet replaced due to 
Amendment #7 
10/22/13 
10/23/13 
01/09/14 
Study renewal/ Consent Form footer replaced due to 
Continuing Review #3 
01/07/14 
n/a 
08/04/14 
Consent Form, Protocol and Front Sheet replaced; 
Appendix C added (as a Local Appendix) 
07/21/14 
07/23/14 
12/23/14 
Study renewal/ Consent Form footer replaced due to 
Continuing Review #4 
12/23/14 
N/A 
06/18/15 
Consent Form and Front Sheet replaced due to 
Amendment #9 
06/15/15 
06/16/15 
Date 
Posted 
Revised Sections 
IRB Approval 
Date 
OnCore 
Version Date 
12/21/15 
Study renewal/ Consent Form footer replaced due to 
Continuing Review #5 
12/21/15 
12/21/15 
Date 
Posted 
Revised Sections 
Approved 
Date  
Version Date 
(OnCore) 
12/12/16 
Study renewal/ Consent Form footer replaced due to 
Continuing Review #6 
12/02/2016 
12/05/2016 
11/29/17 
Study renewal/ Consent Form footer replaced due to 
Continuing Review #7 
11/29/2017 
11/29/2017 
05/21/2018 
Study Closed – Study Accrual Goal Met  
05/18/2018 
N/A 
10/17/2018 
Study renewal/Consent Form footer replaced per 
Continuing Review #8 
10/10/2018 
10/17/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
The Myelodysplasia Transplantation-Associated Outcomes (MDS-TAO) Study 
 
 
 
 
 
 
 
Revised July 9, 2014 
 
 
Gregory A. Abel, MD, MPH (Principal Investigator), Dana-Farber Cancer Institute 
Robert J. Soiffer, MD, Dana-Farber Cancer Institute 
Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute 
David P. Steensma, MD, MPH, Dana-Farber Cancer Institute 
Haesook T. Kim, PhD, Harvard School of Public Health 
Yi-Bin Chen, MD, Massachusetts General Hospital 
David E. Avigan, MD, Beth-Israel Deaconess Medical Center 
Areej El-Jawahri, MD, Massachusetts General Hospital 

MDS TAO 2 
TABLE OF CONTENTS 
 
1.0 ABSTRACT .............................................................................................................................. 4 
2.0 BACKGROUND AND SIGNIFICANCE ................................................................................ 4 
3.0 STUDY OBJECTIVES ............................................................................................................. 5 
3.1 Primary Objective ..................................................................................................................... 5 
3.2 Secondary Objectives................................................................................................................ 5 
4.0 STUDY POPULATION ........................................................................................................... 6 
4.1 Inclusion Criteria ...................................................................................................................... 6 
4.2 Exclusion Criteria ..................................................................................................................... 8 
5.0 STUDY DESIGN AND METHODS........................................................................................ 8 
5.1 Data Collection ......................................................................................................................... 8 
5.2 Methods of Procedure ............................................................................................................... 8 
6.0 STATISTICAL CONSIDERATIONS ..................................................................................... 9 
6.1 Study Design ............................................................................................................................. 9 
6.2 Sample Size ............................................................................................................................... 9 
6.3 Accrual ...................................................................................................................................... 9 
6.4 Primary Outcome .................................................................................................................... 10 
6.5 Interim Analyses ..................................................................................................................... 10 
6.6 Secondary Outcomes .............................................................................................................. 11 
6.7 Statistical Analysis Plan .......................................................................................................... 11 
7.0 COMMITMENT OF INSTITUTIONAL RESOURCES ....................................................... 11 
8.0 POTENTIAL CLINICAL AND POLICY IMPACT .............................................................. 12 
9.0 REFERENCES ....................................................................................................................... 13 

MDS TAO 3 
APPENDIX A: Sample of Baseline Data Abstracted in Leukemia CRIS .................................... 16 
APPENDIX B: New Patient Survey for Leukemia CRIS, including EORTC-30 ........................ 18 
APPENDIX C: Consent Form for MDS-TAO ............................................................................. 19 

MDS TAO 4 
The Myelodysplasia Transplantation-Associated Outcomes (MDS-TAO) Study 
1.0 ABSTRACT 
Although hematopoietic stem cell transplantation (HSCT) is the only therapy that can cure 
patients with the myelodysplastic syndrome (MDS), and HSCT has long been the standard of 
care for younger patients with high-risk disease, the procedure has been traditionally withheld 
from older patients due to concerns about excessive toxicity and limited underlying overall 
survival. More recently, however, HSCT with reduced-intensity conditioning (RIC) has been 
increasingly offered to older patients with the syndrome, a clinical picture that is complicated by 
the introduction of non-HSCT disease-modifying treatments for MDS such as the DNA 
methyltransferase inhibitors. We propose an observational study enrolling high-risk MDS 
patients who are fit enough to undergo RIC HSCT but whose HLA and donor status is unknown 
at baseline. Whether or not enrollees eventually go on to HSCT—indeed, many will not, due to 
factors such as lack of a suitable donor or rapid progression of disease—all will be followed for 
outcomes such as overall survival, progression free survival, and quality of life. Our protocol 
will generate much-needed comparative outcomes data for older patients with high-risk MDS, 
and has the potential to greatly influence how the disorder is treated in the United States. 
 
2.0 BACKGROUND AND SIGNIFICANCE 
The myelodysplastic syndromes (MDS) are a group of hematopoietic stem cell disorders 
characterized by ineffective hematopoiesis and a tendency to transform to leukemia. They range 
in clinical severity from incidentally-found cases manifesting with mild anemia, to highly 
symptomatic cases characterized by severe anemia, neutropenia and/or thrombocytopenia. These 
latter cases are often accompanied by hemorrhage, infection and rapid mortality, and are thus the 
focus of most MDS treatments, including HSCT. Despite recent advances in treatment and 
classification, until recently little was known about the epidemiology and patterns of care for 
patients with MDS in the United States.1 Indeed, MDS was only added to the National Cancer 
Institute’s Surveillance Epidemiology and End Results (SEER) program in 2001, and reliable 
incidence rates (2001-2003) were only recently reported: 3.4 cases per 100,000, with a male 
predominance (4.5 for males versus 2.7 for females) and three-year overall survival of 45%.2-3 
Data on patterns of care for MDS patients is also limited, although it is known that the newer 
WHO classification system4 (as compared to the older FAB system) has become widely-adopted 
in clinical pratice.5 One study reported the results of a survey among US hematologists,6 finding 
that fewer MDS patients with lower-risk disease were transfusion-dependent, a majority received 
erythropoiesis-stimulating agents (ESAs), and only a small percentage of patients had had or 
were being considered for HSCT.7  
 
This last finding is provocative, as HSCT remains the only curative option for MDS. Indeed, 
HSCT has a long and successful history in management of these hematologic disorders, using 
both ablative and RIC regimens.8-24 A recent evidence-based review published under the aegis of 
the American Society of Blood and Marrow Transplantation was supportive of the role of HSCT 
in the management of MDS.25 Moreover, the introduction of RIC regimens has greatly expanded 
the utility of HSCT in older and sicker patients by reducing the risk of regimen-related 
toxicity.26-32 For example, Kroger and associates reported on 26 patients with MDS or secondary 
AML (median age = 60; range 44 to 70) who were transplanted with RIC with cells from related 
(n=6) or unrelated (n=20) donors. Transplant-related mortality was 28%, and the two-year 

MDS TAO 5 
estimate overall survival rate was 36%.29 A Spanish trial reported results on 37 patients (median 
age = 57; range 22 to 66) with MDS or AML transplanted from HLA-identical siblings 
following a RIC regimen. The one-year transplant-related mortality and relapse-free survival 
were 5% and 66%, respectively. In our group, we have found similar outcomes in patients 
treated with RIC and myeloablative regimens. For example, we reviewed 136 patients with 
advanced AML and MDS undergoing allogeneic HSCT, comparing 39 patients receiving RIC 
HSCT to 97 patients receiving myeloablative HSCT. Patients receiving RIC were at high risk for 
treatment-related complications given that they were older, 57 vs 43 years (P < .001), and more 
likely had received previous or myeloablative transplantation (54% vs 2%; P < .0001). Still, Cox 
regression analysis showed that the intensity of the conditioning regimen had no effect on either 
overall survival or progression free survival, suggesting that RIC is a reasonable alternative for 
patients with advanced MDS or AML at high risk for complications with myeloablative HSCT.33 
 
Despite these promising preliminary results, until recently, concerns regarding morbidity and 
mortality related to even RIC HSCT limited its application in older patients (60 to 75) with 
MDS, especially given the lack of rigorous comparative outcomes data from a study including 
patients both with and without HSCT. Perhaps due to this fact, earlier this year, the Centers for 
Medicare & Medicaid Services (CMS)—the main health insurer for adults 65 and older in the 
United States—posted their controversial decision on coverage of HSCT for Medicare patients 
with MDS. In the decision, CMS disallowed coverage for HSCT, but stated that the current data 
from younger patients, especially with regard to RIC HSCT, is promising enough to provide for 
some coverage under the Coverage with Evidence Development process (§1862(a) (1) (E) of the 
Social Security Act. This allows for Medicare patients with MDS to receive HSCT provided that 
the HSCT is performed in the context of a prospective clinical study comparing Medicare 
patients with MDS who receive HSCT to similar Medicare patients with MDS who do not. In 
part to address this challenge, the aim of this current protocol is to prospectively examine post-
RIC HSCT outcomes in those patients aged 60 to 75 with MDS (which would include Medicare 
beneficiaries aged 65 to 75) to determine whether these outcomes are similar to those patients 
with MDS aged 60 to 75 who do not undergo HSCT, but who both have disease severe enough 
as well as a health status good enough they would also be eligible for RIC HSCT. 
 
3.0 STUDY OBJECTIVES 
3.1 Primary Objective 
To prospectively compare the overall survival (OS) of patients aged 60-75 who undergo HSCT 
for MDS (Group A) to that of patients aged 60-75 who do not undergo HSCT (Group B) but who 
have disease of sufficiently high enough risk to warrant HSCT and who are also fit enough to 
undergo the procedure (primary outcome). 
3.2 Secondary Objectives 
1. To prospectively compare the progression-free survival (PFS) of patients in Group A to 
that of patients in Group B as defined above (secondary outcome). 
2. To prospectively compare changes in the quality of life (QoL) from baseline to two years 
of patients in Group A to that of patients in Group B as defined above (secondary 
outcome). 

MDS TAO 6 
3. To assess the potential association of patient- and disease-specific factors—including 
International Prognostic Scoring System (IPSS) score, WHO-based Prognostic Scoring 
System (WPSS) score, number of cytopenias, transfusion dependence, disease duration at 
baseline, prior therapies and age at HSCT—with the primary and secondary outcomes. 
 
4.0 STUDY POPULATION 
Eligible patients will be 60 to 75 years old with a diagnosis of MDS or related disorder (eg, 
MDS/MPD or CMML) who have disease that is advanced enough to warrant RIC HSCT 
(defined by high-risk cytogenetics,34 int-2 or high-risk on IPSS35 or transfusion dependence as 
defined by WPSS36) and who are physically fit enough to undergo RIC HSCT as assessed by 
pre-determined measures of organ function. Patients whose baseline donor status is known will 
be excluded; however, knowledge of HLA status is allowed as long as a donor search has not 
been performed. 
4.1 Inclusion Criteria 
1. Histologically-confirmed diagnosis of: 
a. Primary or secondary MDS using the World Health Organization 
(WHO) 2008 classification:  
i. Refractory cytopenia with unilineage dysplasia 
1. Refractory Anemia (RA) 
2. Refractory Neutropenia (RN) 
3. Refractory Thromobucytopenia (RT) 
ii. Refractory Anemia with Ring Sideroblasts (RARS) 
iii. Refractory Cytopenia with Multilineage Dysplasia (RCMD) 
iv. Refractory Anemia with Excess Blasts-1 (RAEB-1) 
v. Refractory Anemia with Excess Blasts-2 (RAEB-2) 
vi. MDS with isolated del (5q) 
vii. MDS-Unclassified (MDS-U) 
 
b. Another of the following related disorders: 
i. Chronic Myelomonocytic leukemia (CMML) 
ii. Myelodysplastic/myeloproliferative neoplasm, unclassifiable 
(MDS/MPD-U) 
 
 
2.  Age 60 to 75 years 
 
 
3.  Intermediate-2 or High-Risk IPSS  
 
OR 
 
Secondary MDS (any karyotype) 
 
OR 
 
Documented non-IPSS intermediate- or poor-prognosis karyotype43 including: 
i. del(11q) 

MDS TAO 7 
ii. +8 
iii. t(11q23) 
iv. Rea 3q 
v. +19 
vi. 3 or greater abnormalities 
vii. del(7q) 
viii. -5  
ix. t(5q) 
 
 
OR 
 
Documented significant cytopenia for at least four months prior to enrollment, 
defined by the following criteria: 
 
a. Red Blood Cell (RBC) Transfusion Dependence: four or more units of 
RBC transfusions within an eight-week period for symptomatic 
anemia with hemoglobin of ≤ 9.0 g/dL; OR 
 
b. Severe Anemia: average of two or more hemoglobin values ≤ 8 g/dL 
within an eight-week period not influenced by RBC transfusions (i.e., 
must be seven days post transfusion); OR 
 
c. Severe Thrombocytopenia: average of two or more platelet counts ≤ 50 
× 109/L within an eight-week period not influenced by platelet 
transfusions (i.e., must be at least three days post- transfusion) or a 
clinically significant hemorrhage requiring platelet transfusions within 
the prior four months; OR 
 
d.  Severe Neutropenia: average of two or more absolute neutrophil 
counts (ANC) ≤ 500 within an eight-week period, or a clinically 
significant infection requiring IV antibiotics in the setting of ANC ≤ 
1000 within the prior four months. 
 
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. 
 
5. Adequate organ function to permit RIC  HSCT as indicated by the following: 
a. Serum bilirubin ≤ 2.5 mg/dL (except when Gilbert’s syndrome or 
MDS-related hemolysis suspected). 
b. AST and ALT ≤ 2.5 times the upper limit of normal (ULN). 
c. Serum creatinine ≤ 2.0 mg/dL  
d. Seemingly sufficient baseline cardiac function to undergo HSCT (no 
echocardiogram required). 
e. Seemingly sufficient baseline pulmonary function to undergo HSCT 
(no pulmonary function tests required). 
f. Seemingly sufficient neuro-psychiatric function to undergo HSCT (no 
specific neuro-psychiatric evaluation required). 

MDS TAO 8 
 
 
6. Willingness to undergo HLA-typing and consider subsequent HSCT. 
 
 
7. Willingness and ability to give informed consent. 
 
4.2 Exclusion Criteria 
 
1. Known baseline conversion to AML (eg, ≥ 20% peripheral or marrow blasts). 
 
2.  Knowledge of potential donor status at study entry. Of note, knowledge of HLA status 
WITHOUT a related or unrelated search is allowed. 
 
3. History of prior malignancy within the past year, except for adequately-treated 
carcinoma in situ of uterine cervix, basal cell or squamous cell skin cancer. 
 
4. Any severe concurrent disease, infection, or comorbidity that, in the judgment of the 
principal investigator, would make the patient inappropriate for HSCT at the time of 
study entry. 
 
5. Psychiatric disorders including dementia that would preclude obtaining informed 
consent or the ability to participate in an ongoing research study. 
 
5.0 STUDY DESIGN AND METHODS 
5.1 Data Collection 
Data for this study will be collected using the existing mechanisms of the Dana-Farber/Harvard 
Cancer Center (DF/HCC) Leukemia Clinical Research Information Systems (Leukemia CRIS) 
for baseline data (all study participants). For patients who do not go on to HSCT, Leukemia 
CRIS will be used to collect their outcomes, while HSCT patients will have outcomes collected 
in the Center for International Blood and Marrow Transplant Research Stem Cell Therapeutic 
Outcomes Database (CIBMTR SCTOD). Leukemia CRIS is a state-of-the-art information 
infrastructure for hematologic oncology at the DF/HCC, developed to link clinical outcomes to 
blood and tissue samples, and to lay the foundation for innovative pilot studies and health 
services research. The database has been accruing data since January of 2006. Patients in 
Leukemia CRIS have baseline information and a new patient survey entered at 3 months; they 
are then assessed for outcomes every 6 months for 3 years. After 3 years, their records are 
updated for outcomes once per year. Note that baseline IPSS, WPSS and entry criterion (eg, 
histology, cytogenetics, or transfusion requirements), or as well as eventual HLA status and 
donor status will be added to Leukemia CRIS data screens and captured for MDS-TAO patients. 
Also, QoL will be assessed at baseline and two years with the EORTC-30,37 a validated quality 
of life instrument, as well as the  QUALMS-1, an MDS-specific quality of life instrument being 
validated by Dr. Abel under OHRS protocol 13-346. 
 
5.2 Methods of Procedure 
A dedicated clinical research assistant will work with the hematologic oncology new patient 
coordinators at the DF/HCC member institutions (Dana-Farber Cancer Institute (DFCI), Beth 

MDS TAO 9 
Israel Deaconess Medical Center (BIDMC) and Massachusetts General Hospital (MGH)) to 
identify high-risk MDS patients that may be eligible for the study. The transplant and non-
transplant MDS physicians will be ultimately responsible for identifying patients who are 
eligible for MDS-TAO; in addition, as all MDS patients followed at the DF/HCC are eligible for 
the Leukemia CRIS database, the research assistant and the Principal Investigator will also 
perform periodic reviews of MDS patients seen at the DF/HCC to retroactively assess eligibility 
and contact the appropriate physician to encourage that physician to enroll appropriate patients. 
Of note, the point of contact for patient enrollment will always be the treating physician. 
 
Once enrolled, all study patients will be followed for the primary and secondary outcomes listed 
above, with assessments in step with those in the Leukemia CRIS system (baseline and every 6 
months for 3 years; then yearly). A difference is that MDS-TAO patients will be followed on the 
same schedule whether or not they continue to receive their care at DF/HCC (Leukemia CRIS 
does not follow patients that are only seen for one-time consultation at DF/HCC). The 
investigators understand that this will require a different informed consent, and more resources 
(eg, another clinical research assistant) to obtain and abstract outside hospital records. Also, all 
MDS-TAO enrollees will be given the EORTC-30 to take home and mail back (if they have not 
already done it as part of their Leukemia CRIS new patient survey) at baseline and again at two 
years, regardless of HSCT status or whether or not they continue to be followed at DF/HCC. All 
enrollees will also be asked to complete the QUALMS-1 instrument. Finally, as above, if any 
patient goes on to RIC HSCT, his or her data—including outcomes—will be collected in the 
CIBMTR SCTOD. 
 
6.0 STATISTICAL CONSIDERATIONS 
6.1 Study Design 
MDS-TAO is a prospective, observational study comparing OS between patients aged 60-75 
who undergo RIC HSCT for MDS (Group A) and patients 60-75 who do not undergo HSCT but 
who have disease of sufficiently high enough risk to warrant HSCT and who are also fit enough 
to undergo the procedure (Group B). 
6.2 Sample Size 
290 eligible patients will be enrolled between the two groups over a period of 5 years and 
followed for an additional 5 years. Based on our current practice, we anticipate that the 
enrollment will be 1:2 ratio for Group A (HSCT) to Group B (no HSCT). This design will give 
approximately 85% power to detect a 15% difference in 5-year OS between the two study 
groups.  
6.3 Accrual 
In 2009, the DFCI performed 18 RIC HSCTs in patients similar to the ones who will be eligible 
for the MDS-TAO study. Given the addition of the other members of the DF/HCC (BIDMC and 
MGH), we anticipate that we will accrue 20 patients per year for the HSCT group (Group A). 
There were also 50 patients seen at DFCI in 2009 with MDS of sufficiently high risk by WHO 
category (RAEB-1, RAEB-2, RCMD, and RCMD-RS) to be considered for HSCT but who did 
not ultimately receive HSCT. Thus, we project that we will accrue at least 40 patients per year 
who will enter MDS-TAO but not go on to HSCT (Group B). With 60 patients per year, we 
anticipate that accrual will be complete in 5 years.  

MDS TAO 10 
6.4 Primary Outcome 
The primary endpoint of this study is 5-year OS. OS is defined as time from study entry to death 
from any cause. Alessandro et al39 recently reported the impact of WPSS on the outcome of 
MDS patients who underwent allogeneic HSCT. According to their report, the 5-year OS after 
HSCT was 51% in RAEB-1 and 28% in RAEB2 with an indication of plateau after 5-6 years 
post transplant. This observation resembles our experience at DFCI with RIC HSCT for older 
patients with MDS. Malcovati et al36 reported that 5-year OS was 3% in the RAEB-1 group and 
14% in the RAEB-2 group among 426 MDS patients who did not undergo HSCT. Most of the 
patients in these studies, however, were treated prior to the wide use of DNA-methyltransferase 
inhibitors. Thus, extrapolating this information and based on our experience at DFCI, we 
hypothesize that a small portion of patients will be cured with HSCT from the underlying disease 
and the 5-year OS will be 25%, whereas the 5-year OS will be 10% for the non-HSCT patients 
and the survival distribution of these patients will follow an exponential distribution. In addition, 
we expect that there will be an approximately 4-6 month wait time for patients in Group A from 
enrollment to actual RIC HSCT, thus no difference in OS between the two groups is expected for 
some period after the start of the study. Based on this information and assumptions, we propose 
an alternative hypothesis as: Ha: SA>SB, where SA denotes the survival distribution of Group A 
and SB denotes the survival distribution of Group B. Specifically: 
SA =0.19+0.4*exp( t*(log2/10)) +0.41*exp(-t*(log(2)/20); and SB = exp(-t*(log(2)/18). 
The figure depicts these two survival distributions graphically. With this design, 290 patients 
will be required to achieve 85% power with one-sided significance level of 0.025. This power 
calculation is calculated using the R program Powlgrnk (developed by Dr. Robert Gray at DFCI), 
which computes power of the two-group log-rank test for arbitrary failure time distributions. 
6.5 Interim Analyses 
The study will be monitored using standard procedures and processes. Interim inspections will 
occur annually; however, as this is an observational study and no new treatment is proposed, it is 
important to note that these interim analyses will not have an effect in terms of stopping accrual 
to the study or to terminate the study early in favor of alternative or null hypothesis.  

MDS TAO 11 
6.6 Secondary Outcomes 
Secondary outcomes include PFS and changes in self-reported QoL. PFS is defined as time from 
enrollment until evidence of progression to acute leukemia (time until increase in marrow or 
peripheral blasts to >20%). QoL will be assessed via changes between baseline and two-year 
assessments on the EORTC-30 and QUALMS-1. We also plan baseline assessment of IPSS and 
WPSS, number of cytopenias, transfusion dependence, disease duration at baseline, prior 
therapies and age at HSCT. Of note, we have not based our power calculations on these 
outcomes and covariates due to their exploratory nature.  
6.7 Statistical Analysis Plan 
As a patient’s status in Group A may be changed during the study from waiting for HSCT to 
being a HSCT recipient, the effect of HSCT will be assessed in a various ways. Our first 
approach will be using the Mantel-Byer method.40 Mantel and Byer (1974) proposed a modified 
life table to avoid ‘time-to-treatment’ bias and to accommodate the transient nature of transplant 
status. The second approach is to treat patient’s transplant status as a time-dependent function, 
X=X(t), as proposed by Crowley and Hu.41 In this approach, X(t) is an indicator variable at time 
t, that is, X(t)=0 if the patient has not received the transplant at time t, and 1 if the patient has 
received the transplant at time t. Age at HSCT will be constructed in a similar manner. Another 
approach is a landmark analysis at one year after study entry.42 We will also explore a 
combination of a pointwise comparison of survival curves at specified time t and a log-rank test 
after t, using the method proposed by Logan et al.42 The last two approaches are particularly 
suitable as the overall survival between the two groups is not expected to be different during the 
first year of study, but instead start to separate after approximately one year.  
 
QoL will be assessed using the EORTC-3037and the QUALMS-1, a disease-specific measure 
developed by Dr. Abel and colleagues at DFCI which is currently undergoing validation.38 The 
predictability of IPSS or WPSS score on survival outcome will be assessed using the time-
dependent ROC curve estimation for censored survival data (survival ROC), proposed by 
Heagerty et al.44-45 The predictability of these two scoring systems will be compared in each 
group. In addition, a subset analysis will be performed for Group A (HSCT) to prospectively 
determine if disease- or patient-related factors predict outcomes of HSCT for MDS in patients 
aged 60-75. These factors include baseline age at HSCT, IPSS score, WPSS score, number of 
cytopenias, transfusion dependence, disease duration, prior therapies, and Sorror co-morbidity 
index. In this subset analysis, standard time-to-event analysis as well as competing risks data 
analysis46 will be performed. 
7.0 COMMITMENT OF INSTITUTIONAL RESOURCES 
MDS-TAO will be a long-term study, with at least 5 years of active accrual, and likely several 
more years of follow-up. The DFCI has invested a substantial commitment to the success of this 
effort. The current Leukemia CRIS program has a dedicated 100% FTE clinical research 
assistant, and is overseen by a disease-specific Principal Investigator, as well as a Population 
Scientist (2.5% FTE). MDS-TAO will call on these existing resources; in addition, the DFCI has 
committed support for another 50% FTE research assistant—who will be housed and supervised 
at the McGraw-Patterson Center for Outcomes and Policy Research—as well as 20% FTE 
programmer (to start in year 2 of the study) to assist the project biostatistician with interim 
analyses. Finally, the DFCI will fund or assist with the ascertainment of grant funding for 10% 

MDS TAO 12 
FTE of the Principal Investigator, who will work to assure the quality of the data collected as 
well as the scientific integrity of the data and any resulting manuscripts. 
8.0 POTENTIAL CLINICAL AND POLICY IMPACT 
To our knowledge, our planned analysis will be the first large study of comparative outcomes 
associated with RIC HSCT versus non-HSCT for older patients with MDS—crucial information 
for our health care system as our country becomes increasingly concerned with the costs of 
health care and comparative effectiveness. Our results will provide essential insight to patients 
and practicing oncologists regarding the advisability of HSCT for MDS patients in this largely 
understudied age group, as well as help policymakers and funding sources such as CMS 
understand if the procedures truly lead to improved outcomes. Next, the data we plan to collect 
regarding potential changes in quality of life associated with HSCT in this age group promise to 
address an important gap in the current HSCT literature. Finally, MDS-TAO would also provide 
a long-overdue source of primary and prospective data for MDS researchers as to the usefulness 
of the IPSS and WPSS in prognosticating for transplantation-related outcomes.  
 

MDS TAO 13 
9.0 REFERENCES 
 
1. 
Abel GA, Friese CR, Magazu LS, et al. Delays in referral and diagnosis for chronic 
hematologic malignancies: a literature review. Leuk Lymphoma 2008;49:1352-9. 
2. 
Rollison DE, Howlader N, Smith MT, et al. Epidemiology of myelodysplastic syndromes 
and chronic myeloproliferative disorders in the United States, 2001-2004, using data from the 
NAACCR and SEER programs. Blood 2008;112:45-52. 
3. 
Ma X, Does M, Raza A, Mayne ST. Myelodysplastic syndromes: incidence and survival 
in the United States. Cancer 2007;109:1536-42. 
4. 
Jaffe ES, Harris NL, Stein H, Vardiman JW. World Health Organization Classification of 
Tumours: Pathology and Genetics, Tumors of Haematopoietic and Lymphoid Tissues. Lyon, 
France: International Agency for Research on Cancer (IARC) Press; 2001. 
5. 
Abel GA, Van Bennekom CM, Stone RM, Anderson TE, Kaufman DW. Classification of 
the myelodysplastic syndrome in a national registry of recently diagnosed patients. Leuk Res 
2010;34:939-41. 
6. 
Sekeres MA, Schoonen WM, Kantarjian H, et al. Characteristics of US patients with 
myelodysplastic syndromes: results of six cross-sectional physician surveys. J Natl Cancer Inst 
2008;100:1542-51. 
7. 
Brez S, Rowan M, Malcolm J, et al. Transition from specialist to primary diabetes care: a 
qualitative study of perspectives of primary care physicians. BMC Fam Pract 2009;10:39. 
8. 
Laport GG, Sandmaier BM, Storer BE, et al. Reduced-intensity conditioning followed by 
allogeneic hematopoietic cell transplantation for adult patients with myelodysplastic syndrome 
and myeloproliferative disorders. Biol Blood Marrow Transplant 2008;14:246-55. 
9. 
Martino R, Valcarcel D, Brunet S, Sureda A, Sierra J. Comparable non-relapse mortality 
and survival after HLA-identical sibling blood stem cell transplantation with reduced or 
conventional-intensity preparative regimens for high-risk myelodysplasia or acute myeloid 
leukemia in first remission. Bone Marrow Transplant 2008;41:33-8. Epub 2007 Nov 5. 
10. 
Oran B, Giralt S, Saliba R, et al. Allogeneic hematopoietic stem cell transplantation for 
the treatment of high-risk acute myelogenous leukemia and myelodysplastic syndrome using 
reduced-intensity conditioning with fludarabine and melphalan. Biol Blood Marrow Transplant 
2007;13:454-62. Epub 2007 Feb 8. 
11. 
Chang C, Storer BE, Scott BL, et al. Hematopoietic cell transplantation in patients with 
myelodysplastic syndrome or acute myeloid leukemia arising from myelodysplastic syndrome: 
similar outcomes in patients with de novo disease and disease following prior therapy or 
antecedent hematologic disorders. Blood 2007;110:1379-87. Epub 2007 May 8. 
12. 
Scott BL, Sandmaier BM, Storer B, et al. Myeloablative vs nonmyeloablative allogeneic 
transplantation for patients with myelodysplastic syndrome or acute myelogenous leukemia with 
multilineage dysplasia: a retrospective analysis. Leukemia 2006;20:128-35. 
13. 
Scott B, Deeg HJ. Hemopoietic cell transplantation as curative therapy of 
myelodysplastic syndromes and myeloproliferative disorders. Best Pract Res Clin Haematol 
2006;19:519-33. 
14. 
Deeg HJ. Transplant strategies for patients with myelodysplastic syndromes. Curr Opin 
Hematol 2006;13:61-6. 
15. 
Stary J, Locatelli F, Niemeyer CM. Stem cell transplantation for aplastic anemia and 
myelodysplastic syndrome. Bone Marrow Transplant 2005;35:S13-6. 

MDS TAO 14 
16. 
Cutler CS, Lee SJ, Greenberg P, et al. A decision analysis of allogeneic bone marrow 
transplantation for the myelodysplastic syndromes: delayed transplantation for low-risk 
myelodysplasia is associated with improved outcome. Blood 2004;104:579-85. Epub 2004 Mar 
23. 
17. 
Stewart B, Verdugo M, Guthrie KA, Appelbaum F, Deeg HJ. Outcome following 
haematopoietic cell transplantation in patients with myelodysplasia and del (5q) karyotypes. Br J 
Haematol 2003;123:879-85. 
18. 
Benesch M, Deeg HJ. Hematopoietic cell transplantation for adult patients with 
myelodysplastic syndromes and myeloproliferative disorders. Mayo Clin Proc 2003;78:981-90. 
19. 
Castro-Malaspina H, Harris RE, Gajewski J, et al. Unrelated donor marrow 
transplantation for myelodysplastic syndromes: outcome analysis in 510 transplants facilitated by 
the National Marrow Donor Program. Blood 2002;99:1943-51. 
20. 
Deeg HJ, Appelbaum FR. Hemopoietic stem cell transplantation for myelodysplastic 
syndrome. Curr Opin Oncol 2000;12:116-20. 
21. 
de Witte T, Hermans J, Vossen J, et al. Haematopoietic stem cell transplantation for 
patients with myelo-dysplastic syndromes and secondary acute myeloid leukaemias: a report on 
behalf of the Chronic Leukaemia Working Party of the European Group for Blood and Marrow 
Transplantation (EBMT). Br J Haematol 2000;110:620-30. 
22. 
De Witte T. Stem cell transplantation for patients with myelodysplastic syndrome and 
secondary leukemias. Int J Hematol 2000;72:151-6. 
23. 
Lucarelli G, Clift RA, Galimberti M, et al. Bone marrow transplantation in adult 
thalassemic patients. Blood 1999;93:1164-7. 
24. 
de Witte T. Stem cell transplantation in myelodysplastic syndromes. Forum (Genova) 
1999;9:75-81. 
25. 
Oliansky DM, Antin JH, Bennett JM, et al. The role of cytotoxic therapy with 
hematopoietic stem cell transplantation in the therapy of myelodysplastic syndromes: an 
evidence-based review. Biol Blood Marrow Transplant 2009;15:137-72. 
26. 
Alyea EP, Kim HT, Ho V, et al. Impact of conditioning regimen intensity on outcome of 
allogeneic hematopoietic cell transplantation for advanced acute myelogenous leukemia and 
myelodysplastic syndrome. Biol Blood Marrow Transplant 2006;12:1047-55. 
27. 
Alyea EP, Kim HT, Ho V, et al. Comparative outcome of nonmyeloablative and 
myeloablative allogeneic hematopoietic cell transplantation for patients older than 50 years of 
age. Blood 2005;105:1810-4. Epub 2004 Sep 30. 
28. 
Alyea EP, Weller E, Fisher DC, et al. Comparable outcome with T-cell-depleted 
unrelated-donor versus related-donor allogeneic bone marrow transplantation. Biol Blood 
Marrow Transplant 2002;8:601-7. 
29. 
Kroger N, Shimoni A, Zabelina T, et al. Reduced-toxicity conditioning with treosulfan, 
fludarabine and ATG as preparative regimen for allogeneic stem cell transplantation (alloSCT) in 
elderly patients with secondary acute myeloid leukemia (sAML) or myelodysplastic syndrome 
(MDS). Bone Marrow Transplant 2006;37:339-44. 
30. 
Lim ZY, Ho AY, Ingram W, et al. Outcomes of alemtuzumab-based reduced intensity 
conditioning stem cell transplantation using unrelated donors for myelodysplastic syndromes. Br 
J Haematol 2006;135:201-9. Epub 2006 Aug 25. 
31. 
Martino R, Caballero MD, Perez-Simon JA, et al. Evidence for a graft-versus-leukemia 
effect after allogeneic peripheral blood stem cell transplantation with reduced-intensity 

MDS TAO 15 
conditioning in acute myelogenous leukemia and myelodysplastic syndromes. Blood 
2002;100:2243-5. 
32. 
van Besien K, Artz A, Smith S, et al. Fludarabine, melphalan, and alemtuzumab 
conditioning in adults with standard-risk advanced acute myeloid leukemia and myelodysplastic 
syndrome. J Clin Oncol 2005;23:5728-38. Epub 2005 Jul 11. 
33. 
Alyea EP, Kim HT, Ho V, et al. Impact of conditioning regimen intensity on outcome of 
allogeneic hematopoietic cell transplantation for advanced acute myelogenous leukemia and 
myelodysplastic syndrome. Biol Blood Marrow Transplant 2006;12:1047-55. 
34. 
Haase D, Germing U, Schanz J, et al. New insights into the prognostic impact of the 
karyotype in MDS and correlation with subtypes: evidence from a core dataset of 2124 patients. 
Blood 2007;110:4385-95. 
35. 
Greenberg P, Cox C, LeBeau MM, et al. International scoring system for evaluating 
prognosis in myelodysplastic syndromes. Blood 1997;89:2079-88. 
36. 
Malcovati L, Germing U, Kuendgen A, et al. Time-dependent prognostic scoring system 
for predicting survival and leukemic evolution in myelodysplastic syndromes. J Clin Oncol 
2007;25:3503-10. 
37. 
Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research 
and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical 
trials in oncology. J Natl Cancer Inst 1993;85:365-76. 
38. Abel G, Lee SJ, Stone R, et al. Development of a disease-specific measure of quality of life 
in myelodysplastic syndromes (MDS): the “QUALMS-1” [abstract]. J Clin Oncol 
2012;30(suppl; abstr 6103):407s. 
39. 
Alessandrino EP, Della Porta MG, Bacigalupo A, et al. WHO classification and WPSS 
predict posttransplantation outcome in patients with myelodysplastic syndrome: a study from the 
Gruppo Italiano Trapianto di Midollo Osseo (GITMO). Blood 2008;112:895-902. 
40. 
Mantel N, Byar D. Evaluation of Response-Time Data Involving Transient States: An 
Illustration Using Heart-Transplant Data. Journal of the American Statistical Association 
1974;68:81-6. 
41. 
Crowley JH, Marie. Covariance Analysis of Heart Transplant Survival Data. Journal of 
the American Statistical Association 1977;72:27-36. 
42. 
Anderson JR, Cain KC, Gelber RD. Analysis of survival by tumor response. J Clin Oncol 
1983;1:710-9. 
43. 
Logan BR, Klein JP, Zhang MJ. Comparing treatments in the presence of crossing 
survival curves: an application to bone marrow transplantation. Biometrics 2008;64:733-40. 
Epub 2008 Jan 11. 
44. 
Heagerty PJ, Lumley T, Pepe MS. Time-dependent ROC curves for censored survival 
data and a diagnostic marker. Biometrics 2000;56:337-44. 
45. 
Pencina MJ, D'Agostino RB, Sr., D'Agostino RB, Jr., Vasan RS. Evaluating the added 
predictive ability of a new marker: from area under the ROC curve to reclassification and 
beyond. Stat Med 2008;27:157-72; discussion 207-12. 
46. 
Kim HT. Cumulative incidence in competing risks data and competing risks regression 
analysis. Clin Cancer Res 2007;13:559-65. 
 

MDS TAO 16 
APPENDIX A: Sample of Baseline Data Abstracted in Leukemia CRIS 
 
1. 
Data from the New Patient Survey 
Reason for Seeking Care 
Other Therapies 
 
Quality of Life 
Medical Hx 
 
Demographics  
Pt Status 
Cancer Hx 
Tobacco Hx 
Social History  
Household Members  
Family Hx 
 
 
2. 
 Data abstracted from Medical Record 
Demographics 
Patient Disease and morphology 
Episode 
Diagnosis Detail 
Pt Status 
 
Sites of Involvement  
Lab Results and tests  
BCR-ABL:  
FLT-3 AL (D835 mutation) 
FLT-3 ITD 
Hematocrit 
JAK-2  
Malignant Cells in Blood 
Malignant Cells in BM aspirate  
Malignant Cells in BM Biopsy 
NPM-1:  
Platelet Count 
RAR-Alpha 
White Blood Cell Count  
Cytogenetics 
t (1;19)   
t (4;11)   
t (6;9)  
t (8;14)   
t (8;21)   
t (9;11)   
t (9;22)   
t (11;14)   
t (14;18)   
t (15;17 

MDS TAO 17 
t (16;16) 
Hyperdiploid 
abn 3q: 
abn 13q 
 
abn 17p 
abn 21q 
del 5q: 
monosomy 5 
del 7q/monosomy 7 
del 9q 
del 11q 
del 12p 
del 17 p 
del 20q 
inv 16 
trisomy 6 
trisomy 8 
trisomy 12 
trisomy 21 
trisomy 22 
Normal karyotype 
Other: other cytogenetic events not listed above 
Other abnormalities: other chromosomal abnormalities not listed 
Multiple complex abnormalities: 
Not Performed  
Inconclusive Results 
Hospitalizations 
Treatments 

MDS TAO 18 
APPENDIX B: New Patient Survey for Leukemia CRIS, including EORTC-30 

MDS TAO 19 
APPENDIX C: QUALMS-1 Quality of Life Instrument

MDS TAO 20 
APPENDIX D: Consent Form for MDS-TAO 

             He m at olo gic O nc ol o g y Ne w P atie nt S ur ve y     
 
© Da na- Far ber/ Part ners Ca ncer Care    1 2/ 1 9/ 0 7                        
Pa ge 1 of 1 2  
 
 
                        
 
P atie nt N a me                
A ge         
D. O. B.    
 
D F CI M R N         
 
B W H M R N  
M G H M R N  
 
 
A p pt Pr o vi der  
A p pt D ate/ Ti me   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
R E A S O N F O R S E E KI N G C A R E  
 
W here were y o u first di a g n ose d wit h y o ur bl o o d dis or der ?  
 
Select  O N E. O  E mer ge nc y R o o m 
 
 
 
O  H os pital 
O  He mat ol o gist/ O nc ol o gist’s office 
O  Pri mar y Care P h ysicia n 
 
 
 
O  Ot her p h ysicia n office 
 
 
 
O  Ot her 
 
H a ve y o u see n a n ot her p h ysici a n  f or y o ur c urre nt bl o o d dis or der ? 
 
 
 
 
O  N o   O  Yes   
 
 
 
 
If yes, w h at t y pe of p h ysici a n(s) h a ve y o u see n pre vi o usl y f or t he tre at me nt or e v al u ati o n  
of y o ur c urre nt bl o o d dis or der ?   
 
Select A L L  t hat a p pl y. 
 Me dical o nc ol o gist (treats wit h c he m ot hera p y / me dici nes) 
 
 Pri mar y care p h ysicia n   
 Ra diati o n o nc ol o gist (treats wit h ra diati o n) 
 Ot her ( Please s pecif y: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _) 
 
 
Please fill o ut t his f or m  a n d ret ur n it t o t he  
M AI N R E C E P TI O N D E S K  
 
Please c o m plete t his f or m as t h or o u g h l y as p ossi ble.  T his i nf or mati o n 
will hel p y o ur healt h care pr o vi ders t o de vel o p a pl a n of care tail ore d t o 
y o ur nee ds.   
 
T ha n k y o u.  
 
M D S- T A O A p pe n di x B 

 
© Da na- Far ber/ Part ners Ca ncer Care    1/ 1 2/ 2 0 0 9                        
Pa ge 2 of 1 2   
R E A S O N F O R S E E KI N G C A R E (c o nti n ue d)  
 
H a ve y o u recei ve d a n y pri or tre at me nts f or y o ur bl o o d dis or der ? 
 
  
O  N o   O  Yes   
 
If yes, w h at pri or tre at me nts h a ve y o u recei ve d ? 
 
Select A L L  t hat a p pl y. 
 C he m ot hera p y 
 Ra diati o n t hera p y 
 S ur ger y 
 Vacci ne t hera p y 
 Ot her ( Please s pecif y: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _) 
 
W h o rec o m me n de d t h at y o u t o c o me t o D F CI/ M G H f or c o ns ult ati o n ?    
 
Select A L L  t hat a p pl y. 
 C hil dre n 
 Frie n d 
 I nter net 
 M y o nc ol o gist 
 M y pri mar y care p h ysicia n 
 Self 
 S p o use 
 Ot her fa mil y 
 Ot her ( Please s pecif y: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _) 
 
W h y are y o u c o mi n g t o cli nic t o d a y ?   
 
Select A L L  t hat a p pl y. 
 T o fi n d o ut w het her I ha ve a bl o o d dis or der 
 
 T o see if I’ m eli gi ble f or a cli nical trial 
 
 T o fi n d o ut if t here are a n y ne w treat me nts a vaila ble 
 Ot her ( Please s pecif y: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _) 
 
D o y o u e x pect t o recei ve y o u r o n g oi n g c are at D F CI/ M G H ? 
Select  O N E.    
 
O  N o- I’ m here f or a sec o n d o pi ni o n 
O  Yes 
O  N ot s ure 

 
©Dana-Farber/Partners Cancer Care    1/12/2009                       
Page 3 of 12  
REASON FOR SEEKING CARE (continued) 
 
Outside of a multivitamin do you REGULARLY do other  
 
 
 
 
complementary/nontraditional/alternative therapies? 
 
O No   O Yes   
 
 
If yes, which therapies? 
Select ALL that apply. 
 
 
 
 
 
 
 
 
 
 
 
QUALITY OF LIFE 
 
We are interested in some things about you and your health.  Please answer all of the questions by 
circling the number that applies to you.  
 
 
Not at     
All 
A 
Little 
Quite 
a Bit 
Very 
Much 
Do you have any trouble doing strenuous activities, like carrying a 
heavy shopping bag or a suitcase? 
   1 
    2 
   3 
   4 
Do you have any trouble taking a long walk? 
   1 
    2 
   3 
   4 
Do you have any trouble taking a short walk? 
   1 
    2 
   3 
   4 
Do you need to stay in bed or a chair during the day? 
   1 
    2 
   3 
   4 
Do you need help with eating, dressing, washing yourself or using the 
toilet? 
   1 
    2 
   3 
   4 
 
 Acupressure  
 
 
 Macrobiotics  
 
 Tai Chi or Chi Gong 
 Acupuncture  
 
 
 Massage 
 
 
 Yoga 
 Biofeedback  
 
 
 Meditation  
 
 Other (please specify 
 Body Work  
 
 
 Megavitamins 
 
     ________________)  
 Herbal and botanical remedies 
 Reiki 
 Hypnosis 
 
 
 
 Spiritual healing 
 

 
©Dana-Farber/Partners Cancer Care    1/12/2009                       
Page 4 of 12  
QUALITY OF LIFE (continued) 
 
During the past week: 
Not at     
All 
A 
Little 
Quite 
a Bit 
Very 
Much 
Were you limited in doing either your work or other daily activities? 
   1 
    2 
   3 
   4 
Were you limited in pursuing your hobbies or other leisure time 
activities? 
   1 
    2 
   3 
   4 
Were you short of breath? 
   1 
    2 
   3 
   4 
Have you had pain? 
   1 
    2 
   3 
   4 
Did you need to rest? 
   1 
    2 
   3 
   4 
Have you had trouble sleeping? 
   1 
    2 
   3 
   4 
Have you felt weak? 
   1 
    2 
   3 
   4 
Have you lacked appetite? 
   1 
    2 
   3 
   4 
Have you felt nauseated? 
   1 
    2 
   3 
   4 
Have you vomited? 
   1 
    2 
   3 
   4 
Have you been constipated? 
   1 
    2 
   3 
   4 
Have you had diarrhea? 
   1 
    2 
   3 
   4 
Were you tired? 
   1 
    2 
   3 
   4 
Did pain interfere with your daily activities? 
   1 
    2 
   3 
   4 
Have you had difficulty in concentrating on things, like reading a 
newspaper or watching television? 
   1 
    2 
   3 
   4 
Did you feel tense? 
   1 
    2 
   3 
   4 
Did you worry? 
   1 
    2 
   3 
   4 
Did you feel irritable? 
   1 
    2 
   3 
   4 
Did you feel depressed? 
   1 
    2 
   3 
   4 
Have you had difficulty remembering things? 
   1 
    2 
   3 
   4 
Has your physical condition or medical treatment interfered with your 
family life? 
   1 
    2 
   3 
   4 
Has your physical condition or medical treatment interfered with your 
social activities? 
   1 
    2 
   3 
   4 
Has your physical condition or medical treatment caused you financial 
difficulties? 
   1 
    2 
   3 
   4 
 
For the following questions please circle the number between 1 and 7 that best applies to you. 
 
How would you rate your overall health during the past week? 
         
           1            2        3         4         5       6         7 
    Very poor                                                    Excellent    
 
How would you rate your overall quality of life during the past week? 
 
           1            2        3         4         5       6         7 
    Very poor                                                    Excellent  
                                                      

 
©Dana-Farber/Partners Cancer Care    1/12/2009                       
Page 5 of 12  
QUALITY OF LIFE (continued) 
 
Which option below describes your level of physical activity OVER THE PAST WEEK?   
 
Select ONE 
O Fully active, able to carry on all usual activities without restriction 
O Restricted in strenuous activity; can walk; able to carry out light housework 
O Can walk and care for self; up more than ½ day 
O Need some help taking care of self; spend more than ½ day in bed or chair 
O Cannot take care of self at all and spend all of my time in bed or chair 
 
MEDICAL HISTORY 
 
Have you ever had a heart attack? 
O No      O Yes 
 
Have you ever been treated for heart failure (you may have been short of breath  
 
and the doctor may have told you that you had fluid in your lungs or that your  
 
heart was not pumping well)? 
O No      O Yes 
 
Have you ever had an operation to unclog or bypass the arteries in your legs? 
O No      O Yes 
 
Have you had a stroke, cerebrovascular accident, blood clot or bleeding in the brain,  
 
or transient ischemic attack (TIA)? 
O No      O Yes 
 
If yes, do you have difficulty moving an arm or leg as a result of a stroke or  
 
cerebrovascular accident? 
O No      O Yes 
 
Do you have asthma, emphysema, chronic bronchitis, or chronic obstructive  
lung disease? 
O No      O Yes 
 
 If yes, do you take medicine for your condition (either on a regular basis or just 
for flare-ups)? 
 
O No      O Yes 
 
Do you have stomach ulcers or peptic ulcer disease? 
 
O No      O Yes 
 
 If yes, was this condition diagnosed by endoscopy (where a doctor looks  
into your stomach through a scope) or an upper GI or barium swallow study  
(where you swallow chalky dye and then x-rays are taken)? 
 
O No      O Yes 
 
Do you have diabetes or high blood sugar? 
 
O No      O Yes 
 If yes, answer all of the following four questions: 
is it treated by modifying your diet? 
 
O No      O Yes 
is it treated by medications taken by mouth? 
 
O No      O Yes 
is it treated by insulin injections? 
 
O No      O Yes 
has your diabetes caused problems with your kidneys or  
problems with your eyes (treated by an opthalmologist)? 
 
O No      O Yes 

 
©Dana-Farber/Partners Cancer Care    1/12/2009                       
Page 6 of 12  
MEDICAL HISTORY (continued) 
 
Have you ever had problems with your kidneys? 
O No      O Yes 
    
 
If yes, have you had poor kidney function with blood tests showing:  
 
 
high creatinine levels? 
O No      O Yes 
 have you used hemodialysis or peritoneal dialysis? 
O No      O Yes 
 have you received a kidney transplant? 
O No      O Yes 
__________________________________________________________________________________________ 
Do you have rheumatoid arthritis? 
O No      O Yes 
 
If yes, do you take medications for it regularly? 
O No      O Yes 
 
Do you have lupus (systemic lupus erythematosus) or polymyalgia rheumatica? 
O No      O Yes 
 
Do you have any of the following conditions? 
 
 
 
Alzheimer’s Disease or another form of dementia? 
 
O No      O Yes 
 
Cirrhosis or serious liver damage? 
 
O No      O Yes 
 
AIDS? (This question is optional.) 
 
O No      O Yes 
 
Leukemia or polycythemia vera? 
 
O No      O Yes 
 
Lymphoma? 
 
O No      O Yes 
 
Cancer (other than skin cancer, leukemia or lymphoma)? 
 
O No      O Yes 
If yes, has the cancer spread or metastasized to other parts of your body?  
O No      O Yes 
_____________________________________________________________________________ 
Have you received a heart, lung, liver or pancreas transplant?    
O No      O Yes 
__________________________________________________________________________________________ 
Do you have any other autoimmune disease (besides lupus or polymyalgia rheumatica)?   
If so, what kind?______________________ 
O No      O Yes 
_______________________________________________________________________________________ 
Do you have a history of immunodeficiency? 
 
O No      O Yes 
If yes, please elaborate____________________________________ 
__________________________________________________________________________________________ 
Have you ever tested positive for HIV? (This question is optional) 
 
O No      O Yes 
 
If yes, have you ever received antiviral treatment?  
 
 
      
      O No      O Yes  
__________________________________________________________________________________________ 
Have you ever tested positive for hepatitis B? 
 
O No      O Yes 
 
If yes, have you ever received treatment? 
 
 
 
 
      
      O No      O Yes  
__________________________________________________________________________________________ 
Have you ever tested positive for hepatitis C? 
 
O No      O Yes 
 
If yes, have you ever received treatment? 
 
 
 
 
      
      O No      O Yes  
__________________________________________________________________________________________ 
Were you told that you have Heliobacter pylori (either during an endoscopy  
O No      O Yes 
or by blood test)? 
__________________________________________________________________________________________ 
Do you have either Crohn’s disease or ulcerative colitis? 
 
O No      O Yes 
__________________________________________________________________________________________ 
Do you have celiac sprue? 
 
O No      O Yes 
_____________________________________________________________________________

 
©Dana-Farber/Partners Cancer Care    1/12/2009                       
Page 7 of 12  
PATIENT BACKGROUND INFORMATION 
For research purposes only, we would like to know the following information. 
Are you of Spanish / Hispanic origin? 
 
 
 
O No 
 
 
 
O Yes  
 
 
 
O Not sure 
 
What best describes your racial background?  Select ALL that apply. 
 
       Definitions from Federal Government's Office of Management and Budget 
 
 
American Indian or 
Alaskan Native 
Have origins in any of the original peoples of North and South America 
(including Central America) and maintain tribal affiliation or 
community attachment 
 
Asian 
Have origins in any of the original peoples of the Far East, Southeast 
Asia, or the Indian subcontinent including for example, Cambodia, 
China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, 
Thailand and Vietnam 
 
Black or African American Have origins in any of the original peoples of Africa: includes Haitian 
 
 
Native Hawaiian or Other 
Pacific Islander 
Have origins in any of the original peoples of Hawaii, Guam, Samoa, or 
other Pacific Island 
 
White 
Have origins in any of the original peoples of Europe, the Middle East 
or North Africa 
 
What best describes your educational status?  
 
Select ONE 
O Some grade school  
 
 
O Some college or associate’s degree 
O Some high school  
 
 
O College 
 
O High school graduate 
 
 
O Graduate or professional school 
O Vocational or technical school  
 
O Other (Please specify __________)  
beyond high school 
 
 
What is your current employment status?  
 
Select ONE 
O  Disabled 
O Part time student   
 
O  Employed 32 hours or more per week 
O Part time student and also employed  
 
 
O  Employed less than 32 hours per week 
 less than 32 hours per week 
 
O  Full time student 
O Retired 
 
O Homemaker 
O Unemployed and/or seeking work   
 
O On medical leave  
O Other (Please specify __________) 
 
 
  

 
© Da na- Far ber/ Part ners Ca ncer Care    1/ 1 2/ 2 0 0 9                        
Pa ge 8 of 1 2   
P A TI E N T B A C K G R O U N D I N F O R M A TI O N(c o nti n ue d)  
 
W h at is y o ur c urre nt wei g ht ?  
  
            p o u n ds 
 
W h at w as y o ur wei g ht 6 m o nt hs a g o ?    
  
p o u n ds 
 
 
W h at is y o ur c urre nt hei g ht ?   
  
        feet                      i nc hes 
 
P A S T C A N C E R HI S T O R Y  
 
I n t he p ast, h a ve y o u e ver h a d a n y of t he f oll o win g t y pes of c a ncer liste d bel o w ?   C hec k A L L  t h at a p pl y 
( d o n ot i ncl u de b as al cell s ki n c a ncer). 
 
 
 
 
 
F or e ac h of t he c a ncers c hec ke d, w h at t y pe of  tre at me nt di d y o u recei ve f or it ?  C hec k A L L t h at a p pl y.  
 
C a n c er di a g n o si s 
A p pr o xi m ate 
di a g n osis d ate 
C he m ot her a p y  S ur ger y  
R a di ati o n 
T her a p y 
H or m o ne 
T her a p y 
  Bla d der 
 
   
 
 
 
  Brai n 
 
   
 
 
 
  Breast 
 
 
 
 
 
  C ol o n 
 
 
 
 
 
  C ol orectal 
 
 
 
 
 
  H o d g ki n’s l y m p h o ma 
 
 
 
 
 
  I n vasi ve cer vical 
 
 
 
 
 
 Ki d ne y 
 
   
 
 
 
  Le u ke mia 
 
 
 
 
 
  Li ver 
 
   
 
 
 
  L u n g 
 
   
 
 
 
  L y m p h o ma, t y pe u n k n o w n 
 
   
 
 
 
  Mela n o ma 
 
   
 
 
 
  M o ut h/t hr oat 
 
   
 
 
 
  M ulti ple M yel o ma 
 
   
 
 
 
  N o n- h o d g ki n’s l y m p h o ma 
 
   
 
 
 
  O varia n 
 
   
 
 
 
  Pa ncreatic 
 
   
 
 
 
  Pr ostate 
 
 
 
 
 
  Rectal 
 
   
 
 
 
  St o mac h 
 
   
 
 
 
  T h yr oi d 
 
   
 
 
 
  Uteri ne/ E n d o metrial 
 
 
 
 
 
 Ot her ( Please S pecif y _ _ _ _ _ _ _) 
 
 
 
 
 
 
 

 
©Dana-Farber/Partners Cancer Care    1/12/2009                       
Page 9 of 12  
TOBACCO HISTORY 
 
Have you ever smoked more than 100 cigarettes in your lifetime?  
O No      O Yes 
 
If Yes…  
How old were you when you started smoking cigarettes?  
 
  Age started 
 
Throughout the time that you smoked cigarettes, what is  
the average number of cigarettes per day that you smoked?  
 Number cigarettes per day 
 
Do you currently smoke cigarettes (within the past month)?  
O No      O Yes 
 
If No…  
What was the date that you stopped smoking cigarettes? 
 /
 /
  
 
SOCIAL HISTORY 
 
Have you ever or do you currently drink alcohol? 
 
Select ONE  O No, never 
O Yes, but only in the past  
O Yes, currently 
 
How many alcoholic beverages (beer, wine, mixed drinks, etc) do you consume weekly?  
 
 
Select ONE  O None 
O 5-9 drinks per week 
 
O Less than 1 drink per week  
O 10-19 drinks per week 
 
O 1- 4 drinks per week 
 
O More than 19 drinks per week 
 
 
 
 
If your alcohol intake in the past was different from now, how many alcoholic beverages (beer, wine, 
mixed drinks, etc) did you consume weekly? 
 
 
Select ONE  O None 
O 5-9 drinks per week 
 
O Less than 1 drink per week  
O 10-19 drinks per week 
 
 
O 1- 4 drinks per week                        O More than 19 drinks per week  
 

 
©Dana-Farber/Partners Cancer Care    1/12/2009                       
Page 10 of 12  
HOUSEHOLD MEMBERS 
Please list the age of all the people who live with you and their relationship to you.  Please include all people 
who share your household, whether they are blood relatives or not (see key below).  If there is more than one 
person with a particular relationship to you, please assign each a number (e.g. Son 1   Son 2). 
 
 
No household members 
 
 
 
 
 
 
 
 
 
FAMILY HISTORY 
 
Please include only blood relatives, both living and deceased. 
How many sisters do you have? 
 
How many brothers? 
 
 
 
How many daughters? 
 
 
 
How many sons? 
 
 
 
 
 
Household Member 
Age 
 
 
 
 
 
 
 
 
Key: 
 
Household Members 
Aunt   
Grandson 
            Personal Care Assistant 
Brother  
Housekeeping Staff 
Roommate 
Cousin  
Husband 
 
Significant Other 
Daughter 
Mother  
 
Sister 
Father  
Nanny  
 
Son 
Granddaughter Nephew 
 
Tenant 
Grandfather 
Niece  
 
Uncle 
Grandmother 
Nurse  
 
Wife 
Other (Please Specify ________________________) 

 
© Da na- Far ber/ Part ners Ca ncer Care    1/ 1 2/ 2 0 0 9                        
Pa ge 1 1 of 1 2   
F A MI L Y HI S T O R Y (c o nti n ue d)  
 
D o y o u h a ve a n y bl o o d rel ate d rel ati ves w h o h a ve bee n di a g n ose d wit h c a ncer ?  If yes, please use t he c hart 
bel o w t o i n dicate t heir relati o ns hi p t o  y o u, t he t y pe of ca ncer t he y ha ve, t heir a ge at dia g n osis, a n d w het her or 
n ot t he y are still li vi n g.    
   
 
N O T E : If y o u ha ve m or e t ha n o ne relative of a partic ular t y pe w h o has b ee n dia g n ose d wit h ca ncer, please 
assi g n eac h a n u m ber i n t he relati ve c o l u m n.  E. g. Sister 1 a n d Sister 2 
 
* F or e xa m ple if y o ur m ot her was di a g n ose d wit h st o mac h ca ncer at a ge 6 3 a n d s he is still li vi n g, y o u w o ul d 
pri nt M ot her i n t he Relati ve c ol u m n, St o mac h i n t he Ca ncer T y pe c ol u m n, 6 3 i n t he A ge at Dia g n osis c ol u m n 
a n d c hec k off Yes i n t he Ali ve c ol u m n.  If y o u o nl y k n o w t hat s he was dia g n ose d s o meti me i n her 6 0’s, y o u 
w o ul d pri nt 6 0 i n t he A ge at Dia g n osis c ol u m n a n d c hec k off Yes i n t he A ge Esti mate d t o t he Deca de 
C ol u m n.  
 
Bl o o d Rel ati ve 
 
M ater n al/ 
P ater n al/ B ot h 
       C a ncer T y pe  
   A ge at  
Di a g n osis 
Is A ge Esti m ate d
  t o t he dec a de ? 
                   Ali ve ? 
S a m ple 
           M ot her 
     M  
St o m ac h C a ncer     6 3 
       Yes 
 Yes    N o    N ot S ure
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
         * Rel ati ves 
    
                             * * C a ncer T y pes  
   A u nt  
  M ot her  
 
Bla d der 
Le u ke mia 
Pa ncreatic   
 
   Br ot her  
  Sister  
 
Brai n 
Li ver   
Pr ostate 
   C o usi n  
  S o n  
  
Breast 
L u n g                 
Rectal        
   Da u g hter  
  U ncle  
                   C ol o n 
L y m p h o ma, t y pe u n k n o w n     St o mac h   
   Fat her  
  Ot her ( Please                  C ol orectal 
Mela n o ma 
T h yr oi d 
   Gra n dfat her    s pecif y _ _ _ _ _ _ _)               H o d g ki n’s l y m p h o ma  M o ut h/t hr oat                        Uteri ne/ E n d o metrial            
   Gra n d m ot her      
  
I n vasi ve Cer vical           M ulti ple M yel o ma                  U n k n o w n    
 
    
    
  
Ki d ne y 
N o n- H o d g ki n’s L y m p h o ma  Ot her ( Please  
            
  
               
 
O varia n    
s pecif y _ _ _ _ _ _ _) 
  
               
 

 
©Dana-Farber/Partners Cancer Care    1/12/2009                       
Page 12 of 12  
In order to facilitate correspondence with you and your physicians please confirm the following information and 
correct if necessary. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient: 
 
Name: 
  
 
Name:  
 
 
 
 
 
 
 
  
Address: 
  
 
Address:  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
Home Phone: (           )   
 
Home Phone:  (_____)  
 
 
 
 
 
Work Phone:  (           )  
 
Work Phone:  (_____)  
 
 
 
 
 
Marital Status:   
 
 
Marital Status:    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Referring physician:                                               
 
Name:  
  
 
Name:  
 
 
 
 
 
 
 
  
Address: 
  
 
Address:  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
Phone:  
 (           )  
 
Phone: 
(_____) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Primary Care physician:                                                
 
Name:  
  
 
Name:  
 
 
 
 
 
 
 
  
Address: 
  
 
Address:  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
Phone:  
 (           )  
 
Phone: 
(_____) 
 
 
 
 
 

Q.U.A.L.M.S.-1© Dana-Farber Cancer Institute, Boston, MA 
The Quality of Life in Myelodysplasia Scale 
 
Patients often have different experiences over the course of their illness; however, please limit your responses to 
your experience over the past week only. The information you provide will remain strictly confidential. 
 
  
 
During the past week, how often… 
Never 
Rarely 
Sometimes Often
Always
1 
…did you feel as though there was a lack of clear 
information about your disease? 
 
 
 
 
 
2 
…have you felt there was limited emotional support 
available for patients with MDS beyond their 
families? 
 
 
 
 
 
3 
…did you feel as though you couldn’t do anything 
about your disease? 
 
 
 
 
 
4 
…did you feel the course of your disease was 
unpredictable? 
 
 
 
 
 
5 
…did you have difficulty explaining MDS to your 
friends or family? 
 
 
 
 
 
6 
…did you have trouble concentrating? 
 
 
 
 
 
7 
…have you considered changing long-term plans     
due to health concerns? 
 
 
 
 
 
8 
…have you experienced shortness of breath? 
 
 
 
 
 
9 
…did low energy levels cause you to change your 
schedule? 
 
 
 
 
 
10 …did you feel as though your life was organized 
around medical appointments? 
 
 
 
 
 
11 …have you felt a sense of hopelessness? 
 
 
 
 
 
12 …have you been worried about getting an infection? 
 
 
 
 
 
13 …have you had sufficient energy for routine tasks? 
 
 
 
 
 
14 …were you afraid of dying? 
 
 
 
 
 
15 …did you feel angry about your diagnosis? 
 
 
 
 
 
16 …were you worried about bleeding? 
 
 
 
 
 
17 …did you feel a sense of gratitude for a part of life 
that you took for granted before? 
 
 
 
 
 
18 …did you feel nauseated? 
 
 
 
 
 
19 …did you worry about your MDS progressing or 
developing into leukemia? 
 
 
 
 
 
20 …did you take into account that you might be 
fatigued when planning your activities? 
 
 
 
 
 
Please continue on 
to the next page  
Version 2.May 2013 

F or t he f oll o wi n g q uesti o ns, please a gai n mar k t he a ns wer  c h oice t hat best re prese nts y o ur e x perie nces a n d 
feeli n gs o ver t he p ast wee k . T he i nf or mati o n y o u pr o vi de will re mai n strictl y c o nfi de ntial. 
 
 
 
F or t he f oll o wi n g q uesti o ns, y o u m a y select “ n ot a p plic a ble ”  if t he q uesti o n d oes n ot a p pl y t o y o u.  
 
 
  
D uri n g t he p ast wee k, h o w ofte n … 
Ne ver  
R arel y  
S o meti mes  Ofte n  
Al w a ys
2 1 
… were y o u c o ncer ne d t hat y o ur M D S ca use d a 
fi na ncial b ur de n f or y o u or y o ur fa mil y? 
 
 
 
 
 
2 2 
… di d y o u feel y o ur fa mil y relati o ns hi ps were 
strai ne d b y y o ur disease? 
 
 
 
 
 
2 3  … ha ve y o u felt wea k? 
 
 
 
 
 
2 4 
… ha ve y o u bee n t o o tire d t o ta ke o n t he 
res p o nsi bilities y o u use d t o ha ve? 
 
 
 
 
 
2 5 
… di d y o u w orr y a b o ut bec o mi n g a b ur de n t o y o ur 
frie n ds or fa mil y? 
 
 
 
 
 
2 6 
… were y o u u na ble t o partici p ate i n acti vities y o u are 
use d t o d oi n g? 
 
 
 
 
 
2 7  … ha ve y o u felt a n xi o us a b o ut test or la b res ults? 
 
 
 
 
 
2 8 
… di d y o u a v oi d cr o w ds beca use of fear of getti n g a n 
i nfecti o n? 
 
 
 
 
 
2 9  … di d y o u fi n d y o urself gr atef ul f or t o m orr o w? 
 
 
 
 
 
3 0 
… di d y o u feel y o u were a ble t o fi n d q ualit y 
i nf or mati o n a b o ut M D S treat me nts? 
 
 
 
 
 
3 1  … were y o u c o ncer ne d a b o ut br uisi n g? 
 
 
 
 
 
3 2 
… di d y o u feel as t h o u g h t here we re a lac k of c o ncrete 
a ns wers a b o ut w hat will ha p pe n wit h y o ur M D S? 
 
 
 
 
 
3 3  … di d y o u e x perie nce a c ha n ge i n b o wel ha bits? 
 
 
 
 
 
  
D uri n g t he p ast wee k, h o w ofte n … 
Ne ver  
R arel y  
S o meti mes  Ofte n  
Al w a ys
3 4 
… were y o u afrai d of l osi n g y o ur j o b? ( c hec k here  
if n ot a p plica ble beca use y o u are u ne m pl o ye d/retire d) 
 
 
 
 
 
3 5 
… di d y o u feel t o o tire d t o dri ve? ( c hec k here  if n ot 
a p plica ble beca use y o u d o n ot dri ve) 
 
 
 
 
 
3 6 
… were y o u afrai d t o ha ve se x d ue t o y o ur bl o o d 
c o u nts? ( c hec k here  if n ot a p plica ble beca use y o u 
are n ot c urre ntl y se x uall y acti ve) 
 
 
 
 
 
3 7 
… were y o u afrai d t hat y o ur M D S treat me nt w o ul d 
st o p w or ki n g? (c hec k here  if n ot a p plica ble 
beca use y o u are n ot c urre ntl y bei n g treate d) 
 
 
 
 
 
3 8 
… ha ve y o u bee n t o o tire d t o ta ke care of a fa mil y 
me m ber or l o ve d o ne? ( c hec k here  if n ot 
a p plica ble beca use y o u are n ot pr o vi di n g s uc h care) 
 
 
 
 
 
T h a n k y o u f or c o m pleti n g 
t he Q U A L M S- 1.
V er si o n 2. M a y 2 0 1 3