Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation
Phase: NA
Conditions: Other Cancer
Sponsor: Dana-Farber Cancer Institute

Version 8  11/16/2020 
Shared Care: Patient-Centered Management after 
Hematopoietic Cell Transplantation
Gregory A. Abel, Joseph Antin, Vincent Ho, Brett Glotzbecker, and Haesook Kim
Division of Hematologic Oncology and Division of Population Sciences
Department of Medical Oncology
Dana-Farber Cancer Institute

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Protocol Schema
Study Complete
Identify, Screen, & Recruit Participants
Patients informed of trial at DFCI during first consultation with HCT physician and RN (first HCT 
consult is when the patients receive HCT information book).
After donor search, eligible allogeneic HCT patients (those who live near Shared care site) 
identified. 
Willing patients are consented for study at their transplant consent session.
Randomization
Consenting patients randomized into one of two study arms.
Data Collection
Patient-Reported Outcomes (PROs) collected 100 days and 180 days post-transplant and as 
determined by the modified Delphi (protocol 17-088); collection is done at DFCI for patients in 
both arms.
Non-relapse mortality (NRM) assessed at 100 days.
Collection of all emergency department visits and hospitalizations, locally and at DFCI.
Shared Care ends at day 180.
Myeloablative or Mod Intensity (Flu/Mel) 
Allogeneic Transplant
Patients remain in hospital for approximately 
30 days; first day of study (Shared versus 
Usual Care) is day of inpatient discharge.
Reduced Intensity (RIC) Transplant
RIC patients discharged approximately 1-3 days after 
transplant, with close outpatient follow at DFCI until 
engraftment; first day of study (Shared versus Usual 
Care) is day of neutrophil engraftment.
Shared Care
For the first 90 days, patients 
alternate between local oncologist 
and DFCI for weekly visits.
From 90 to 180 days, patients 
alternate between local and DFCI 
every 2-3 weeks.
Usual Care
Patients receive all follow-up care 
at DFCI only, which is currently 
the standard.
Expectation is that majority of 
routine visits in first 180 days will 
be at DFCI.
Data Analysis
PRO and survival analyzed on an ongoing basis by team biostatistician.
If 100-day NRM is negatively impacted by the study OR PROs are better for Shared Care arm 
study will be stopped.
Interim analysis performed when 50% accrual is reached to determine if trial should continue.
Non-randomized 
cohort 
With consent, will 
follow outcomes 
for this cohort 
which chooses not 
to be randomized 
and will receive 
usual care.

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Contents
1.0
INTRODUCTION............................................................................................................................3
1.1 OVERVIEW.......................................................................................................................................3
1.2 BACKGROUND AND RATIONALE...............................................................................................4
2.0 OBJECTIVES.........................................................................................................................................5
3.0 RESEARCH SUBJECT SELECTION...................................................................................................6
4.0 RESEARCH SUBJECT ENTRY ...........................................................................................................7
5.0 STUDY DESIGNS AND METHODS ...................................................................................................7
5.1 DESIGN/ STUDY TYPE ...................................................................................................................7
5.2 SELECTION OF INSTRUMENTS....................................................................................................7
5.3 DESCRIPTION OF INTERVENTION..............................................................................................8
5.4 DATA COLLECTION.......................................................................................................................8
5.5 DESCRIPTION OF STUDY PROCESS............................................................................................9
5.51 Instrument Administration..........................................................................................................10
5.52 Intervention Administration........................................................................................................11
5.53 Compensation .............................................................................................................................12
5.6 ADVERSE REACTION AND THEIR MANAGEMENT...............................................................12
5.61 Reporting Adverse or Unanticipated Events...............................................................................13
6.0 STATISTICAL ANALYSIS ................................................................................................................13
6.2 PATIENT-REPORTED OUTCOMES (POWERED ON FACT-BMT) ..........................................15
6.3 HANDLING OF MISSING DATA..................................................................................................15
7.0 REFERENCES.....................................................................................................................................19
8.0 APPENDICES......................................................................................................................................21
A. Patient Enrollment Information Sheet................................................................................................21
B. Short Form (SF) Post-HCT Financial Assessment.............................................................................22
C. Caregiver Quality of Life – Adapted Patient Survey .........................................................................28
D. European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) .......................30
E. FACT-BMT .......................................................................................................................................32
F. Sample Post-HCT Care Coordination Plan ........................................................................................37
G. ACT.md Education Screenshot..........................................................................................................38
H. Draft of Local Provider Education Curriculum .................................................................................39
I. ACT.md Communication Screenshot..................................................................................................40
J. Multi-Center Data and Safety Monitoring Plan (DSMP)....................................................................41

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INTRODUCTION......................................................................................................................................43
Purpose ...................................................................................................................................................43
Multi-Center Data and Safety Monitoring Plan Definitions...................................................................43
GENERAL ROLES AND RESPONSIBILITIES ......................................................................................44
DF/HCC Sponsor....................................................................................................................................44
Coordinating Center ...............................................................................................................................45
Participating Institution ..........................................................................................................................45
DF/HCC REQUIREMENTS FOR MULTI-CENTER PROTOCOLS.......................................................46
Protocol Distribution ..............................................................................................................................46
Protocol Revisions and Closures ............................................................................................................46
Informed Consent Requirements ............................................................................................................47
IRB Documentation................................................................................................................................47
IRB Re-Approval....................................................................................................................................47
Participant Confidentiality and Authorization Statement .......................................................................47
DF/HCC Multi-Center Protocol Registration Policy..............................................................................48
DF/HCC Protocol Case Number ............................................................................................................49
Safety Assessments and Toxicity Monitoring ........................................................................................50
Data Management...................................................................................................................................51
MONITORING: QUALITY CONTROL...................................................................................................51
Ongoing Monitoring of Protocol Compliance ........................................................................................51
Monitoring Reports.................................................................................................................................52
Accrual Monitoring ................................................................................................................................52
AUDITING: QUALITY ASSURANCE ....................................................................................................53
DF/HCC Internal Audits.........................................................................................................................53
Audit Notifications .................................................................................................................................53
Audit Reports..........................................................................................................................................53
Participating Institution Performance .....................................................................................................53
K. Shared Care Patient Schedule (Example) ..........................................................................................55
1.0INTRODUCTION
1.1 OVERVIEW
Hematopoietic cell transplantation (HCT), commonly known as bone marrow transplantation, is 
the only potentially curative treatment for many advanced hematologic malignancies.1-3 It is a 

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highly technical inpatient procedure that is only available at select centers in the United States: 
those that have the capacity for collecting and storing hematopoietic stem cells, as well as caring 
for patients before the new immune cells take hold. For this reason, many patients who undergo 
HCT live at great distances from their HCT center. Moreover, after hospital discharge, the first 
180 days post-HCT are critical. Patients must be watched closely for infections and/or the 
development of graft-versus-host disease (GVHD) and specialized anti-rejection medications 
must be tightly managed. For those who live far away, the need for close follow-up for such a 
long period can cause a great burden in terms of familial finances, impact on caregivers, and 
compromised quality of life.4-6 
One way of potentially ameliorating these effects is to allow some of the post-HCT care to be 
provided by non-HCT oncologists who practice closer to where patients live. Such a model could 
reduce patient-centered burdens post-HCT; however, it is not known if, given its complexity, 
post-HCT care can truly be “shared” between HCT specialists and local oncologists without 
compromising HCT-related outcomes. We aim to assess the effectiveness of a Shared Care 
program which allows patients to receive half of their post-HCT care at the HCT center, and the 
other half with their local oncologist.
1.2 BACKGROUND AND RATIONALE
HCT has become a standard treatment option for many advanced blood cancers. According to 
the Center for International Blood and Marrow Transplantation Research (CIBMTR), the overall 
number of allogeneic HCTs in adults in the US surpassed 8,000 per year in 2013, with 8,351 in 
2015.7 In addition, likely due to advances in approaches to infectious disease and other HCT 
complications, outcomes have significantly improved. Such good news about the increasing 
availability of HCT has contributed to improvement in the length of life of those transplanted.8
Although many HCT survivors eventually return to baseline health, those who undergo an 
allogeneic procedure (receiving cells from another person) are at particular risk of experiencing 
short- and long-term effects of the procedure itself. These include rare and common infections, 
GVHD (acute or chronic), and many other issues that, in addition to the ever-present concern for 
disease relapse, require diligent monitoring by the HCT team after discharge from the initial 
inpatient procedure. Usual care for patients after HCT at most centers consists of returning to the 
HCT center weekly for the first three months and bi-weekly for the next three months (except for 
emergency care). This intense visit schedule for the first 180 days can be very difficult for 
patients who live far away in terms of their quality of life (QOL) and personal financial well-
being, and distance from transplant center may even impact survival. For example, it has been 
shown that long driving time (≥160 min) to the HCT center is associated with a decreased 
likelihood of being disease-free one year after the procedure.8 
Until recently it was not known if living far away from the HCT center was associated with 
compromised post-HCT familial finances and/or QOL. A pilot study assessing patient and 
caregiver costs in the first three months after HCT (n=30)9 revealed that the median out-of-

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pocket cost was over $2,000 (range: $199 to $13,769), and that patients/caregivers who required 
temporary lodging had higher expenses compared with those who did not. Another study of 
allogeneic HCT survivors (assessed a median of 2.3 years after the procedure) found that 47% 
reported ongoing financial burden after HCT – defined as household income decreased by >50%, 
selling/mortgaging home, or withdrawing money from retirement accounts.10 With 268 
respondents (56% response rate), 73% reported that having had an HCT “hurt them financially.” 
These analyses show familial financial hardship to be prevalent shortly after HCT, but do 
not reveal if it is associated with worse patient-reported outcomes such as QOL during this 
period.
We recently completed a multi-site survey of adult patients approximately 180 days after HCT 
(DFCI protocol 14-144; n=325; 72% response rate) to assess the familial financial hardship they 
might experience after HCT, its sources, and its effect on patient QOL. Income decline was 
reported by 46% of patients from DFCI center as well as two others (Mayo Clinic in Phoenix, 
AZ and Roswell Park in Buffalo, NY); 57% reported financial hardship after HCT (defined as 
dissatisfaction with present finances, difficulty meeting monthly bill payments, or not having 
enough money at the end of the month), and 16% reported extreme hardship (all three).4,11,12 In 
multivariable models controlling for income, those reporting HCT-related costs such as travel 
to the HCT center were more likely to report post-HCT income decline and extreme 
financial hardship. Moreover, reporting financial hardship was in turn associated with reporting 
QOL below the median (OR 3.0 [1.8, 5.0]), health status below the median (OR 2.2 [1.4, 3.6]), 
and stress above the median (OR 2.1 [1.3, 3.5]) as assessed by the PSS-4, a validated measure of 
perceived stress.13-15 
At most HCT centers, patients are required to return to the center itself for the bulk of their 
follow-up even if it is very far away from their home. Another care delivery model used by some 
centers is to discharge patients completely to local providers (primary care or oncology) shortly 
after the procedure. Unfortunately, primary care physicians and local non-HCT oncologists often 
lack sufficient education to manage complex HCT issues, and such models can also leave 
patients feeling unsupported after having been in the hospital for almost a month after their 
initial procedure.16,17 In contrast, we have created a new post-HCT delivery model in which both 
local oncologists and transplant oncologists work together to care for patients after HCT. We call 
this model “Shared Care,” and plan a randomized controlled trial to test its effectiveness in 
improving patient-reported outcomes (PROs).
2.0 OBJECTIVES
This study will assess the effectiveness of a shared approach to post-HCT care to Usual Care (all 
care at DFCI) with respect to highly-relevant PROs and traditional HCT outcomes. We aim to:
1. Compare highly-relevant PROs for Shared versus Usual Care at 180 days post-HCT.
2. Compare 100-day non-relapse mortality (NRM) for patients in Shared Care versus 
Usual Care.

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3.0 RESEARCH SUBJECT SELECTION
Overall, 324 patients will be recruited and consented on-site at DFCI to participate in this 
randomized controlled trial. Annually, approximately twenty participants will be recruited to 
share care with each site. Post-HCT visits for the 162 patients randomized to Shared Care will 
occur about 50% at Dana-Farber and 50% at the local site, supported through an innovative web-
based provider communication portal (ACT.md). The local sites are:
1. Lifespan Cancer Institute (Providence, RI; 21 participants per year)
PI: John Reagan (jreagan@lifespan.org)mailto:
IRB Manager:  Andrew Schumacher (ASchumacher@Lifespan.org)
2. Dartmouth-Hitchcock (Lebanon, NH; 20 participants per year)
PI: Kenneth Meehan (Kenneth.R.Meehan@hitchcock.org)
IRB Manager: Dianne Ferris (Dianne.M.Ferris@dartmouth.edu)
3. New York Oncology Hematology (Albany, NY; 20 participants per year)
PI: Ira Zackon (ira.zackon@usoncology.com)
IRB Manager: Chris Kritzman (chris.kritzman@usoncology.com)
4. New England Cancer Specialists (Brunswick, Maine; 14 participants per year)
PI: John Winters (wintej@newecs.org)
Covered by Dana-Farber IRB
5. Eastern Maine Medical Center (Brewer, Maine, 14 participants per year)
PI: Rodrigo Maegawa (rmaegawa@emhs.org)
IRB Manager: Laurie Lewis (llewis@emhs.org)
6. DFCI Community Cancer Care and Satellites (Weymouth and Milford, MA; 20 
participants per year)
PI: Michael Anderson (MichaelJ_Anderson@dfci.harvard.edu)
Covered by Dana-Farber IRB
Inclusion criteria include: 
1. Age >= 18 years of age
2. Scheduled to receive an allogeneic HCT at the Dana-Farber Inpatient Hospital or 
BWH under the care of a DFCI physician.
3. Residence in New York, Maine, New Hampshire, Vermont, Connecticut, Rhode 
Island, or Massachusetts.
4. Referred from one of the above six centers, or chooses to receive care at one of the 
six centers.
5. Ability to read English (to fill out standard QOL forms)
Exclusion criteria include:
1. Age <18 years of age
2. Scheduled to receive an autologous HCT

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3. Has received an allogeneic transplant in the past; scheduled to receive a second 
allogeneic transplant
4. Did not receive an allogeneic HCT at Dana-Farber
5. Does not live in New York, Maine, New Hampshire, Vermont, Connecticut, Rhode 
Island, or Massachusetts.
4.0 RESEARCH SUBJECT ENTRY
Potential study participants will be informed of the study during their first consultation with an 
HCT physician and/or nurse at DFCI (an information sheet [Appendix A] will be added to the 
Guide to Transplant binder). Study consent will take place at the same time patients consent to 
HCT, which is always on a subsequent visit. Potential participants will be given the opportunity 
to ask questions, opt out of consideration, and take a consent form home to discuss further with 
their family and/or other clinicians. We will also be clear that enrollment does not guarantee 
assignment to Shared Care, and that there will be a 50% chance they will assigned to Usual 
Care, which means outpatient routine follow-up exclusively at Dana-Farber in Boston.
Once recruited, all study participants will be registered in the DFCI OnCore Clinical Trial 
Management System by the Research Assistant. Institutions will register eligible participants in 
the Clinical Trials Management System (CTMS) OnCore as required by DF/HCC SOP REGIST-
101. When required by REGIST-101, registration must occur prior to the initiation of protocol-
specific procedures or assessments.
Registration requires a signed informed consent document and a completed eligibility checklist 
according to DF/HCC SOP REGIST-104.
Patient enrollment happens after stem cell infusion. Patients will not be enrolled if the transplant 
is canceled prior to Day 0.
5.0 STUDY DESIGNS AND METHODS
5.1 DESIGN/ STUDY TYPE
We propose a randomized control trial with two arms. Participants will be randomized 1:1 to the 
intervention arm (Shared Care) or to the conventional arm (Usual Care). Randomization will be 
stratified by site and conditioning intensity (Full vs Reduced intensity).
5.2 SELECTION OF INSTRUMENTS
Data will be collected via medical record reviews and four PRO surveys: (Short Form [SF] Post-
HCT Financial Assessment (Appendix B), Caregiver Quality of Life – Adapted Patient Survey 
(Appendix C), EORTC QLQ-C30 (Appendix D), and FACT-BMT (Appendix E). Medical record 
review will include sociodemographic information, diagnoses, recurrence, surgical procedures, 
cardiac events, and mortality. Patient survey data will include measures of the chosen PROs. All 
data will be entered into a password-protected RedCap database, with hard copies stored in 
locked file cabinets. 

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5.3 DESCRIPTION OF INTERVENTION
Shared Care involves four specific strategies to allow patients to be followed locally after HCT, 
where clinic and laboratory visits are equally shared between the local oncologist and primary 
HCT team. The challenges of delivering complex care will be met by addressing communication 
and knowledge gaps within each stakeholder group (transplant physician, local oncologist and 
patients/caregivers). As such, we have broken down the Shared Care intervention into four 
targeted components: 
1.
Formal Care Coordination Plan (CCP): A comprehensive online document created 
pre-HCT that will clearly define responsibilities of patients and their two teams of 
providers. This will freely available for review by all three groups (Appendix F).
2.
Patient Engagement and Education: The DFCI HCT program has numerous resources 
for patient education, covering nutrition, medication, and infection prevention. This 
includes the Stem Cell Education: An Information Guide for Patients and Caregivers, 
access to an online portal (sctpatiented.dana-farber.org – password dfci), and a 
transplant-specific CancerConnect community. Both Shared Care patients and Usual 
Care patients will receive all of these materials; Shared Care patients will also have 
specific pieces of education “pushed” to them through the ACT.md portal (Appendix 
G).
3.
Local Oncologist Engagement and Education: Shared Care local oncologists will 
attend a three-day conference at DFCI’s HCT center before patient enrollment starts, 
aimed to address knowledge gaps and to educate them in management of HCT 
complications. For draft curriculum see Appendix H. There will also be yearly 
follow-up education at Dana-Farber which will feature review of post-HCT clinical 
scenarios and clear protocols for reaching out to the primary HCT team. Additionally, 
Dr. Abel and Dr. Ho will visit each of the local sites annually to discuss the study and 
answer any transplant-related questions.
4.
Patient/Local Oncologist/Transplant Oncologist Web Portal: A patient-facing 
centralized web platform (ACT.md) will ensure timely communication with the two 
teams of providers, patients, and their families. The web portal will also be available 
for patients to share with emergency providers that they see locally (Appendix I).
5.4 DATA COLLECTION
A detailed Multi-Center Data and Safety Monitoring Plan Template (DSMP) is available in the 
Appendices (Appendix G).
Patient-Reported Outcomes: In a recent study (17-088) a modified Delphi technique was used to 
determine the optimal PROs and collection methods to measure patient quality of life after 

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transplant. Per the results of the study, patients will be asked to fill out the (SF) Post-HCT 
Financial Assessment (Appendix B), Caregiver Quality of Life – Adapted Patient Survey 
(Appendix C), EORTC QLQ-C30 (Appendix D), and FACT-BMT (Appendix E). The 
participants deemed that four surveys in one sitting is appropriate, since each of the surveys takes 
approximately 5 minutes to complete (for a total of 20 minutes to take all four surveys). All 
patients will be asked to complete PROs at DFCI visits close to 100 days and 180 days post-
transplant. These surveys will be administered and collected by the research assistant.
HCT-Related Outcomes: We have chosen 100-day non-relapse mortality (NRM), as this is a 
standard measure for much of the clinical trial literature surrounding upfront interventions in 
HCT. We will also measure overall survival (OS) and GVHD symptoms. However, 100-day 
NRM is more directly applicable because it will be assessed during the critical time of the Shared 
Care intervention, which lasts 180 days. Transplant data management is unique in that all U.S. 
transplant centers are required to submit outcomes data for each allogeneic transplant they 
perform to the national Stem Cell Therapeutic Outcomes Database. To ensure all data are entered 
in a timely manner, the DFCI team will 
perform data quality review quarterly, and 
follow up on any delayed data entry for each 
patient enrolled.
5.5 DESCRIPTION OF STUDY 
PROCESS
This study of the effectiveness of the Shared 
Care method will be conducted with a 
randomized control trial comparing Shared 
Care and Usual Care. There will be 324 
participants. Please see the protocol schema 
for the study time line. To review: 
Pre-Transplant:
1. Recruit participants. Patient sign informed consent on day of overall HCT consent.
2. Patients randomized to one of two arms of the study.
Transplant:
Month 1: Patients admitted to DFCI or BWH for transplant. Receive stem cells.
1. Patients receiving full intensity allogeneic HCT will remain at the hospital for 
approximately 30 days.
Figure 1. The Shared Care Study Process

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2. Patients receiving a reduced intensity chemotherapy (RIC) HCT will be discharged 
approximately 1-2 days post-transplant. However, they will remain in Boston to 
attend frequent clinic visits until engraftment (10-12 days post-transplant).
Post-HCT: Full Intensity
Start of Shared Care: Patients will be discharged from hospital. Usual Care patients return to 
DFCI for all scheduled appointments through 180 days. Shared Care patients adhere to the 
following schedule:
1. For the first 90 days post-transplant, patients will alternate between local oncologist 
and DFCI for weekly visits.
2. From 90 to 180 days post-transplant, patients will alternate between local and DFCI 
every 2-3 weeks.
Post-HCT: Reduced-Intensity
Start of Shared Care: After evidence of engraftment at follow-up DFCI patient visits (ANC 
>500).  Usual Care patients return to DFCI for all scheduled appointments through 180 days. 
Shared Care patients adhere to the following schedule:
1. For the first 90 days post-transplant, patients will alternate between local oncologist 
and DFCI for weekly visits.
2. From 90 to 180 days post-transplant, patients will alternate between local and DFCI 
every 2-3 weeks.
For patients who have not already established care with their designated local oncology team, a 
visit will be scheduled with that provider before HCT admission. An example of a Full Allo 
Shared Care patient’s potential schedule is provided in Appendix K.
Premature termination of Shared Care:
Patients who relapse or require a second transplant will remain on protocol for QOL assessment 
but will no longer share care as part of the protocol.  
5.51 Instrument Administration
In addition to the standard data collection that is required for all patients who undergo HCT in 
the United States (CIBMTR)—including NRM and overall survival (OS)—all patients will be 
asked to complete PROs at 100 days and 180 days post-transplant, including any patients that 
prematurely terminate Shared Care for any reason. This was determined based on 
recommendations made by the modified Delphi panel of patients from a previous study (17-088). 
PROs will focus on assessing physical, social, and emotional wellbeing. 

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To understand the care that is received by individuals who choose not to be randomized, for 
those who consent, the study will track in parallel fashion their HCT-related outcomes and 
PROs. This will provide a non-randomized observational cohort which will be a second source 
of analysis and will also allow us to determine if there is a participation bias for those 
randomized. Given exuberant non-randomized (NR) enrollment and since NR participants are 
not included in our main analysis, we will cap the number of participants enrolled in the non-
randomized arm at 1 patient per month. This will further lessen the burden of data collection 
with our limited resources and will allow us to better utilize the time of our research assistant 
involved in data collection.  Patients declining randomization will receive usual care following 
HCT at Dana-Farber. 
5.52 Intervention Administration
Along with care at DFCI, patients randomized to Shared Care will receive half of their care at 
one of six community practice sites (Stamford Hospital, Dartmouth-Hitchcock, New York 
Oncology Hematology, New England Cancer Specialists, Eastern Maine Medical Center, and 
DFCI Community Cancer Care/Dana-Farber Satellites). 
Each local site will be responsible for obtaining local IRB approval after OHRS approval at 
DFCI (except for DFCI Community Cancer Care/Dana-Farber Satellites), and all Shared Care 
Investigator Group (SCIG) members (DFCI and local) will require receipt of education in the 
protection of human research participants (CITI training). Site investigators and clinicians will 
also receive HCT training in post-HCT care in Boston, and training in the use of the selected 
HIPAA-compliant web app, ACT.md. ACT.md will be used as a communication platform for 
patients, local oncologists, and transplant oncologists during Shared Care. Clinical outcomes will 
be collected in government-mandated systems already in place for HCT patients at DFCI and 
maintained by the Dana-Farber Department of Research Computing. PROs during the first 180 
days will be collected by the Research Assistant when patients are at Dana-Farber. 
GVHD is a potential outcome of an allogeneic HCT transplant. It is a condition where the new 
cells attack the recipient’s tissues, such as the skin and gastrointestinal tract, and specialized anti-
rejection medications must be managed closely. The GVHD-related tasks segment of ACT.md 
will be very detailed because local oncologists will be most unfamiliar with looking for and 
treating GVHD. There will be a flowsheet integrated in the system that will document the level 
of GVHD if any.18
Shared Care will start on the first clinic visit after stem cell engraftment (reduced intensity 
transplant), or after hospital discharge (myeloablative transplant). Importantly, we will aim to 
have the first post-engraftment or post-discharge visit for patients randomized to Shared Care to 
occur locally even if patients are experiencing post-transplant complications. Transplant teams 
will provide a “warm pass-off” to the local team before this visit, send a discharge summary of 
the inpatient stay, and make sure that the online comprehensive care plan is reviewed by all 
parties. 

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ACT.md is a crucial component of Shared Care. To avoid gaps in communication between 
physicians, both local and DFCI oncologists will update each Shared Care patient’s profile as 
they are meeting with the patient. Each provider will write a short visit summary that will be 
visible both to the other care team and the patient (Appendix I). The note will comprise salient 
information for the next visit without duplicating the medical record. Providers will be 
encouraged to call or page one another if an issue is urgent or needs to be discussed in more 
detail.
Patients will be able to post messages to their care teams in a limited capacity. However, there 
will be clear communication that messages sent through ACT.md will not be checked in real 
time, and any issues that require immediate attention would require going to the ER. 
Two trained Shared Care physicians will be present at each participating site; however, there will 
be some physicians who are not part of Shared Care but who will find themselves covering these 
patients on nights, weekends and vacations. Some providers and patients may feel uncomfortable 
with a rapid transition of care, which could curb their overall enthusiasm to participate in Shared 
Care. To ease their concerns, we will ensure a dedicated “Shared Care” transplant attending at 
Dana-Farber will be available on page at all times for consultation. This call schedule and paging 
information will be available for each doctor at the Shared care local sites, and continuously 
updated. 
During scheduled monthly calls and periodic on-site visit from the Dana-Farber PIs (Drs. Abel, 
Antin, and Ho), the local oncologists will have an opportunity to discuss any patients they want 
additional guidance from the transplant oncologists. 
ACT.md will be available via smartphone, tablet or computer. If patients do not have access to 
one of these platforms, we will supply them with a tablet and/or a WiFi card. 
5.53 Compensation
The patients will receive no compensation for their participation. 
5.6 ADVERSE REACTION AND THEIR MANAGEMENT
A potential area of concern is that there may not be continuous communication among patients, 
DFCI transplant providers, and local providers. For this reason we have created the ACT.md web 
tool for providers to communicate with each other in real time and for patients to directly 
observe – and potentially add to – this communication (see section 5.52).
The non-randomized cohort of patients will receive Usual Care following their HCT procedure. 
They will be subject to the same medical record reviews and surveys in the Usual Care arm. 
The consent forms outline the risks associated with participation. The risks to both the 
randomized and non randomized cohorts are expected to be minimal and all attempts will be 
made to minimize any anticipated issues with communication. If a patient declines 

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randomization and collection of outcomes, then the patient declines complete participation, s/he 
will not sign informed consent, will not be in this research study and no data will be collected.
The coordinating center (Dana‐Farber) will take several steps to protect against and to minimize 
risks to privacy of individuals and confidentiality of data:
1. All data analyses will be conducted at Dana‐Farber under the direct supervision of the PI.
2. Once the data are received, all study data will be stored on a password‐protected RedCap 
database.
Data will be used for research purposes only. At no time will any patient be individually 
identified in the final analyses. We are confident that the steps outlined above will effectively 
protect against this risk.
Estimated study population characteristics are presented in Table 3, which are derived from our 
recent survey of patients at 180 days after HCT (in the table, autologous patients are 
excluded).4,11,12 The response rate we achieved (72%) provides insight into the high level of 
engagement of HCT patients and caregivers, even when concerning difficult topics such as 
personal finances.
Finally, to address study risk of missed tasks and miscommunication, we have planned interim 
analyses to determine if there are worse HCT-related outcomes for Shared Care patients; if so, 
the study will be stopped immediately and patients returned to usual care. 
5.61 Reporting Adverse or Unanticipated Events
Any unanticipated event will be reported to the IRB and the DSMB. Interim analyses will help 
determine if there are worse HCT-related outcomes for Shared Care patients; if so, the study will 
be stopped immediately and patients returned to usual care
6.0 STATISTICAL ANALYSIS
In September and October of 2015, we undertook 32 in-depth qualitative interviews with patients 
in both care models (Table 1). 8 patients had experienced Shared Care, and 24 patients had 
received all their post-HCT care in Boston (Usual Care). Of the latter, 20 (83%) specifically 
stated they would have been willing to receive some of their post-HCT care locally. Perhaps 

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most impressive was this 
comment by a patient who had 
been cured of acute myeloid 
leukemia by a HCT at our center: 
“I live an hour north of Portland 
[Maine] so Dana-Farber was the 
closest place for my transplant. I 
was in the hospital in Boston for 
about a month for the transplant, 
and discharged on a Saturday. I 
was very weak, had low blood 
counts, and was still taking oral 
antibiotics for an infection I had 
contracted in the hospital. After a 
three-hour ride home, on Monday I had to turn around and go back to Dana-Farber. Honestly, 
my husband and I almost couldn’t face it—and we had to do this trip every week for several 
months.” Additional patient comments from our interviews are detailed in Table 1.
In 2014-2015, an average of 136 patients per year was referred from the 6 participating potential 
Shared Care sites for allogeneic HCT. Assuming similar number of patients will continue to 
undergo allogeneic HCT referred from these sites, and considering our qualitative interviews 
(Table 1) in which 83% of patients stated they would have wanted to receive some post-HCT 
care locally, we project approximately 80% will agree to be randomized to Shared or Usual Care 
(108 per year; Table 2). With 3 years of accrual, we anticipate a total of 324 randomized patients 
(162 in Shared Care and 162 in Usual Care), as well 108 non-randomized patients who will also 
receive usual care.
6.1 GENERAL DESCRIPTION AND CHARACTERISTICS OF DFCI HCT PATIENT 
POPULATION 
Estimated study population characteristics 
are presented in Table 3, which are derived 
from our recent survey of patients at 180 
days after HCT (in the table, autologous 
patients are excluded).4,11,12 More detail 
about PROs, handling of missing data, and 
heterogeneity of effects are detailed below.
Table 1.  Sample of Shared Care and Usual Care Patient Feedback
“It’s always very inconvenient [to come to Boston]...I’d be happy to see Dr. X 
occasionally and see my local oncologist more often, as long as there is 100% 
communication between the two. I would want to be able to confirm that they are 
talking.”—L.B., Usual Care 
“I got great care with my doctors at NYOH, and they really did their best to fight for me. 
I am glad I still saw the team at Dana-Farber as well.”—J.I., Shared Care
“If it’s something routine like blood counts, seeing a local oncologist would be OK. But 
what if I got really sick—how would Dana-Farber know? I am not sure that I would 
want my private information sent by email. Is it secure? ”—W.S., Usual Care
“Every time [visiting Dana-Farber] is inconvenient. I have to drive over 3 hours each 
way and I can’t do that in one day. Seeing my NYOH doctor is so much better since I 
don’t have to spend money on hotels, gas or food.”—M.G., Shared Care
“I would never want to get my post-HCT only in NH. I like my oncologist, but I would 
be scared that they wouldn’t know what to do.”—A.G., Usual Care
“We live in Caribou [Maine], but use the Internet every day. Why can’t we use it to 
make communication between my old team and my new one better?”—W.J., Shared 
Care
“I live pretty close to Boston (about 35 minutes), but is still difficult to get in and see Dr. 
X; I would love to be able to see my local oncologist who is down the street.”—D.S., 
Usual Care
Table 2.  Shared Care Participating Sites and Number of Allogeneic 
HCT  Patients in 2014 and 2015; Estimates for Accrual Per Year
Proposed Shared Care Sites
State
Mean DFCI
Allo HCT
2014 & 2015
If 80% 
agree to 
RCT/yea
r
Stamford Hospital
CT
27
21
Dartmouth–Hitchcock 
NH/VT
25
20
New York Oncology Hematology
NY
26
20
New England Cancer Specialists
S. ME
17
14
Eastern Maine Medical Center
N. ME
17
14
DFCI CCC/Satellites
MA
25
20
Total
136
108

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6.2 PATIENT-REPORTED OUTCOMES (POWERED ON FACT-BMT)
Our primary hypothesis is that patients in the Shared Care 
group will have improved PROs compared to those in Usual 
Care due to a decreased burden of traveling and/or relocation 
to the HCT center. To investigate this hypothesis, the 
primary endpoint of this aim is powered by an expected 
improvement in FACT-BMT score between Shared Care to 
Usual Care 180 days post HCT. Of the total 324 patients 
who are randomized at study entry, we project that 80% will 
be alive at six months after allogeneic HCT and 70% will 
participate in the day 180 PRO assessment. These 
projections are based on survival data of DFCI HCT patients 
between 2012 and 2015, and the response rate from our prior 
survey regarding financial hardship experienced at 180 days 
after HCT described above (DFCI RR=72%; Table 5). This 
yields a sample size of 180. In a previous study of QOL for 
patients after allogeneic HCT, the mean FACT-BMT score at 
100 days after HCT was 110 (±20).19 Therefore, we believe a 
difference of 20 or more will be meaningful to show 
improved PROs at a similar time period (day 180). 
Extrapolating from this information, if the FACT-BMT score 
is 120 for Shared Care and 100 for Usual Care at 180 days 
post-HCT, there will be >99% power to detect this 
difference. If, however, the difference is 10, then there will 
be 90% power to detect this difference. This power 
calculation is based on asymptotic power of the Wilcoxon-
Rank-Sum test against an alternative shift at the two sided significance level of 0.05, assuming 
the standard deviation of the difference is 20. An additional preliminary endpoint is expected 
difference in mean PSS-4, one of the potential quality of life surveys, score at day 180 post-
HCT. In our financial hardship survey, the mean PSS-4 score for DFCI allogeneic patients 
(n=139) was 5.6 (±3.2). Extrapolating from these data, if the difference in PSS-4 between the 
Shared and Usual Care groups is 2 with standard deviation 3.2, there will be 98% power to detect 
this difference at the two-sided significance level of 0.05.
6.3 HANDLING OF MISSING DATA 
We will make every effort to collect all PRO data from study participants. We will collect these 
data in-person at the DFCI clinic visit closest to 180 Days (and additionally at earlier time points 
according to the results of 17-088) which, as compared to a mailed design, will help assure 
compliance. If a QOL survey is not completed, the PI or co-PI will personally contact each 
patient to ensure return at the next clinic visit. If patients do not complete the PROs despite 
personal contact by the PI, they will be regarded as non-responders (dropouts). We will record 
Table 3.  Sample DFCI Allogenic HCT Patient 
Characteristics (n=139)
Patient Characteristics
%* 
Diagnosis 
 
  Acute Myeloid Leukemia
35
  Myelodysplastic Syndromes (MDS)
20
  Myeloproliferative Neoplasms
15
  Acute Lymphoblastic Leukemia
15
  Other
15
Sex
 
  Female
41
  Male
59
Age
 
 60 or under
50
 Over 60
50
Race
 
  White
96
  Non-white
4
Insurance Type
 
  Employer sponsored
64
  Government sponsored
29
  Self-insured
7
Employment Status
 
  Employed
49
  Unemployed
4
  Not in the labor force (e.g., retired)
48
Marital Status
 
  Married
73
  Not married
27
Education
 
  BA/Graduate Degree
49
  No BA/Graduate Degree
51
Monthly Income
 
  Low income (< $3,000)
28
  Middle income ($3,000 to $6,999)
45
  High income (>$7,000)
27
*All categories do not equal 100% due to rounding

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all reasons for dropouts, and account for all patients in reports, whether or not they have dropped 
out. Of note, those who do not agree to participate (~30%) for the PRO assessment will not be 
regarded as missing.
We will take a standard approach to handling 
individual missing items on PROs that are received. 
For example, if item(s) are unanswered in FACT-
BMT, subscale scores will be prorated by 
multiplying the sum of the subscale by the number 
of items in the subscale and then dividing by the 
number of items actually answered. Multiple 
imputation is a well-known approach for handling 
missing data. While this approach is a valid method 
for imputing missing independent variables to 
preserve study power, imputing outcome variables is 
more difficult, as this may introduce bias into the 
study conclusions. We will thus take several 
approaches to handling missing data from dropouts. First, to assure PRO scores for non-
responders are missing at random, we will perform a sensitivity analysis comparing the patient, 
HCT characteristics, and clinical outcomes between responders and non-responders. Second, we 
will perform multiple imputation on the outcome variable (including all independent variables) 
and compare the result without multiple imputation (i.e., inclusion of responding patients only). 
More importantly, with voluntary patient consent to participate in the study and proactive 
collection of survey data by the research team, we anticipate that the non-compliance rate will be 
minimal (<5%). Moreover, we anticipate that there will be no missing independent variables in 
all HCT patient-related data as this data must be reported to the CIBMTR database by the 
DFCI/BWH HCT center. Finally, to assure the robustness of our results, we will compare the 
FACT-BMT scores of the randomized Usual Care cohort with the non-randomized usual care 
cohort.
6.4 Non-relapse Mortality
The population for the analysis of NRM will be all participants who are randomly assigned to 
receive either Shared Care or Usual Care based on an intent-to-treat principle (n=324), meaning 
that the patients will be analyzed according to their randomly assigned treatment, regardless of 
how they may have actually been treated. The primary hypothesis of this aim is that HCT-related 
clinical outcomes will not be compromised in the Shared Care group (i.e., non-inferiority test). 
Causes of death after allogeneic HCT can be due to relapse of the primary diagnosis, but also due 
to causes other than the disease itself such as infection, GVHD, or organ failure which are 
termed “non-relapse mortality (NRM).” 100-day NRM will be the primary outcome, as it is 
most sensitive to quality of post-HCT care. Other endpoints in this aim include overall survival, 
progression-free survival, relapse, emergency room admissions, infections, and GVHD. Between 
2012 and 2015, the 100-day NRM rate at DFCI was 2-3%. Based on this information, the 
Figure 2. Power for Non-Inferiority Test (NRM)

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hypothesis of testing non-inferiority of Shared Care is defined such that the difference in 100-day 
NRM rate is not greater than a non-inferiority margin of 5%, that is: 
Ho: Ps-Pu≥0.05; Ha: Ps-Pu<0.05
where Ho and Ha denote the null and alternative hypothesis, respectively, Ps denotes the 100-day 
NRM rate in the Shared Care group and Pu denotes the rate in the Usual Care group. For 
example, if the 100-day NRM rate is 2% in the Usual Care group and 3% in the Shared Care 
group, there will be 85% power of rejecting the null hypothesis of inferiority at one-sided type I 
error rate of 0.1 (Figure 2). If, however, the 100-day NRM is 3% in the Usual Care and 3.7% in 
the Shared Care group, there will be 81% power of rejecting the null hypothesis of inferiority. 
This power calculation is based on a Pearson chi-square test for two proportions using PROC 
POWER in SAS v9.2. Finally, when the study reaches 50% of its accrual (n=162) and the last 
patient in this set is followed for 100 days, we will perform an analysis of 100-day NRM to 
ensure the difference in the 100-day NRM rate is within a 5% non-inferiority margin (an 
“interim look.”) If the 100-day NRM rate in Shared Care is 
> 5% higher than that in Usual Care, accrual will be halted 
pending review by the Data Safety Monitoring Board. The 
DSMB may recommend permanent closure of enrollment 
or continuation of the study. Of note, there may be a small 
attrition in type I error rate due to the interim look, which is 
not incorporated in the above error rate of 0.1.
The data analysis will be based on the intent-to-treat 
principle. The 100-day NRM will be analyzed as a binary 
outcome as well as in the competing risks framework 
treating relapse as a competing event, with the latter being the primary analysis. In the competing 
risks data analysis, we will examine whether the competing event of relapse is similar between 
the two types of care. Other endpoints in this aim include overall survival, progression-free 
survival, NRM, relapse, and a/c GVHD. For overall and progression-free survival, standard 
survival analysis will be performed, including the Kaplan-Meier method for estimation of 
survival functions, log-rank test for comparison of KM curves, and Cox proportional hazards 
model for multivariable regression analysis. For NRM, relapse and a/c GVHD, competing risks 
data analysis will be performed. Since these endpoints are immunologically intertwined, it is 
critical to analyze them in a competing risks framework.20,21 In addition, we will perform a 
sensitivity analysis comparing baseline characteristics and clinical outcomes between the Shared 
Care and the non-randomized usual care group, and between the randomized Usual Care group 
and the non-randomized usual care group. Again, we anticipate no missing data in HCT clinical 
outcomes since reporting of HCT-related outcomes data to the CIBMTR is mandatory
6.5 HETEROGENEITY IN TREATMENT (HTE) EFFECTS
Heterogeneity of the group effect (Shared Care vs. Usual Care) on outcomes will be examined 
for pre-specified patient, donor, disease and transplant related attributes (Table 4). The attributes 
Table 4. Pre-specified Attributes to Examine 
Heterogeneity
Patient 
attribute
Age
Patient sex
CMV seropositive status
Donor 
attribute
Donor sex
Donor type: related vs. unrelated
HLA type: matched vs. mismatched
CMV seropositive status
Disease 
attribute
Blood Cancer Diagnosis
Disease status
Transplan
t attribute
Conditioning intensity
GVHD prophylaxis
Graft source

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shown are known risk factors for allogeneic HCT. Since this is a randomized study, we 
anticipate that all these attributes will be well balanced between two groups. With respect to 
patient gender and ethnicity, we are aware of no data that would lead us to expect differential 
effects of treatments in allogeneic HCT by gender and ethnicity. However, when the proposed 
study is completed, we will perform a multivariable linear regression analysis on FACT-BMT 
and PSS-4 including attributes shown in Table 4 and type of care (Shared vs. Usual) to identify 
factors associated with a better outcome. In addition, we will test interactions between each 
group (Shared vs. Usual) and attributes. If any of these attributes perform better in one group 
over the other, we will report the results to facilitate further investigation in future studies.

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7.0 REFERENCES
1.
Ljungman P, Urbano-Ispizua A, Cavazzana-Calvo M, et al. Allogeneic and autologous 
transplantation for haematological diseases, solid tumours and immune disorders: 
definitions and current practice in Europe. Bone marrow transplantation. Mar 
2006;37(5):439-449.
2.
Copelan EA. Hematopoietic stem-cell transplantation. N Engl J Med. Apr 27 
2006;354(17):1813-1826.
3.
Escaron AL, Chang Weir R, Stanton P, Vangala S, Grogan TR, Clarke RM. Testing an 
Adapted Modified Delphi Method: Synthesizing Multiple Stakeholder Ratings of Health 
Care Service Effectiveness. Health Promot Pract. Mar 2016;17(2):217-225.
4.
Abel G, Salas-Coronado D, Albelda R, et al. Prospective assessment of familial financial 
hardship after hematopoietic cell transplantation (abstract). Biology of Blood and Marrow 
Transplantation. 2015;21:572.
5.
Beattie S, Lebel S. The experience of caregivers of hematological cancer patients 
undergoing a hematopoietic stem cell transplant: a comprehensive literature review. 
Psychooncology. Nov 2011;20(11):1137-1150.
6.
Polomeni A, Lapusan S, Bompoint C, Rubio MT, Mohty M. The impact of allogeneic-
hematopoietic stem cell transplantation on patients' and close relatives' quality of life and 
relationships. Eur J Oncol Nurs. Apr 2016;21:248-256.
7.
D'Souza A, Zhu X. Current Uses and Outcomes of Hematopoietic Cell Transplantation 
(HCT): CIBMTR Summary Slides. http://www.cibmtr.org2016.
8.
Abou-Nassar KE, Kim HT, Blossom J, et al. The impact of geographic proximity to 
transplant center on outcomes after allogeneic hematopoietic stem cell transplantation. 
Biology of blood and marrow transplantation : journal of the American Society for Blood 
and Marrow Transplantation. May 2012;18(5):708-715.
9.
Majhail NS, Rizzo JD, Hahn T, et al. Pilot study of patient and caregiver out-of-pocket 
costs of allogeneic hematopoietic cell transplantation. Bone marrow transplantation. Jun 
2013;48(6):865-871.
10.
Khera N, Chang YH, Hashmi S, et al. Financial burden in recipients of allogeneic 
hematopoietic cell transplantation. Biology of blood and marrow transplantation : 
journal of the American Society for Blood and Marrow Transplantation. Sep 
2014;20(9):1375-1381.
11.
Khera N, Albelda R, Hahn T, et al. Association of Psychosocial Outcomes with Familial 
Financial Hardship after Hematopoietic Cell Transplantation (abstract). Paper presented 
at: European Society for Blood and Marrow Transplantation; 22-25 March, 2015; 
Istanbul, Turkey.
12.
Abel GA, Albelda R, Salas Coronado D, Marcellot L. Exploring the relationship of 
employment benefits to the financial burden and health outcomes of certain blood cancer 
patients (abstract). Paper presented at: Labor and Employment Relations Association 
Annual Meeting; January, 2015.
13.
Warttig SL, Forshaw MJ, South J, White AK. New, normative, English-sample data for 
the Short Form Perceived Stress Scale (PSS-4). Journal of health psychology. Dec 
2013;18(12):1617-1628.
14.
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of 
health and social behavior. Dec 1983;24(4):385-396.

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15.
Cohen S, Williamson G. Perceived Stress in a Probability Sample of the United States. 
In: Spacapan S, Oskamp S, eds. The Social Psychology of Health. Newbury Park, Calif.: 
Sage Publications; 1988.
16.
Majhail NS, Rizzo JD. Surviving the cure: long term followup of hematopoietic cell 
transplant recipients. Bone marrow transplantation. Sep 2013;48(9):1145-1151.
17.
Oeffinger KC, McCabe MS. Models for delivering survivorship care. J Clin Oncol. Nov 
10 2006;24(32):5117-5124.
18.
Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD 
Grading. Bone marrow transplantation. Jun 1995;15(6):825-828.
19.
Bevans MF, Marden S, Leidy NK, et al. Health-related quality of life in patients 
receiving reduced-intensity conditioning allogeneic hematopoietic stem cell 
transplantation. Bone marrow transplantation. Jul 2006;38(2):101-109.
20.
Kim HT. Cumulative incidence in competing risks data and competing risks regression 
analysis. Clinical cancer research : an official journal of the American Association for 
Cancer Research. Jan 15 2007;13(2 Pt 1):559-565.
21.
Kim HT, Armand P. Clinical endpoints in allogeneic hematopoietic stem cell 
transplantation studies: the cost of freedom. Biology of blood and marrow 
transplantation : journal of the American Society for Blood and Marrow Transplantation. 
Jun 2013;19(6):860-866.

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Usual Care:

You will receive all follow-up 
care at DFCI only. This does not 
mean you must only come to 
Dana-Farber when you are sick; 
if you cannot travel to Boston, 
please seek care locally. 

You will be asked to fill out 
quality of life surveys 
periodically throughout the 180 
days.
8.0 APPENDICES
A. Patient Enrollment Information Sheet
Research Study Brief Information Sheet: 
Shared Care vs. Usual Care 
There is an ongoing study at the Dana-Farber Cancer Institute (DFCI) investigating the 
effectiveness of a shared model of care following a hematopoietic cell transplantation (HCT) 
compared to the effectiveness of usual care. Patients in the Shared Care model receive half of 
their scheduled follow-up appointments at a local site and the other half at Dana-Farber. Usual 
Care patients receive all scheduled follow-up appointments at Dana-Farber. This study is being 
sponsored by the Patient-Centered Outcomes Research Institute (PCORI).
If you are eligible for this study you will be asked to consider participating at your tranplsant 
consent session. If you agree, you will be randomized into either Shared Care or Usual Care. 
You would have an equal chance of being placed into either model. 
Shared Care:

You will receive half your care at DFCI and half 
at a local oncologist. The local oncologist may 
or may not have been the physician who referred 
you to transplant. This oncologist will have 
received training at DFCI specifically in post-
transplant care. 

For the first 90 days post-transplant, you will 
alternate between your local oncologist and 
DFCI for weekly visits.

From 90-180 days, you will alternate between 
your local oncologist and DFCI every 2-3 weeks, 
depending on your specific case.

Your physicians will coordinate your care using 
a web-based program called ACT.md. You may 
use this website to keep track of appointments 
and view your care plan.

You will be asked to fill out quality of life 
surveys periodically throughout the 180 days.
OR
If you have any questions about this study, please contact Research Assistant Priya Marathe at 617-632-5766 
or priya_marathe@dfci.harvard.edu. 

Shared Care after HCT 22
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B. Short Form (SF) Post-HCT Financial Assessment
1. Including yourself, how many adults 18 years or older currently live in your household?
Write in number of adult(s): ________
 
2.   How many children under 18 years old currently live in your household?
Write in number of children: ________
3.   What is the highest level grade or level of school that you have completed?
 8th grade or less
 Some high school, but did not graduate
 High school graduate or GED
 Some college or Associate degree
 Bachelor degree
 Graduate degree
4.   Do you consider yourself Hispanic or Latino?
 Yes, Hispanic or Latino
 No, not Hispanic or Latino
5.   What is your race? Please mark one or more. 
 White
 Black or African-American 
 Asian 
 Native Hawaiian or Pacific Islander
 American Indian or Alaskan Native
 More than one race
6.   What is your current marital status?
 Married
 Widowed
 Divorced 
About You

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 Separated
 Never married
7.   What is your current employment status?
 Not employed (including retired, student or homemaker)
 Unemployed and looking for work 
 Taking a leave of absence, but still have a job
 Working full or part-time (if self-employed, also check here 
)
8.   What is your current occupation, or if not currently working, what was your last job for 
pay?
 Please specify occupation: _______________________________
Employment
         
       
9.
In the week of your transplant, what was your employment status?
 
 Not employed (including retired, student or homemaker) If not employed, go to #17
 
 Unemployed and looking for work  If unemployed, go to #17
 
 Taking a leave of absence or time off, but still had a job
 
 Working full or part-time (if self-employed, also check here 
)
10. What was your job for pay during the week of your transplant? 
  Please specify occupation: _______________________________
11.   What was your monthly income from employment at that time? 
          
 Less than $1,000 
          
 $1,000 to $2,999
          
 $3,000 to $4,999
          
 $5,000 to $6,999
          
 $7,000 or more 
12.
Since your transplant, how supportive has your employer been about you returning to 
work? 
Please circle one. 
13.
Since your transplant, were you able to use family and medical leave (FMLA) provided 
Unsupportive
Completely 
Supportive 
Not 
Applicable
1
2
3
4
5 
NA

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through 
your employer? 
 
 Yes 
 
 No, not offered by employer
 
 No, did not need it
    
 No, self-employed or not employed
14.
Since your transplant, have you used any of the following? Please mark yes or no for each. 
 Vacation time..........................................................................................
 Yes    
 
No
 Employer paid sick days or paid medical leave.......................................
 Yes    
 
No     
 Personally purchased or employer-sponsored disability insurance..........
 Yes    
 
No
 Unpaid time off................................................................................
 Yes    
 
No     
15.
Since your transplant, about how much total time have you taken off from work? 
 Write in number of weeks:  _____________   
16.
Since your transplant, how much of the time you took off was paid time off? 
 
 None 
 
 Less than half
 
 About half
 
 More than half
 
 All
Current Household Finances
17. In general, how satisfied are you with your family’s present financial situation? Please 
circle one. 
Not satisfied at all
Completely satisfied 
1
2
3
4
5
18. How difficult is it for you/your family to meet monthly payments on your bills? Please 
circle one.
Not difficult at all
Extremely difficult
1
2
3
4
5
19.
How do your family’s finances usually work out at the end of the month? 

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 Some money left over
 
 Just enough money
 
 Not enough money
20.
Compared to before your transplant, how has your monthly household income changed?
 
 It has decreased
 
 It is about the same
 
 It has increased
21.
The following questions ask about things people do when money is tight. Since your 
transplant, how often did you or your family have to do any of the following? Please circle 
one.
Never
Rarely
Sometimes
Often
Reduce spending on essential household expenses 
(food, clothing, rent/mortgage)?............................
1
2
3
4
Withdraw from retirement or savings accounts?...
1
2
3
4
Borrow money to help pay for bills?.....................
1
2
3
4
Reduce leisure activities?.......................................
1
2
3
4
Cut back on prescribed medications?.....................
1
2
3
4
22. Since your transplant, have you received any of the following resources to help cover 
expenses? Please check all that apply. 
        
 Social Security Disability Insurance or Social Security Insurance 
 
 Government assistance programs (food stamps, fuel or cash assistance)
 
 Dana-Farber financial assistance (discount hotel rooms, gas or food gift cards)
 
 Local or national charities (churches/synagogues, American Cancer Society) 
 
 None of the above
23.
What is your current monthly household income (include income from all household 
members)?
 
 Less than $1,000 
 
 $1,000 to $2,999 
 
 $3,000 to $4,999 
       
 $5,000 to $6,999 
 
 $7,000 or more 
Health Insurance and Medical Costs

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24.
How satisfied are you with your current insurance coverage? Please circle one. 
Not satisfied at All
Completely satisfied 
1
2
3
4
5
25.
About how much of your own money did you spend last month for your medical care 
(including prescriptions, co-payments, deductibles, and premiums)? 
   $_________________________dollars per month
26.
The next questions are about costs associated with your transplant that are not direct 
medical 
costs. Since your transplant, how difficult has it been for you to pay for the 
following costs? Please circle one number or “N/A” if you did not have the type of cost 
after your transplant. 
27.
How difficult is it for you to pay your medical bills (including prescriptions, co-payments, 
premiums, and deductibles)? Please circle one.
Not difficult at all
Extremely difficult
1
2
3
4
5
28.
The following questions ask about things that may make your life more difficult or 
stressful.    
Not at all 
difficult
Extremely 
difficult
Not 
Applicable
Paying to temporarily relocate 
closer to transplant center...............
1
2
3
4
5
N/A
Paying for transportation to and 
from your appointments (gas, 
parking)...........................................
1
2
3
4
5
N/A
Paying for transplant-related 
changes at home (cleaning, 
special foods)..................................
1
2
3
4
5
N/A
Paying for care services for 
children or parents usually in my 
care..................................................
1
2
3
4
5
N/A

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During the last month, how much have each of the following added stress in your life?
Not at all 
A lot
Worry about being a burden on your family…
1
2
3
4
Worry about not having money for necessities 
like food, utilities, and housing……………….
1
2
3
4
Worry about losing or not having health 
insurance……………………………………...
1
2
3
4
Worry about cost of your health insurance.......
1
2
3
4
Worry about paying medical bills…………….
1
2
3
4
29.
Thinking back to before your transplant, how informed do you feel you were about post-
transplant related costs? 
 
 Not at all informed 
 
 Somewhat informed
 
 Extremely informed  
30.
Who gave you information about post-transplant related costs? (Check all that apply)  
 
 Doctor 
 
 Nurse
 
 Social worker
 
 Resource specialist
 
 Someone else  Who? _________________
 
 No one

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C. Caregiver Quality of Life – Adapted Patient Survey
100 days post transplant:
Which of the following statements best describes your relationship with your primary caregiver? 

My caregiver is a family member.

My caregiver is a friend.

My caregiver is a paid professional.

My caregiver is other______________________________
Below is a list of statements that people caring for loved ones with cancer have said are important. By circling one 
number per line, please indicate how true each statement has been for you during the past 7 days. 
0 = Not at all
1 = A little bit 2 = Somewhat 3 = Quite a bit 4 = Very much
My caregiver seems…
1. …supported by friends and neighbors
0
1
2
3
4
2. …to have adequate information about my care
0
1
2
3
4
3. …to have a new daily routine since my transplant
0
1
2
3
4
4. …more tired than before my transplant
0
1
2
3
4
5. …more stressed than before my transplant
0
1
2
3
4
I feel that… 
6. …my caregiver is part of my decision-making team 
regarding my transplant
0
1
2
3
4
7. …my caregiver and I have developed a closer 
relationship since transplant
0
1
2
3
4
8. …the transplant process has negatively impacted 
my relationship with my caregiver
0
1
2
3
4
9. …I am dependent on my caregiver for 
transportation
0
1
2
3
4
10. …my caregiver takes primary responsibility for my 
diet 
0
1
2
3
4
Circle the answer below that bests describes the employment situation of your caregiver:  
My caregiver…
a.
was not working before and is not working now
b. was not working before and is working now
c.
was working before and is not working now
d. was working before and is working now

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180 days post transplant:
Has your primary caregiver changed since you last filled out this survey (at 100 days post-transplant)? 

Yes, I have a different caregiver.

No, my caregiver has remained the same.

I do not remember.
Which of the following statements best describes your relationship with your primary caregiver? 

My caregiver is a family member.

My caregiver is a friend.

My caregiver is a paid professional.

My caregiver is other______________________________
Below is a list of statements that people caring for loved ones with cancer have said are important. By circling one 
number per line, please indicate how true each statement has been for you during the past 7 days. 
0 = Not at all
1 = A little bit 2 = Somewhat 3 = Quite a bit 4 = Very much
My caregiver seems…
1.…supported by friends and neighbors
0
1
2
3
4
2…to have adequate information about my care
0
1
2
3
4
3…to have a new daily routine since my transplant
0
1
2
3
4
4…more tired than before my transplant
0
1
2
3
4
5…more stressed than before my transplant
0
1
2
3
4
I feel that… 
6…my caregiver is part of my decision-making team 
regarding my transplant
0
1
2
3
4
7…my caregiver and I have developed a closer 
relationship since transplant
0
1
2
3
4
8…the transplant process has negatively impacted my 
relationship with my caregiver
0
1
2
3
4
9…I am dependent on my caregiver for transportation
0
1
2
3
4
10…my caregiver takes primary responsibility for my 
diet 
0
1
2
3
4
Circle the answer below that bests describes the employment situation of your caregiver:  
My caregiver…
a.
was not working before and is not working now
b. was not working before and is working now
c.
was working before and is not working now
d. was working before and is working now

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D. European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)

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E. FACT-BMT

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F. Sample Post-HCT Care Coordination Plan
John Smith’s Post-HCT Care Coordination Plan
Dana-Farber Cancer Institute and New York Oncology Hematology
DFCI HCT Team
NYOH Team
Vincent Ho, MD.
Mobile:  (617) 123-4567
Office:    (617) 123-7890
Ira Zackon, MD.
Mobile:  (518) 123-4567
Office:    (518) 123-7890
Amy Joyce, NP.
Mobile:  (617) 123-4567
Office:    (617) 123-7890
Jane Smith, NP.
Mobile:  (518) 123-4567
Office:    (518) 123-7890
Background
John is a patient at Dana Farber's Hematologic Oncology unit. He was diagnosed with Non-Hodgkin 
lymphoma in early 2013. He has undergone an HCT on November 1, 2016- post 10 wks of 
chemotherapy. He will be a part of the Shared Care program as he recovers from the transplant.
Post Transplant Information 
Primary Malignancy: Non-Hodgkin’s 
Lymphoma
Date of transplant (Day 0): 11/1/2016
Disease status at transplant: Stable
Remission status at transplant: Stable
Blood Type
CMV Status
Type of transplant: URD
Recipient
Donor
Recipient
Donor
Protocol/Treatment Plan: 924 - Flu/Bu
O+
O-
NEGATIVE
NEGATIVE

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G. ACT.md Education Screenshot 

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H. Draft of Local Provider Education Curriculum 
Dana-Farber Cancer Institute Transplant Education Program for
PCORI Partners, Shared Care Partners, and all other payers and providers
Friday: 
Schedule
7:30-8:00
Breakfast
8:00-10:00
Rounding on BMT A, BMT B, HM PA                       
8:00-10:00
Clinic shadowing
10:00-10:30
Break
10:30-11:00
Introduction
11:00-11:30
Pre-transplant process and donor management
11:30-12:00
Inpatient Care
12:00-1:00
Lunch
1:00-1:30
Graft-versus-host-disease
1:30-2:30
Infectious disease
2:30-3:00
Post-Auto HSCT Follow-up
3:00-3:30
Post-Allo HSCT Follow-up
3:30-3:45
Break
3:45-4:15
Immuno Effector Cell Therapy
4:15-4:45
Relapse and Survivorship
Saturday morning: 
Schedule
7:30-8:00
Breakfast
8:00-10:00
Rounding on BMT A, BMT B, HM PA
10:00-10:30
Break
10:30-11:30
Shared Care Model
11:30-12:30
Case studies and discussion
12:30-1:30
Lunch
Saturday afternoon: 
Schedule
1:30-2:30
PCORI Overview
2:30-4:30
Act.md
Sunday: 
Schedule
7:30-8:00
Breakfast
8:00-10:00
Rounding on BMT A, BMT B, HM PA
PCORI Shared Care PIs only
9:30-10:00
DFCI tour
PCORI SC-PAP and Stakeholders
10:00-10:30
Break
10:30-11:00
Welcome and introductions
11:00-12:30
Integrating PCORI into your hospital
PCORI Shared Care PIs
11:00-12:30
Patient engagement
SC-PAP
11:00-12:30
Stakeholder engagement
PCORI Shared Care Stakeholders
12:30-1:30
Lunch
1:30-2:30
Reporting for PCORI
PCORI Shared Care PIs
1:30-2:30
Future goals
SC-PAP and Stakeholders
2:30-3:30
Close of session

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I. ACT.md Communication Screenshot

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J. Multi-Center Data and Safety Monitoring Plan (DSMP) 
TABLE OF CONTENTS
1.0
INTRODUCTION............................................................................................................................3
1.1 OVERVIEW.......................................................................................................................................3
1.2 BACKGROUND AND RATIONALE...............................................................................................4
2.0 OBJECTIVES.........................................................................................................................................5
3.0 RESEARCH SUBJECT SELECTION...................................................................................................6
4.0 RESEARCH SUBJECT ENTRY ...........................................................................................................7
5.0 STUDY DESIGNS AND METHODS ...................................................................................................7
5.1 DESIGN/ STUDY TYPE ...................................................................................................................7
5.2 SELECTION OF INSTRUMENTS....................................................................................................7
5.3 DESCRIPTION OF INTERVENTION..............................................................................................8
5.4 DATA COLLECTION.......................................................................................................................8
5.5 DESCRIPTION OF STUDY PROCESS............................................................................................9
5.51 Instrument Administration..........................................................................................................10
5.52 Intervention Administration........................................................................................................11
5.53 Compensation .............................................................................................................................12
5.6 ADVERSE REACTION AND THEIR MANAGEMENT...............................................................12
5.61 Reporting Adverse or Unanticipated Events...............................................................................13
6.0 STATISTICAL ANALYSIS ................................................................................................................13
6.2 PATIENT-REPORTED OUTCOMES (POWERED ON FACT-BMT) ..........................................15
6.3 HANDLING OF MISSING DATA..................................................................................................15
7.0 REFERENCES.....................................................................................................................................19
8.0 APPENDICES......................................................................................................................................21
A. Patient Enrollment Information Sheet................................................................................................21
B. Short Form (SF) Post-HCT Financial Assessment.............................................................................22
C. Caregiver Quality of Life – Adapted Patient Survey .........................................................................28
D. European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) .......................30
E. FACT-BMT .......................................................................................................................................32
F. Sample Post-HCT Care Coordination Plan ........................................................................................37
G. ACT.md Education Screenshot..........................................................................................................38
H. Draft of Local Provider Education Curriculum .................................................................................39
I. ACT.md Communication Screenshot..................................................................................................40
J. Multi-Center Data and Safety Monitoring Plan (DSMP)....................................................................41

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INTRODUCTION......................................................................................................................................43
Purpose ...................................................................................................................................................43
Multi-Center Data and Safety Monitoring Plan Definitions...................................................................43
GENERAL ROLES AND RESPONSIBILITIES ......................................................................................44
DF/HCC Sponsor....................................................................................................................................44
Coordinating Center ...............................................................................................................................45
Participating Institution ..........................................................................................................................45
DF/HCC REQUIREMENTS FOR MULTI-CENTER PROTOCOLS.......................................................46
Protocol Distribution ..............................................................................................................................46
Protocol Revisions and Closures ............................................................................................................46
Informed Consent Requirements ............................................................................................................47
IRB Documentation................................................................................................................................47
IRB Re-Approval....................................................................................................................................47
Participant Confidentiality and Authorization Statement .......................................................................47
DF/HCC Multi-Center Protocol Registration Policy..............................................................................48
DF/HCC Protocol Case Number ............................................................................................................49
Safety Assessments and Toxicity Monitoring ........................................................................................50
Data Management...................................................................................................................................51
MONITORING: QUALITY CONTROL...................................................................................................51
Ongoing Monitoring of Protocol Compliance ........................................................................................51
Monitoring Reports.................................................................................................................................52
Accrual Monitoring ................................................................................................................................52
AUDITING: QUALITY ASSURANCE ....................................................................................................53
DF/HCC Internal Audits.........................................................................................................................53
Audit Notifications .................................................................................................................................53
Audit Reports..........................................................................................................................................53
Participating Institution Performance .....................................................................................................53
K. Shared Care Patient Schedule (Example) ..........................................................................................55

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INTRODUCTION
The Dana-Farber/Harvard Cancer Center Multi-Center Data and Safety Monitoring Plan 
(DF/HCC DSMP) outlines the procedures for conducting a DF/HCC Multi-Center research 
protocol. The DF/HCC DSMP serves as a reference for any sites external to DF/HCC that 
are participating in a DF/HCC clinical trial.
Purpose
To establish standards that will ensure that a Dana-Farber/Harvard Cancer Center Multi-
Center protocol will comply with Federal Regulations, Health Insurance Portability and 
Accountability Act (HIPAA) requirements and applicable DF/HCC Standard Operating 
Procedures.       
Multi-Center Data and Safety Monitoring Plan Definitions
DF/HCC Multi-Center Protocol:  A research protocol in which one  or more outside 
institutions are collaborating with Dana-Farber/Harvard Cancer Center where  a DF/HCC 
investigator is the sponsor. DF/HCC includes Dana-Farber/Partners Cancer Care (DF/PCC) 
Network Clinical Trial Affiliates. 
Lead Institution:  One of the Dana-Farber/Harvard Cancer Center consortium members 
(Dana-Farber Cancer Institute (DFCI), Massachusetts General Hospital (MGH), Beth Israel 
Deaconess Medical Center (BIDMC), Boston Children’s Hospital (BCH), Brigham and 
Women’s Hospital (BWH) responsible for the coordination, development, submission, and 
approval of a protocol as well as its subsequent amendments per the DFCI IRB and 
applicable regulatory guidelines (CTEP, Food and Drug Administration (FDA), Office of 
Biotechnology Activities (OBA) etc.).  The Lead Institution is typically the home of the 
DF/HCC Sponsor. The Lead Institution also typically serves as the Coordinating Center for 
the DF/HCC Multi-Center Protocol.  
DF/HCC Sponsor:  The person sponsoring the submitted Multi-Center protocol who takes 
responsibility for initiation, management and conduct of the protocol at all research 
locations. In applicable protocols, the DF/HCC Sponsor will serve as the single liaison with 
any regulatory agencies. The DF/HCC Sponsor has ultimate authority over the protocol and 
is responsible for the conduct of the study at DF/HCC and all Participating Institutions. In 
most cases the DF/HCC Sponsor is the same person as the DF/HCC Overall Principal 
Investigator; however, both roles can be filled by two different people. 
Participating Institution:  An institution that is outside the DF/HCC and DF/PCC 
consortium that is collaborating with DF/HCC on a protocol where the sponsor is a DF/HCC 
Investigator.  The Participating Institution acknowledges the DF/HCC Sponsor as having 
the ultimate authority and responsibility for the overall conduct of the study.   
Coordinating Center: The entity (i.e. Lead Institution, Medical Monitor, Contract 
Research Organization (CRO), etc) that provides administrative support to the DF/HCC 
Sponsor in order that he/she may fulfill the responsibilities outlined in the protocol 

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document and DSMP, and as specified in applicable regulatory guidelines (i.e. CTEP Multi-
Center Guidelines). In general, the Lead Institution is the Coordinating Center for the 
DF/HCC Multi-Center Protocol. 
DF/HCC Office of Data Quality (ODQ): A group within DF/HCC responsible ensuring 
high-quality standards are used for data collection and the ongoing management of clinical 
trials, auditing, and data and safety monitoring. ODQ also coordinates quality assurance 
efforts related to multi-center clinical research.
DF/HCC Clinical Trials Research Informatics Office (CTRIO): A group within 
DF/HCC responsible for providing a comprehensive data management platform for 
managing clinical trial data.
GENERAL ROLES AND RESPONSIBILITIES
For DF/HCC Multi-Center Protocols, the DF/HCC Sponsor, the Coordinating Center, and 
the Participating Institutions are expected to adhere to the following general responsibilities: 
DF/HCC Sponsor
The DF/HCC Sponsor, Patient-Centered Outcomes Research (PCORI) will accept 
responsibility for all aspects of conducting a DF/HCC Multi-Center protocol which includes 
but is not limited to: 

Oversee the coordination, development, submission, and approval of the protocol as 
well as subsequent amendments. 

Ensure that the investigators, study team members, and Participating Institutions are 
qualified and appropriately resourced to conduct the protocol.  

Include the Multi-Center Data and Safety Monitoring Plan as an appendix to the 
protocol.

Ensure all Participating Institutions are using the correct version of the protocol.

Ensure that each participating investigator and study team member receives 
adequate protocol training (and/or a Site Initiation Visit prior to enrolling 
participants) and throughout trial’s conduct as needed.

Ensure the protocol will be provided to each participating site in a language 
understandable to all applicable site personnel when English is not the primary 
language. 

Monitor progress and overall conduct of the study at all Participating Institutions. 

Ensure all DFCI Institutional Review Board (IRB) and DF/HCC reporting 
requirements are met. 

Review data and maintain timely submission of data for study analysis. 

Ensure compliance with all requirements as set forth in the Code of Federal 
Regulations, applicable DF/HCC requirements, HIPAA requirements, and the 
approved protocol.

Commit to the provision that the protocol will not be rewritten or modified by 
anyone other than the DF/HCC Sponsor.

Identify and qualify Participating Institutions and obtain accrual commitments prior 
to extending the protocol to that site.

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
Monitor accrual and address Participating Institutions that are not meeting their 
accrual requirements. 
Coordinating Center 
The general responsibilities of the Coordinating Center, DFCI, may include but are not 
limited to:

Assist in protocol development. 

Review registration materials for eligibility and register participants from 
Participating Institutions in the DF/HCC clinical trial management system 
(OnCore).

Distribute protocol and informed consent document updates to Participating 
Institutions as needed.

Oversee the data collection process from Participating Institutions.

Maintain documentation of Serious Adverse Event (SAE) reports and 
deviations/violation submitted by Participating Institutions and provide to the 
DF/HCC Sponsor for timely review and submission to the DFCI IRB, as 
necessary. 

Distribute serious adverse events reported to the DF/HCC Sponsor that fall under 
the DFCI IRB Adverse Event Reporting Policy to all Participating Institutions.

Provide Participating Institutions with information regarding DF/HCC requirements 
that they will be expected to comply with.

Carry out plan to monitor Participating Institutions either by on-site or remote 
monitoring. 

Maintain Regulatory documents of all Participating Institutions which includes but 
is not limited to the following: local IRB approvals/notifications from all 
Participating Institutions, confirmation of Federalwide Assurances (FWAs) for all 
sites,  all SAE submissions, Screening Logs for all sites, IRB approved consents 
for all sites

Conduct regular communications with all Participating Institutions (monthly 
conference calls web-based communication platform) and maintain documentation 
all relevant communications.
Participating Institution
Each Participating Institution is expected to comply with all applicable federal regulations 
and DF/HCC requirements, the protocol and HIPAA requirements. 
The general responsibilities for each Participating Institution may include but are not limited 
to:

Document the delegation of research specific activities to study personnel.

Commit to the accrual of participants to the protocol.

Submit protocol and/or amendments to their local IRB.

Maintain regulatory files as per sponsor requirements.

Provide the Coordinating Center with regulatory documents or source documents as 

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requested.

Participate in protocol training prior to enrolling participants and throughout the trial 
as required (in-person training conference at DFCI).

Update Coordinating Center with research staff changes on a timely basis.

Register participants through the Coordinating Center prior to beginning research 
related activities. 

Submit Serious Adverse Event (SAE) reports to local IRB per institutional 
requirements and to the Coordinating Center, in accordance with DF/HCC 
requirements. 

Submit protocol deviations and violations to local IRB per institutional requirements 
and to the DF/HCC Sponsor in accordance with DF/HCC requirements.

Order, store and dispense investigational agents and/or other protocol mandated 
drugs per federal guidelines and protocol requirements.

Have office space, office equipment, and internet access that meet HIPAA standards.

Participate in any quality assurance activities and meet with monitors or auditors at 
the conclusion of a visit to review findings.

Promptly provide follow-up and/or corrective action plans for any monitoring 
queries or audit findings.
DF/HCC REQUIREMENTS FOR MULTI-CENTER PROTOCOLS
The following section will clarify DF/HCC Requirements and further detail the expectations 
for participating in a DF/HCC Multi-Center protocol. 
Protocol Distribution
The Coordinating Center will distribute the final DFCI IRB approved protocol and any 
subsequent amended protocols to all Participating Institutions.   
Protocol Revisions and Closures
The Participating Institutions will receive notification of protocol revisions and closures 
from the Coordinating Center.  It is the individual Participating Institution’s responsibility 
to notify its IRB of these revisions.

Non life-threatening revisions: Participating Institutions will receive written 
notification of protocol revisions regarding non life-threatening events from the 
Coordinating Center. Non-life-threatening protocol revisions must be IRB approved 
and implemented within 90 days from receipt of the notification.

Revisions for life-threatening causes: Participating Institutions will receive 
immediate notification from the Coordinating Center concerning protocol revisions 
required to protect lives with follow-up by fax, mail, e-mail, etc.  Life-threatening 
protocol revisions will be implemented immediately followed by IRB request for 
approval.

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
Protocol closures and temporary holds: Participating Institutions will receive 
notification of protocol closures and temporary holds from the Coordinating Center. 
Closures and holds will be effective immediately.  In addition, the Coordinating 
Center, will update the Participating Institutions on an ongoing basis about protocol 
accrual data so that they will be aware of imminent protocol closures.
Informed Consent Requirements
The DF/HCC approved informed consent document will be the sole consent form for the 
entire study. Participants in this study are consenting to receive half their care at DFCI and 
half at a Participating Institution; therefore, all participants will be consented at DFCI. 
Though a Participating Institution may recommend potential participants, all recruitment 
will take place at DFCI, the Lead Institution. This consent form will follow the consent 
template and will adhere to specifications outlined in the DF/HCC Guidance Document on 
Model Consent Language for PI-Initiated Multi-Center Protocols.  This document will be 
provided separately to each Participating Institution upon request.
The DFCI research team will submit the consent forms to the IRB for approval.
Participating institutions must follow the DF/HCC requirement that all  informed consent 
and re-consent for all research will take place at DFCI.
IRB Documentation
The following must be on file with the Coordinating Center:

Initial approval letter of the Participating Institution's IRB. 

Copy of the DFCI Informed Consent Form 

Participating Institution’s IRB approval for all amendments.

Annual approval letters by the Participating Institution's IRB.
IRB Re-Approval
Verification of IRB re-approval from the Participating Institutions is required in order to 
continue research activities.  There is no grace period for continuing approvals.
The Coordinating Center. DFCI, will not register participants to receive half their care at a 
Participating Institution if a re-approval letter is not received from the Participating 
Institution on or before the anniversary of the previous approval date.  
Participant Confidentiality and Authorization Statement
In 1996, congress passed the first federal law covering the privacy of health information 
known as the Health Insurance Portability and Accountability Act (HIPPA). Any 
information, related to the physical or mental health of an individual is called Protected 
Health Information (PHI). HIPAA outlines how and under what circumstances PHI can be 
used or disclosed. 

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In order for covered entities to use or disclose protected health information during the course 
of a study, the study participant must sign an authorization statement.  This authorization 
statement may or may not be separate from the informed consent document.  The 
Coordinating Center, with the approval from the DFCI IRB, will provide a consent template, 
with information regarding authorization for the disclosure of protected health information. 
The DF/HCC Sponsor, PCORI, will use all efforts to limit its use of protected health 
information in its trials. However, because of the nature of these trials, certain protected 
health information must be collected. DF/HCC has chosen to use authorizations, signed by 
the participant in the trial, rather than limited data sets with data use agreements.
 DF/HCC Multi-Center Protocol Confidentiality
All documents, investigative reports, or information relating to the participant are strictly 
confidential. Whenever reasonably feasible, any participant specific reports (i.e. Pathology 
Reports, MRI Reports, Operative Reports, etc.) submitted to the Coordinating Center should 
be de-identified. It is recommended that the assigned protocol case number (as described 
below) be used for all participant specific documents. Participant initials may be included 
or retained for cross verification of identification. 
DF/HCC Multi-Center Protocol Registration Policy
All registration will take place at the Coordinating Center, DFCI.
 Participant Registration and Randomization 
To register a participant, the following documents should be completed by the 
Coordinating Center:

Signed informed consent document

Protocol Registration Form
To complete the registration process, the Coordinating Center will:

Register the participant on the study with the DF/HCC Clinical Trial Management 
System (OnCore).

Upon receiving confirmation of registration, the Coordinating Center will inform 
the Participating Institution, provide the study specific participant case number, and 
begin coordinating care per the protocol and study design. 
Treatment may not begin without confirmation from the Coordinating Center 
that the participant has been registered. 
Randomization can only occur during normal business hours, Monday through Friday from 
8:00 AM to 5:00 PM Eastern Standard Time.
 Initiation of Therapy

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Participants must be registered with the DF/HCC OnCore before the initiation protocol-
specific interventions. The protocol-specific interventions may not be initiated until the 
Participating Institution receives confirmation of the participant’s registration from the 
Coordinating Center. The DF/HCC Sponsor and DFCI IRB must be notified of any 
violations to this policy.
 Eligibility Exceptions
No exceptions to the eligibility requirements for a protocol without DFCI IRB approval will 
be permitted. The process for requesting an eligibility exception is defined below.
DF/HCC Protocol Case Number
At the time of registration, the following identifiers are required for all subjects: initials, 
date of birth, gender, race and ethnicity. Once eligibility has been established and the 
participant successfully registered, the participant is assigned a unique protocol case 
number.  This information will be recorded at the Coordinating Center.
Protocol Deviations, Exceptions and Violations
Federal Regulations require an IRB to review proposed changes in a research activity to 
ensure that researchers do not initiate changes in approved research without IRB review 
and approval, except when necessary to eliminate apparent immediate hazards to the 
participant. DF/HCC requires all departures from the defined procedures set forth in the 
IRB approved protocol to be reported to the DF/HCC Sponsor, PCORI, who in turn is 
responsible for reporting to the DFCI IRB.
For reporting purposes, DF/HCC uses the terms “violation”, “deviation” and “exception” 
to describe departures from a protocol. All Participating Institutions must adhere to these 
requirements for reporting to the DF/HCC Sponsor and will follow their institutional policy 
for reporting to their local IRB.
 Definitions
Protocol Deviation: Any departure from the defined procedures set forth in the IRB-
approved protocol which is prospectively approved prior to its implementation.
Protocol Exception:  Any protocol deviation that relates to the eligibility criteria, e.g.
enrollment of a participant who does not meet all inclusion/exclusion criteria.
Protocol Violation: Any protocol departure that was not prospectively approved by the IRB 
prior to its initiation or implementation. 
 Reporting Procedures
DF/HCC Sponsor: is responsible for ensuring that clear documentation is available in the 
medical record and/or regulatory documents to describe all protocol exceptions, deviations 

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and violations. The DF/HCC Sponsor will also be responsible for ensuring that all protocol 
violations/deviations are promptly reported per DFCI IRB guidelines. 
Participating Institutions: Protocol deviations require prospective approval from the DFCI 
IRB. The Participating Institution must submit the deviation request to the Coordinating 
Center who will then submit the deviation request to the DFCI IRB. Upon DFCI IRB 
approval the deviation is submitted to the Participating Institution IRB, per institutional 
policy. A copy of the Participating Institution’s IRB report and determination will be 
forwarded to the Coordinating Center within 10 business days after the original submission.  
The deviation may not be implemented without all required approvals.
All protocol violations must be sent to the Coordinating Center in a timely manner. The 
Coordinating Center will provide training for the requirements for the reporting of 
violations. 
Coordinating Center:  Upon receipt of the violation/deviation report from the Participating 
Institution, the Coordinating Center will submit the report to the DF/HCC Sponsor for 
review. Subsequently, the Participating Institution’s IRB violation/deviation report will be 
submitted to the DFCI IRB for review per DFCI IRB reporting guidelines. DF/HCC will 
forward all violation reports to CTEP via an internal DF/HCC process, as applicable.
Safety Assessments and Toxicity Monitoring
The study teams at all participating institutions are responsible for protecting the safety, 
rights and well-being of study participants. Recording and reporting of adverse events that 
occur during the course of a study help ensure the continuing safety of study participants. 
All participants receiving protocol mandated  care plan will be evaluated for safety. The 
safety parameters include all laboratory tests and hematological abnormalities, physical 
examination findings, and spontaneous reports of adverse events reported by participants.  
All toxicities encountered during the study will be evaluated according to the NCI criteria 
specified in the protocol. Life-threatening toxicities must be reported immediately to the 
DF/HCC Sponsor via the Coordinating Center. 
Additional safety assessments and toxicity monitoring will be outlined in the protocol.
Guidelines for Reporting Serious Adverse Events 
Guidelines for reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) are 
detailed in protocol section 5.6.
Participating Institutions must report the SAEs to the DF/HCC Sponsor and the 
Coordinating Center following the DFCI IRB Adverse Event Reporting Policy. 
The Coordinating Center will maintain documentation of all Participating Institution 
Adverse Event reports and be responsible for communicating to all participating 
investigators, any observations reportable under the DFCI IRB Reporting Requirements.  

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Participating Institutions will review and submit to their IRB according to their institutional 
policies and procedures
Guidelines for Processing IND Safety Reports 
The DF/HCC Sponsor will review all IND Safety Reports and ensure that all IND Safety 
Reports are distributed to the Participating Institutions. Participating Institutions will 
review/submit to their IRB according to their institutional policies and procedures.
Data Management
Guidelines for data collection and management are detailed in section 5.4 All patients will 
be registered in OnCore.
Data Forms Review
Data submissions are monitored for timeliness and completeness of submission. If study 
forms are received with missing or questionable data, the submitting institution will receive 
a written or electronic query from the DF/HCC Office of Data Quality or designee. 
Responses to all queries should be completed and submitted within 14 calendar days.  
Responses may be returned on the written query or on an amended paper case report form, 
or in the case of electronic queries, within the electronic data capture (eDC) system. In the 
case of a written query for data submitted on a paper case report form, the query must be 
attached to the specific data being re-submitted in response.  
If study forms are not submitted on schedule, the Participating Institution will periodically 
receive a Missing Form Report from the Coordinating Center noting the missing forms. 
MONITORING: QUALITY CONTROL
The quality control process for a clinical trial requires verification of protocol compliance 
and data accuracy. The Coordinating Center, with the aid of the DF/HCC Office of Data 
Quality, provides quality control oversight for the protocol.
Ongoing Monitoring of Protocol Compliance
 
Meetings will be held at least twice each year, which will mean at least eight reviews during 
the proposed Shared Care study period. Each protocol is discussed in both an open and a 
closed session. In the open session, members of the study team, including the study 
statistician Dr. Kim and the PI, Dr. Abel, may be present to review the conduct of the trial 
and to answer questions from members of the DSMB. The focus of this open session will 

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be on accrual, protocol compliance, and general toxicity issues. Outcomes will normally not 
be discussed during the open session. The closed session of the DSMB will include only the 
voting, non-voting, and ad hoc members, and will include discussion of the general conduct 
of the trial and outcomes, including non-relapsed mortality. The study statistician may be 
asked to present outcome data during the closed session. 
The DSMB will review interim analyses of outcomes (prepared by the lead statistician) and 
make recommendations as to whether the study needs to be continued, changed or 
terminated. Site adverse event reports will be submitted to the Statistical Coordinating 
Center at Dana‐Farber. If such an event occurs, three entities (SCIG; site IRB; SC-PAP and 
the DF/HCC DSMB) will convene to determine if it is safe for the subject to remain on 
study, if the study is safe to continue, if all subjects need to be notified, and if any changes 
to the protocol are warranted.
DSMB meetings close with an executive session to summarize and evaluate the overall 
meeting, finalize recommendations, and plan the next meeting. The Principal Investigator 
(Dr. Abel) and the Study Biostatistician (Dr. Kim) will be available as needed for each 
meeting of the DSMB and be responsible for disseminating and implementing any concerns 
to PCORI, the SCIG, the SC-PAP, and other Stakeholders.
The Participating Sites and the Lead Institution will maintain communication regarding a 
patient’s care via email, telephone, pager, and a HIPAA-compliant web app, ACT.md. 
ACT.md will be used as a communication platform for patients, local oncologists, and 
transplant oncologists during Shared Care
Monitoring Reports
The DF/HCC Sponsor will review all monitoring reports to ensure protocol compliance. 
The DF/HCC Sponsor may increase the monitoring activities at Participating Institutions 
that are unable to comply with the protocol, DF/HCC Sponsor requirements or federal and 
local regulations. 
Accrual Monitoring
All accrual will take place at the Lead Institution, DFCI. We anticipate a total of 324 
randomized patients, as well as 84 non-randomized patients who will receive all their care 
at the Lead Institution. Though, no accrual will take place at any Participating Site, we 
anticipate the following number of patients per year to be referred from or live near each 
Participating Site:
 Lifespan Cancer Institute: 21 participants
Dartmouth-Hitchcock: 20 participants
New York Oncology and Hematology: 20 participants

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New England Cancer Specialists: 14 participants
Eastern Maine Medical Center: 14 participants
DFCI Community Cancer Care: 20 participants 
 
AUDITING: QUALITY ASSURANCE
Auditing is a method of Quality Assurance and involves the systematic and independent 
examination of all trial related activities and documents.  Audits determine if evaluated 
activities were appropriately conducted and whether data was generated, recorded and 
analyzed, and accurately reported per the protocol, applicable Standard Operating 
Procedures (SOPs), and the Code of Federal Regulations (CFR).
DF/HCC Internal Audits
 
 All Participating Institutions are subject to audit by the DF/HCC Office of Data Quality 
(ODQ). Typically, approximately 3-4 participants would be audited at the site over a 2 day 
period. If violations which impact participant safety or the integrity of the study are found, 
more participant records may be audited. 
Audit Notifications
It is the Participating Institution’s responsibility to notify the Coordinating Center of all 
scheduled audit dates (internal or NCI) and re-audit dates (if applicable), which involve this 
protocol. All institutions will forward a copy of final audit and/or re-audit reports and 
corrective action plans (if applicable) to the Coordinating Center, within 12 weeks after the 
audit date. 
Audit Reports 
The DF/HCC Sponsor will review all final audit reports and corrective action plans, if 
applicable. The Coordinating Center, must forward any reports to the DF/HCC ODQ per 
DF/HCC policy for review by the DF/HCC Audit Committee. For unacceptable audits, the 
DF/HCC Audit Committee would forward the final audit report and corrective action plan 
to the DFCI IRB as applicable.
Participating Institution Performance
The DF/HCC Sponsor and DFCI IRB is charged with considering the totality of an 
institution’s performance in considering institutional participation in the protocol.
Participating Institutions that fail to meet the performance goals of accrual, submission of 
timely and accurate data, adherence to protocol requirements, and compliance with state 
and federal regulations, may be recommended for a six-month probation period. Such 
institutions must respond with a corrective action plan and must demonstrate during the 
probation period that deficiencies have been corrected, as evidenced by the improved 

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performance measures. Participating Institutions that fail to demonstrate significant 
improvement will be considered by the DF/HCC Sponsor for revocation of participation. A 
DF/HCC Sponsor and/or the DFCI IRB may terminate a site’s participation if it is 
determined that a site is not fulfilling its responsibilities as described above.

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K. Shared Care Patient Schedule (Example)
Week 1-5 (Day 30 – 58): Patient will alternate between the local oncologist and DFCI for weekly 
visits.

Week 1 (day 30): local

Week 2 (day 37): DFCI

Week 3 (day 44): local

Week 4 (day 51): DFCI

Week 5 (day 58): local
Week 6-11 (Day 59 – 100): Patient will alternate between the local oncologist and DFCI for bi-
weekly visits.

Week 6 (day 65): no visit

Week 7 (day 72): DFCI

Week 8 (day 79): no visit

Week 9 (day 86): local

Week 10 (day 93): no visit

Week 11 (day 100): DFCI
Week 12-23 (Day 107-184): Patient will alternate between the local oncologist and DFCI for bi-
weekly visits.

Week 12 (day 107) no visit

Week 13 (day 114): local

Week 14 (day 121): no visit

Week 15 (day 128): DFCI

Week 16 (day 135): no visit

Week 17 (day 142): local

Week 18 (day 149): no visit

Week 19 (day 156): DFCI

Week 20 (day 163): no visit

Week 21 (day 170): local

Week 22 (day 177): no visit

Week 23 (day 184): DFCI