Project SUPPORT (Socio-legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment)
Phase: NA
Conditions: Cancer
Sponsor: Boston Medical Center

 
 
 
 
 
 
 
 
 
 
Project SUPPORT:  
(Socio-legal Services for Underserved Populations Thru Patient 
Navigation to Optimize Resources During Treatment) 
 
Protocol: 9/1/2017 
Clinicaltrials.gov identifying number: NCT02232074 
IRB: H-32599 

                                  
 
1 
 
Contents 
Administrative Information .......................................................................................................... 3 
1. Title......................................................................................................................................... 3 
2. Trial Registration .................................................................................................................. 3 
3. Protocol ................................................................................................................................. 3 
4. Funding IRB .......................................................................................................................... 3 
5. Roles and responsibilities ................................................................................................... 4 
Introduction .................................................................................................................................... 7 
6. Background and Rationale ................................................................................................. 7 
7. Objectives ........................................................................................................................... 10 
8. Trial Design ......................................................................................................................... 10 
Methods ....................................................................................................................................... 11 
9. Study Setting ...................................................................................................................... 11 
10. Eligibility ............................................................................................................................ 11 
11. Intervention ....................................................................................................................... 12 
11.1 Participant Withdrawal .............................................................................................. 14 
12. Outcomes .......................................................................................................................... 15 
12.1 Primary Outcomes..................................................................................................... 15 
12.2 Secondary Outcomes ............................................................................................... 15 
13. Participant timeline .......................................................................................................... 17 
14. Sample Size ..................................................................................................................... 18 
15. Recruitment ...................................................................................................................... 18 
Assignment of interventions ..................................................................................................... 18 
16. Allocation........................................................................................................................... 18 
17. Blinding .............................................................................................................................. 19 
Data collection, management, and analysis .......................................................................... 20 
18. Data Collection ................................................................................................................. 20 
19. Data Management ........................................................................................................... 20 
20. Statistical methods .......................................................................................................... 21 
Monitoring .................................................................................................................................... 22 
21. Interim Analyses .............................................................................................................. 22 
22. Harms ................................................................................................................................ 22 
23. Auditing ............................................................................................................................. 22 

                                  
 
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Ethics and Dissemination .......................................................................................................... 22 
24. Research Ethics Approval .............................................................................................. 22 
25. Protocol Amendments..................................................................................................... 23 
26. Consent ............................................................................................................................. 23 
27. Confidentiality ................................................................................................................... 23 
28. Declaration of Interests ................................................................................................... 23 
29. Access to Data ................................................................................................................. 23 
30. Ancillary and Post Trial Care ......................................................................................... 24 
31. Dissemination Policy ....................................................................................................... 24 
References .................................................................................................................................. 25 
Appendices .................................................................................................................................. 28 
32. Consent Form and Other Participant Documentation ................................................ 28 
32.1 Recruitment Materials ............................................................................................... 28 
32.2 Consent Form ............................................................................................................ 30 
 
 
 

                                  
 
3 
 
Administrative Information 
 
1. Title  
 
Project SUPPORT (Socio-legal Services for Underserved Populations Through 
Patient Navigation to Optimize Resources During Treatment) 
 
2. Trial Registration  
 
Clinicaltrials.gov identifying number: NCT02232074 
 
 
3. Protocol  
 
Version 5: 9/1/2017 
 
4. Funding IRB 
 
This study has been approved by the Boston University Medical Center Institutional 
Review Board. IRB #: H-32599 
 
Funding for Project SUPPORT is provided by: Patient Center Outcomes Research 
Institute (www.PCORI.org  AD-1304-6272) and the American Cancer Society 
(www.cancer.org ACS 124014-RSG-13-368-01-CPPB )  
 
 

                                  
 
4 
 
5. Roles and responsibilities 
Name 
Organization 
Role 
Responsibility 
Tracy Battaglia MD, MPH 
BMC 
PI 
Provide complete oversight of the 
program including its design, 
implementation, analysis and 
dissemination activities. 
Naomi Ko, MD 
 
BMC 
Co-PI 
Provide leadership in coordinating 
intervention with oncology and lead 
clinical adjudication team. 
Kerrie Nelson, PhD 
BUSPH 
Statistician 
Responsible for providing the 
research team with randomization, 
input on the preparation of analyses 
for dissemination and preparation of 
scientific manuscripts. 
Na Wang,  
BUSPH 
Statistical Analyst 
Create data dictionaries, clean 
datasets, develop statistical 
programs and work with statistician 
to conduct analyses. 
Sharon Bak, MPH 
 
BMC 
Data Manager 
Responsible for implementing data 
management and chart abstraction 
procedures and quality control of 
data. 
Penny Price Johnson, 
MC 
BMC 
Study Research 
Coordinator 
Provide oversight of day-to-day 
study management and oversight of 
RAs 
Jennifer Pamphile 
BMC 
RA 
Screen, recruit and enroll eligible 
patients. Complete study surveys. 
Samantha Morton, JD 
 
MLPB 
Executive Director 
MLPB 
Oversee all aspects of integration of 
MLPB support and capacity-building 
in the Intervention Navigator and 
responsible for data collection 
relating to legal needs.  
JoHanna Flacks, JD 
 
MLPB 
Legal Director 
MLPB 
Manage all aspects of legal service 
delivery to participants during the 
intervention period. 
Katie Finn 
BMC 
Patient Navigator 
Supervisor ,  
Hematology/Onco
logy 
Provide clinical supervision in 
oncology for both the intervention 
and the control navigators. 
Laura Ochoa 
BMC 
Intervention PN 
Navigate all patients enrolled in the 
intervention arm for the duration of 
the intervention period. 
Sabrina Morton 
BMC 
Intervention PN 
Amy Proctor  
BMC 
Control PN 
Navigate all patients enrolled in the 
control arm for the duration of the 
intervention period. 

                                  
 
5 
 
Name 
Organization 
Role 
Responsibility 
Deb Bowen, PhD 
BUSPH 
Scientific Steering 
Committee 
Advisor 
Guide the methodology, data 
collection, analyses and 
dissemination activities 
Victoria  Parker, DBA 
BUSPH 
Scientific Steering 
Committee 
Advisor 
Roy Davis 
Community 
Patient Advisory 
Group  
Provide patient perspectives and 
guidance on the conduct of research 
project 
Elizabeth Rhodes 
Community 
Patient Advisory 
Group 
Marilyn Simmons 
Community 
Patient Advisory 
Group 
Carolyn Barnes 
Community 
Patient Advisory 
Group 
Joyce Gandy 
Community 
Patient Advisory 
Group 
 
PI: Principal Investigator, RA: Research Assistant, MLPB: formerly known as Medical 
Legal Partnership | Boston PN: Patient Navigator, BMC: Boston Medical Center, 
BUSPH: Boston University School of Public Health 
 
 
Scientific Steering Committee: 
a. Comprised of the study key personnel and 2 additional investigators at 
Boston Medical Center with expertise in cancer and community health 
interventions: 
 
b. This committee consults with the research team guide the methodology, data 
collection, analyses, and dissemination activities throughout the course of the 
study. 
 
c. Scientific Steering Committee meetings are held a minimum of four (quarterly) 
and a maximum of six (bimonthly) times per year. 
 
 
Patient Advisory Group: 
This committee serves as a formal communication vehicle for patients to take an active 
role in decisions related to the research design, study implementation, and 
dissemination activities. 
 
a. Each member of the Patient Advisory Group brings an individual experience 
of cancer treatment, survivorship, and talents. As the project evolves, division 
into separate working groups such as dissemination and outreach will provide 
an opportunity for these talents to be best represented. 
 

                                  
 
6 
 
b. Each advisory group meeting will include a discussion of current and future 
dissemination activities that will be designed by the patients but supported 
and executed by program staff.  
 
 
c. Patient Advisory Group meetings are held a minimum of four (quarterly) and a 
maximum of six (bimonthly) times per year. The Patient Advisory Group is 
also invited to participate in the quarterly (4 times per year) Community 
Advisory Board meetings. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

                                  
 
7 
 
Introduction 
 
6. Background and Rationale 
 
Cancer inflicts a substantial toll on society with a disproportionate burden borne by minority and 
low income populations. Prevalence of cancer in the US was estimated at 15,112,198 cases in 2015 
with 1,735,350 new cases in 2018 (1, 2). Cancer remains the second leading cause of death in the US, 
accounting for over 598,030 deaths in 2016 (3) Since the year 2000, cancer mortality surpassed heart 
disease as the leading cause of death in women aged 40–79 and men aged 60–79 (4). Breast, lung and 
bronchus, and  prostate cancer account for the highest mortality rates nationwide (1, 5).  It has long been 
recognized that the burden of cancer falls disproportionately on people of color (6). Both incidence and 
mortality are elevated among minorities, especially Blacks, who are more likely to be diagnosed with 
certain cancers, to be diagnosed at advanced stage, and to die from the disease (7). Evidence is clear, 
though, that race and ethnicity are closely related to socioeconomic status (SES), so many racial/ethnic 
disparities are associated with differences in income, education and health insurance coverage (8). 
Studies consistently show that the cancer burden increases as income, insurance status and educational 
attainment decline,(1, 9-11) regardless of race/ethnicity.  
 
Cancer health disparities are growing despite ongoing advances in scientific discovery. While 
overall cancer mortality rates continue to decline, not all segments of the US population benefit equally 
from this progress (12). Death rates in those with lower SES, as defined by education, occupation, or 
residence, have shown little or no decrease, and even increased in some instances (7, 13, 14). Any 
decrease in cancer death rates among minorities has occurred later and has been slower compared to 
Whites. As a result, the gap in mortality rates between advantaged and disadvantaged segments of the 
US population has continued to widen (7, 13, 14). For instance, cancer death rates for men in 1993 were 
two times higher in the least educated compared to the most educated groups, but by 2007 this mortality 
difference had increased to nearly three-fold (7). Despite continued advancement in early detection and 
targeted treatments for women with breast cancer, Black women continue to die from breast cancer at a 
higher rate than their White counterparts (7). 
 
Social determinants of health create obstacles in obtaining timely, quality care and are one of the 
underlying causes for existing cancer disparities. While the interplay of race, poverty and other 
socioeconomic indicators on cancer outcomes is complex, research has clearly documented the impact 
that barriers to accessing cancer care have on patient outcomes, regardless of race/ethnicity (13-16). 
One primary cause of cancer disparities among lower SES populations is the presence of financial, 
structural, and personal barriers to health care, including inadequate health insurance, lower literacy, and 
reduced access to recommended preventive care and treatment service (1). These obstacles to cancer 
services create documented delays in care and are increasingly scrutinized as a source of poor survival 
for many vulnerable populations,(17-26) while large population-based studies find that equal high quality 
treatment can significantly reduce disparities in mortality (27). Thus, evidence-based interventions to 
reduce delays in care resulting from social barriers or obstacles are needed to reduce disparities 
in cancer outcomes. 
 
Patient navigation represents a promising remedy to reduce cancer disparities by intervening to 
address barriers to timely care. Navigation is a patient-centered care coordination model that uses lay 
health workers who are integrated into the healthcare team to support disadvantaged patients for a 

                                  
 
8 
 
defined episode of cancer-related care (28-30). The specific goal of navigation is to reduce delays in care 
by identifying and addressing patient barriers to care. Our research team at Boston Medical Center (BMC) 
pioneered the development of a lay patient navigation model supporting low income minority patients that 
demonstrated significant impact on timely care (31-36) and contributed to widespread dissemination of 
navigation as a current standard in cancer care (6, 37). Patient navigators are trained to work closely with 
patients and providers to identify individual patient obstacles to care (38, 39) and then link patients to 
existing loco-regional resources to overcome them. Barriers documented most frequently include: 
communication issues, scheduling issues and socio-cultural issues such as fear or mistrust. Patient 
navigators helped reduce missed appointments by 50% and also decreased time to screening and 
diagnosis (31, 33, 34).  
 
To facilitate discussion on how to improve navigation services for patients with cancer, the National 
Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine held a workshop 
on Establishing Effective Patient Navigation Programs in Oncology in Washington, DC, on November 13 
and 14, 2017. At this workshop, a broad range of experts, including clinicians, navigators, researchers, 
and patients, provided an overview of patient navigation, explored current models of patient navigation 
programs, identified lessons learned from implementation of patient navigation programs as well as gaps 
in the evidence base, including the need for comparative effectiveness studies to inform best practices 
(40). 
 
In the years leading up to our study design process and proposal submission, preliminary studies 
by our research team suggested that the presence of barriers, particularly certain socio-legal barriers, 
contribute to persistent delays in care despite navigation. We defined socio-legal barriers as social 
problems related to meeting life’s most basic needs that are addressed by existing public policy, law, 
regulation and programming and are thus potentially remedied through legal advocacy/action (41). (Over 
time, socio-legal barriers may become understood as part of (or even subsumed) by the broader category 
of Social Determinants of Health (SDOH), a concept whose taxonomy is still young in the domain of 
academic medicine.  
 
Indeed, while Project SUPPORT was conceptualized in 2011-13, it was not until May 2017 that CMS 
published for the first time on the topic of “health-related social needs”: https://nam.edu/wp-
content/uploads/2017/05/Standardized-Screening-for-Health-Related-Social-Needs-in-Clinical-
Settings.pdf.) Project SUPPORT was grounded in MLPB’s experience that social needs have a legal 
dimension (a) to the extent that a patient has sought resources or assistance from an agency/authority 
(perhaps with the encouragement and help of a patient navigator) and has been denied that support, 
possibly in violation of the patient’s legal rights, or (b) the patient and navigator are aware of the unmet 
social need but not aware that they have legal rights, or if they are aware -- how to exercise them 
effectively.   
 
Unmet essential needs that often involve socio-legal barriers are reflected in the acronym I-HELP initially 
published in Pediatrics in October 2007: Income supports & Insurance; Housing & Utilities; Employment & 
Education; Legal Status; Personal & Family Stability/Safety (42). Each category reflects basic life needs 
that, if not met, may affect health and may be amenable to direct legal advocacy or service intervention 
should initial efforts by patients/families to satisfy these needs be unsuccessful.  
Data from the National Patient Navigation Research Program (PNRP), the largest multi-site study of 
navigation in cancer care to date, documents the impact socio-legal barriers have on equitable cancer 

                                  
 
9 
 
care. Using a list of 20 discrete barriers to care (43), PNRP navigators were also trained to document 
reported patient barriers to care during each patient encounter.  
 
Analyses found that navigated patients with documented barriers to care experience less timely resolution 
of their screening abnormalities; the more barriers present, the less timely their care (44). In a secondary 
analysis, we categorized barriers into two groups: 1) socio-legal barriers and 2) other barriers. Among 
1,493 patients receiving navigation, only 6% had socio-legal barriers to care documented by the 
navigator. The top 3 barriers documented by navigators were: language issues (25%), scheduling issues 
(14%), and fear (12%). Yet, those with socio-legal barriers to care were less likely to have timely 
resolution of diagnostic care (aHR: 0.51, 95% CI: 0.39, 0.66) compared to those with other barriers, even 
when accounting for the presence of multiple barriers. This is one of the most robust findings in the 
Boston PNRP dataset, and a stronger predictor of delay in treatment than insurance status or race and 
ethnicity (45).  
 
These findings are supported by other navigation studies that report outcomes are limited by housing, 
insurance and financial needs (46-48). Therefore, it makes sense that navigation had only a modest 
effect in our low-income population in prior navigation studies, as navigators were not trained to 
identify or address these complex socio-legal barriers to care with remedies external to the 
healthcare system. 
 
Research demonstrating the impacts of integrating legal support into patient care – exemplified 
by the medical-legal partnership approach -- is only beginning to emerge, but much more needs to 
be known regarding the size of effects (15, 41, 49, 50). Current legal reports document improvements in 
self-reported health, including feeling more empowered after receiving MLPB services (50), having 
reduced stress (49), and improvement in one’s general health (15).  
 
A retrospective study of patients in palliative care found that 297 referrals made to an MLPB program 
from 2004 through 2007 addressed patients’ legal needs, from reinstating food stamp benefits, to 
executing last wills and testaments (51). A pilot study of an MLPB tailored for pediatric patients found the 
proportion of families who accessed food and income supports significantly increased, while the 
proportion of families who avoided medical care due to perceived cost and insurance barriers significantly 
decreased (15).  In a pilot study of 20 cancer patients who received legal services, 75% said the legal 
services reduced stress and 45% reported a positive impact on their financial situation, 30% said the 
services helped them maintain their treatment regimen, and 25% said legal services helped them keep 
medical appointments (52). However, rigorous research demonstrating the impact of legal support 
for disadvantaged populations on timeliness of care in general, and of cancer care in particular, 
are lacking, representing a critical gap in the science of cancer disparities.  
 
Project SUPPORT (Socio-legal services for Underserved Populations through Patient Navigation to 
Optimize Resources during Treatment) is an innovative, patient-centered intervention that was designed 
in partnership with a diverse group of community stakeholders to address persistent cancer care 
disparities for vulnerable cancer patients seeking services at an inner-city safety net hospital. We utilize 
Community-Engaged Research methods to design, implement and evaluate a comparative effectiveness 
care delivery randomized controlled trial for a racially/ethnically diverse, low income population with newly 
diagnosed cancer.  
 

                                  
 
10 
 
We hypothesize that compared to standard navigation, a navigation intervention supported by legal 
advocacy will address patient-reported socio-legal barriers and lead to delivery of equitable cancer care. 
Our specific aims are to measure the impact of a legal support-enhanced patient navigation 
intervention on: 
 
1) Clinically relevant outcomes: receipt of timely and quality cancer care. 
2) Patient-reported outcomes: distress, needs and satisfaction. 
3) Intermediate outcomes: socio-legal barriers to cancer care. 
 
7. Objectives  
Research Question: Compared to standard patient navigation, will a more patient-centered navigation 
intervention in partnership with the MLPB ( formerly known as Medical Legal Partnership | Boston) that 
identifies and addresses socio-legal barriers to care in newly diagnosed cancer patients seeking care in 
an urban safety-net result in: 1) improvements in patient-reported distress, perceived needs, self-efficacy 
and satisfaction with the navigator, 2) more timely and better quality care, and 3) elimination of patient-
reported socio-legal barriers to care? 
 
Hypothesis: compared to standard navigation a navigation intervention supported by legal advocacy will 
address patient-reported socio-legal barriers and lead to delivery of equitable cancer care 
 
8. Trial Design 
 
Randomized controlled trial 
 
 
N= 374 newly diagnosed breast & lung cancer patients 
 
187= Control (standard navigation) 
 
187= Intervention (MLPB enhanced navigation) 
 

                                  
 
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Methods 
 
9. Study Setting 
 
Boston Medical Center 
 
Study participants will be identified by screening recently diagnosed breast and lung cancer patients 
presenting for care Boston Medical Center. Eligible patients will be identified using 3 sources (pathology 
reports, referrals and weekly multidisciplinary tumor board conference 
 
10. Eligibility 
 
All patients must meet the following criteria in order to participate in project SUPPORT: 
 
Eligibility criteria:  
 Newly diagnosed lung or female breast cancer  
 18 years or older 
 Receiving cancer treatment at Boston Medical Center  
 English, Spanish or Haitian Creole speaking 
 Patient is eligible within one month (30 days or less) of being notified of her/his cancer diagnosis. 
 
Exclusion criteria include: 
 Patient informed of cancer diagnosis >30 days  
 Patient under 18 yrs. of age 
 Primary language something other than English, Spanish or Haitian Creole 
 Undergoing treatment for concurrent cancer 
 Male breast cancer patients 
 Patient has history of cancer or has received cancer treatment within the last 5 years 
 Institutionalized/cognitive impairment such as: dementia or metabolic, medication or drug induced, 
psychosis (given the unique challenges to their treatment decision making/adherence and the fact 
that the intervention would not include the patient directly, but rather the family). 
 Small Cell Lung Cancer type 
 
 

                                  
 
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11. Intervention 
 
Control arm: Standard Patient Navigation 
a. Current standard of care for cancer patients at BMC 
b. Patient Navigators (PN) complete navigation training through the Oncology Department 
c. PN follows the Care Management Model 
i. 
Case identification 
ii. 
Barrier identification 
iii. 
Care plans to address identified barriers 
iv. 
Long term tracking 
 
 
Intervention arm: MLPB-enhanced patient navigation 
a. Intervention Patient Navigator (IPN) has had standard of care patient navigation training 
through the Oncology Department  
b. IPN interactions with patients are documented by the IPN in the Oncology Navigator 
template in the EMR 
c. Navigator has also completed MLPB orientation and training 
i. Focusing on 3 areas: 
1. Housing 
2. Employment  
3. Disability 
ii. Additional trainings will cover study specific protocol and procedures: 
1. protocol implementation & documentation 
2. administering detailed legal screen/facilitation questions  
3. present information/consult to MLPB 
iii. MLPB training curriculum includes: social determinants of health, range of available 
legal remedies, needs assessment through comprehensive screening, developing 
and implementing care plan through legal triage consultation  
iv. The Intervention PN (IPN) will administer a Detailed Legal Screen to all study 
participants randomized to the intervention group within the first week of study 
enrollment and again at 3 months post-enrollment 
v. Once an initial Detailed Legal Screen is completed with the participant, IPN will 
contact MLPB to discuss the participant’s responses to the screen 
vi. MLPB documents decisions on Level of Legal Need form. 
 
 
 
 
 

                                  
 
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Level of Legal Need Coding 
 
Outcome 
Level of 
need 
Action 
Non-legal 
issue 
0 
Facts conveyed by patient to PN, and PN to MLPB, do not 
reflect that patient has a legal risk/need (as opposed to 
some other type of need). 
Basic legal 
issue 
1 
Facts conveyed by patient to PN, and PN to MLPB, reflect 
that patient has a legal risk/need, but one that can be 
addressed through MLPB sharing referral 
recommendations and/or simple information via a single 
interaction between MLPB and PN (for transmittal to the 
patient by PN, as appropriate). No follow-up consultation 
between MLPB and PN is expected or planned. 
Intermediate 
legal issue 
 
2 
Facts conveyed by patient to PN, and PN to MLPB, reflect 
that patient has a legal risk/need, addressing of which will 
involve multiple consultations between PN and MLPB re: 
available strategies - contemplates an ongoing advocacy 
coaching interaction. 
Complex 
legal issue 
 3 
Facts conveyed by patient to PN, and PN to MLPB, reflect 
that patient has a more complex legal risk/need, so, 
depending on the nature of the issue and the timing, MLPB 
either will: 
(a) provide pro se advice and counsel to patient; 
(b) refer patient to a specialized resource for free 
legal assistance; or  
(c) schedule patient for an MLPB legal intake 
interview.  
Out of MLPB 
scope issue 
9 
Facts conveyed by patient to PN, and PN to MLPB reflect 
that patient has a legal risk/need that is outside the scope 
of MLPB coverage for this study (such as a criminal law, 
immigration law, or personal and family safety & stability 
law issue); MLPB provides readily available referral 
information only. 
 
 
 
 
 

                                  
 
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11.1 Participant Withdrawal  
 
When a participant expresses interest in withdrawing from Project SUPPORT, the RA should try to 
ascertain and document the reasons why the participant has chosen to withdraw and what study 
components, if any, the participant is willing to continue participating in. 
 
Information needed to document withdrawal in REDCap project 
Whether withdrawal was a result of decision made by participant or investigator 
1) Reason(s) for withdrawal, if known 
2) Whether withdrawal was from all components of research study or just the primary interventional component 
3) Date of withdrawal 
4) Did confirmation of withdrawal occur over the phone or in person 
 
 
 
 

                                  
 
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12. Outcomes 
12.1 Primary Outcomes 
Time to first treatment  
1) Timely initiation of care: The receipt of timely care will be defined as initiation of care within 90 
days, as this the shortest delay that has been shown to consistently affect mortality and 
categorized as a dichotomous variable (yes/no). The time element will be calculated from date of 
diagnosis (Time 0) to date of treatment initiation (Time 1). The date chosen for the Time 1 variable 
will depend on the recommend care plan for each patient, as derived from the chart abstraction 
and based on patient presentation, including but not limited to stage at diagnosis and co-morbid 
medical conditions. In all cases Time 1 will be defined as the date of the first treatment after 
patient has received a definitive cancer diagnosis. 
2) Time to initiation of care: continuous outcome defined as the number days from diagnosis (Time 
0) to treatment initiation (Time 1). 
3) Rate of missed appointments: percent of scheduled appointments that are missed over 12 
month period. 
4) Quality of care: Dichotomous variable (Y/N) based on select measures of quality care, as 
developed jointly by the Commission on Cancer, NCCN and American Society of Clinical Oncology 
a. Measured using data abstracted from medical chart 
 
 
12.2 Secondary Outcomes 
Patient-Centered Outcomes (PCOs) 
 
1) Distress: Oncology regulatory bodies recommend routine use of screening for distress, often 
referred to as the sixth vital sign in cancer care, as an integral part of comprehensive care (53). 
Distress is defined as “a multifactorial unpleasant emotional experience of a psychological, social 
and/or spiritual nature that may interfere with the ability to cope with cancer, its physical symptoms 
and treatment”(53). Elevated levels of distress are linked to reduced quality of life, poor adherence 
to treatment and even reduced survival (54-58). We selected the Distress Thermometer (DT)(59) 
as a simple and validated measure of global distress which is widely used in cancer studies. This 
one item instrument utilizes a figure and asks individuals to rate distress levels during the past 
week. Scores range on an 11-point scale from 0 (none) to 10 (extreme distress).  
 
2) Psychosocial needs assessment: Standardized distress screening tools such as the DT are 
insufficient to pinpoint the specific problems contributing to stress (60). Needs assessment is a 
recommended strategy that focuses on identifying unresolved patient concerns contributing to 
distress (61) and lie at the core of our conceptual model for this proposed intervention. 
Assessment of needs is indicative of the gap between patient experiences and expectations. Our 
hypothesis was that a navigation intervention that detects and addresses socio-legal barriers will 
result in a reduction in perceived needs over time. While many validated needs assessment tools 
exist (62), the Cancer Needs Inventory (CaNDI) (63) was selected for several reasons: a) the 7 
domains capture needs reported most commonly by our patient partners, b) the instrument has a 
5th grade reading level, c) it had rigorous psychometric testing in diverse populations  and d) it 
takes less than 8 minutes to complete (63). Patients rate the extent of their concern in the past two 
weeks with 39 items across the 7 domains (anxiety, depression, emotional, social, healthcare, 
practical and physical) on a scale from 1 (not a problem) to 5 (very severe problem). Items are 

                                  
 
16 
 
summed to create a total distress score (63). Based on feedback from both the Intervention and 
Control Navigator along with the Oncology Social Worker, we modified the CaNDI by deleting one 
question related to suicidality. During the early part of recruitment it was determined that the 
question was disruptive to patient care and thus our provider stakeholders recommended we drop 
the question. As a result the CaNDI instrument only included 38 questions. 
3)  Patient satisfaction reflects a core dimension of healthcare quality and patient-centered care (64-
66). Patient satisfaction indicates the extent to which patients’ healthcare experiences match their 
expectations (67, 68). The construct of patient satisfaction has been linked to health status, quality 
of life, and adherence to recommended treatment (69-71). The Patient Satisfaction with 
Interpersonal Relationship with Navigator (PSN-I), a 9-item navigation-focused measure that 
produces a composite score to assess satisfaction with aspects of care in which navigation and 
has been validated in both English-speaking and Spanish-speaking populations (72). This survey 
instrument was administered at the 6 and 12 month follow ups interview. 
 
4) Case Cancer Self-efficacy; measure of patient’s confidence in understanding and participating, 
maintaining a positive attitude and seeking and obtaining information surrounding their cancer 
care. It is a 12 item survey (scale 1-4) with 3 domains: seeking and obtaining information, 
understanding and participating in care, and maintaining a positive attitude. Add responses to 
create score for each subscale & total scale; higher score=higher self-efficacy 
 

                                  
 
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13. Participant timeline  
 
Data collection forms 
Study forms will be administered by a Research Assistant (RA) at the following study time points: 
Baseline, 3, 6 and 12 months follow-up. RAs will work with the patient to schedule study visits to coincide 
with patient’s clinic visits.  
 
 
Form 
Study Time period 
Baseline 
3 month 
6 months 
12 months 
General 
legal screen  
(I-HELP) 
X 
X 
X 
X 
Cancer Needs Distress 
Inventory (CaNDI) 
X 
 
X 
X 
 4-item Brief health 
literacy Screening Tool 
(BRIEF) 
X 
 
 
 
Distress Thermometer 
(DT) 
X 
X 
X 
X 
Communication and 
Attitudinal Self-Efficacy 
(CASE)- Cancer 
X 
 
X 
X 
Employment Baseline 
Questions 
X 
 
 
 
Berkman-Syme Social 
Support Survey (added 
to protocol January 
2015) 
X 
X 
 
 
MOS  (added to 
protocol January 2015) 
X 
X 
 
 
Detailed Legal Screen* 
X 
X 
 
 
Level of Legal Need* 
X 
X 
 
 
Patient Satisfaction 
with Navigation 
 
 
X 
X 
*Intervention arm only 

                                  
 
18 
 
14. Sample Size 
 
Sample size estimates for the clinically relevant outcomes are based on the primary metric: timely 
initiation of primary treatment, a dichotomous outcome (yes/no) calculated for each subject. Since 
clinical outcomes will be derived from the medical record, we do not anticipate any loss to follow up on 
these outcomes. We anticipate our study will have 80% power of detecting an advantage to navigation 
enhanced by a medical-legal partnership, if the enhanced intervention raises the percent in each group 
receiving timely initiation of care from 76% to 90.5% (testing at the two-tailed .05 level) from patient 
navigation alone to legal navigation.  Comparison of the two study groups on our secondary outcome of 
time to initiation of cancer treatment, or the number of days to the start of treatment, through survival 
analysis, takes advantage of more information and should provide somewhat greater power. For example, 
given the above scenario, (76% vs. 90.5% initiation of care by 90 days) and assuming a constant hazard, 
(i.e., exponential survival), a log rank test gives 86% power of detecting a difference between the two 
study groups.  
 
Second, we will conducted separate analyses for the breast and lung cancer participants.  
 
15. Recruitment 
 
Working with oncology providers, Project SUPPORT research assistants approached individuals meeting 
the eligibility requirements on the day they received their cancer diagnosis or shortly thereafter. Once the 
physician had met and discussed the diagnosis with the patient, a research assistant who spoke the 
patient’s language (English, Spanish, or Haitian Creole) introduced the study using the informed consent 
as a guide. The patient was presented with a brief description of the study, a copy of the informed 
consent and would decide whether they would like to discuss the study further or have the research 
assistant contact them at another time. Research assistants followed up with those patients that were 
eligible and interested in participating until they made a decision about enrollment or exceeded the 30 day 
period from diagnosis to be enrolled. The research team maintained a presence in clinic and engaged 
both the new and existing providers at tumor board conference and through frequent email 
communication. 
Assignment of interventions 
16. Allocation 
1) Comparison of study groups on demographic and clinical characteristics will be done to assess the 
success of randomization. With our stratified blocked randomization scheme, treatment groups will 
be balanced with regard to gender, insurance (public/private) and race (white/non-white) in a manner 
proportionate to those in the study population. 
2) To ensure balanced group assignment on key demographic characteristics, randomization for Breast 
Cancer patient (females only) will be based on race (white/nonwhite) and insurance status 
(private/public) resulting in the following strata: 
a. White, Private insurance  
b. White, Public insurance  
c. Nonwhite, Private insurance  
d. Nonwhite, Public insurance 

                                  
 
19 
 
3) If differences in baseline characteristics are detected on other characteristics, these will be included 
as covariates in later analyses.  
17. Blinding 
 
The study statistician conducted the randomization procedure using the statistical software package R 
version 12.0 [ref].  For each group (a through d above), study participants will be randomized into one of 
the two treatment groups:  patient navigation with legal aid, or standard patient navigation, using a block 
randomization design to ensure that some balance between treatment groups is achieved as the study 
progresses.  Random block sizes of 2 and 4 will be employed in a random order.  Within blocks of size 2, 
one patient will be randomly assigned to receive patient navigation with legal aid (Intervention) while the 
other patient will receive patient navigation only (Control).  In block sizes of 4, two of the four patients will 
randomly be assigned to receive patient navigation with legal aid while the other two patients will receive 
patient navigation only.   
 
The investigator and clinicians assessing the outcomes of the study will remain blinded to each 
participant’s treatment group assignment until the study is completed.   
 
The randomization scheme developed by the Biostatistician will be incorporated into the RedCap data 
management system. When Screening forms are entered into Redcap, those patients that enroll will be 
randomized based on their strata and linked to study Ids in RedCap.   
 
Ref: R Core Team (2012). R: A language and environment for statistical computing. R Foundation for 
Statistical Computing, Vienna, Austria. ISBN 3-900051-07-0, URL http://www.R-project.org/ 
 
Assignment of Study ID- each patient that is eligible and has signed a consent form, will be entered into 
the RedCAP project for the study, confirming eligibility before the system randomizes participant into the 
intervention or control group. The patient will be assigned a unique 4 digit study id. The first digit will 
identify which cancer type the patient has been diagnosed with (1 for Breast, 2 for Lung) and then 
numbers will be assigned in sequential order. 
 Ex: The 5th Breast cancer participant will have Study ID 1005 
 Ex:  The 29th Lung cancer participant will have Study ID 2029 

                                  
 
20 
 
 Data collection, management, and analysis 
 
18. Data Collection  
 
General Instructions for Completing Forms 
 
 Forms completed by the participant: 
o Surveys will be administered by the study RA  
o RA will speak with patient preferably in person but possibly over the phone to administer 
surveys.  
o The RA will verbally ask the patient each question on the surveys, to ensure consistency in 
understanding and account for differences in literacy levels of study participants. 
o Responses will be marked on survey instrument and returned to office for data entry and proper 
storage. 
o Before completing the interview session the RA will review the surveys to ensure there are no 
missing items or data, and if any items were left blank the RA will follow-up with the participant 
before the end of their meeting to collect any missing data 
 
 Forms completed by research personnel: 
o Screening information, clinical abstractions will be completed by trained research personnel 
o Training- study team members will be trained on abstracting relevant data from the Electronic 
Medical Record. Training will cover basic cancer care and treatment as well as how to review 
an electronic medical chart and identify key clinical data elements for data collection 
o Adjudication/quality review- to ensure quality data a clinical adjudication team will review and 
confirm key clinical data elements. Key variables will be abstracted by  a second abstractor, 
results compared and discrepancies flagged for resolution by Data Manager 
 
19. Data Management 
 
Missing data/integrity of data 
Every six months data will be reviewed by the Data Manager, the Biostatistician and the Analyst to 
determine if any patterns for missing data are present. If issues are found, adjustments will be made to 
the training and data collection protocol. 
 
Retention 
To minimize attrition research assistants worked with each patient’s schedule to identify a convenient 
meeting time for the patient to complete his/her surveys. Patients had the option of completing follow ups 
in person or over the phone. The flexibility of the research assistants coupled with their language 
concordance with the patients and incentives provided after each follow-up, contributed to study retention 
and high follow up rates. 
 
REDCap Data management system 

                                  
 
21 
 
REDCap is a password protected, HIPAA compliant, web-based application for building and managing 
online surveys and databases. It also has the ability to track and report on study progress at the 
participant level as well as the study level. Data Collection forms will be entered onsite through REDCap 
by a trained member of the research staff. For quality assurance purposes, 10% will be verified by a 
second staff member. 
 
Data Storage 
All paper data collection tools will return to the WHU office after completion. They will be stored in a 
secure, locked cabinet within the office, only accessible to study staff with ID access and will be retained 
for 7 years after the last participant has completed the project. 
 
 
20. Statistical methods 
 
Population under study: Patients newly diagnosed with breast or lung cancer at BMC who volunteer to 
participate in the study and complete the I-HELP general legal screen at baseline to indicate the presence 
of legal need.   
 
Analysis 
 
Primary Clinical Outcomes: To measure the impact of patient navigation enhanced by MLPB 
intervention on receipt of timely and quality cancer care: 
 
  Our primary analysis will use multiple logistic regression models to compare the proportion of 
patients with timely initiation of treatment across study groups, adjusting for the influence of 
race/ethnicity (white vs non-white), cancer site, insurance status (private vs public), and other 
covariates that may have a significant effect on the outcome and may be unbalanced across the 
two study groups.  
 Study groups will also be compared on the secondary clinical outcome of time to initiation of 
primary cancer treatment (the number of days from diagnosis to start of treatment) through Kaplan-
Meier survival curves (unadjusted analyses) and Cox proportional hazards regression models 
controlling for cancer site and other covariates (adjusted analysis). 
 Receipt of quality care for each cancer type will be analyzed through logistic regression.  
 For the analysis of the rate of missed appointments, patients will differ on the number of scheduled 
appointments over the study period. We will generate summary measures of the rate and total 
numbers of missed appointment for the total study cohort and by treatment group.  
 The primary analysis will include only participants who have legal issues at baseline (defined by 
the results of their baseline I-HELP general legal screen, which will take place within one month of 
new diagnosis).   This will be the official sample of patients which the sample size calculations are 
based (n=117 in each group adjusting for 10% dropout). 
 
 

                                  
 
22 
 
Secondary outcomes: To measure the impact of patient navigation enhanced by MLPB 
intervention on patient-reported outcomes: distress, needs, and satisfaction: 
 
 Patient-reported outcomes will be measured at baseline, 3 month follow-up, 6 month follow-up, and 
12 months using summation scores with established subscales.  
 Multiple linear regression models controlling for baseline levels of the outcome (i.e., analysis of 
covariance models) will be used to compare study groups on changes in distress and psychosocial 
needs at follow-up. Multiple linear regression models will also examine intervention effects on 
satisfaction scores.  
 Covariates in each model may include age, race/ethnicity, stage of disease, and other covariates 
that may have a significant effect on the outcome and may be unbalanced across the two study 
groups. 
 
Monitoring 
 
21. Interim Analyses 
Due to the nature of the study interim analyses will not be performed. 
 
22. Harms 
Involvement in this study has minimal risks. The main potential risk of this study is loss of confidentiality. It 
is unlikely that this will occur as several safeguards in place, including, entering data into a HIPAA 
compliant database requiring two-step authentication with passwords, keeping forms in a locked cabinets 
and only conducting data analysis on a data set that is coded and does not contain any direct identifiers. 
There is also a risk that some of the questions may make the participants feel uncomfortable. Participants 
will be reminded that they can refuse to answer questions that they are uncomfortable with. 
 
23. Auditing 
An external audit was not required for this project. However, eligibility for each participant enrolled will be 
verified by the Study Coordinator or the Data Manager. 
 
Ethics and Dissemination 
 
24. Research Ethics Approval 
This protocol, the informed consent forms (Appendix 32.2), and associated study documentation was 
reviewed by the Boston Medical Center IRB and Research Ethics Committee for scientific content and 
compliance with all applicable research and human participants regulations and subsequently approved 
on 12/04/2013. 
 

                                  
 
23 
 
25. Protocol Amendments 
Any modifications to the protocol which is determined to impact the study will be subject to review and 
approval by BMC IRB. This may include but is not limited to changes of objectives, design, patient 
population, sample sizes, or procedures. Administrative changes to the protocol that are determined to 
have no effect on study conduct will be documented by the internal study team throughout the course of 
the study. 
26. Consent 
 
Prior to consent the all interested subjects will be informed that they may be asked sensitive questions, 
including questions about the medical status of the patient and their family members, income and means 
of support, health insurance and current housing situation, immigration status or domestic violence. The 
patients assigned to the navigation arm will be asked more sensitive questions than the standard 
navigation arm due to the questions contained in the legal intake. They will be informed that they do not 
have to answer any questions that make them feel uncomfortable, and that not participating or not 
answering any questions will not impact the medical care they receive. If the patient is unable to stay after 
their oncology appointment to enroll in the study but they are interested in participating, informed consent 
will be conducted and the patient will be given the option of coming to BMC at another time to meet with 
the PN in a private setting or complete the baseline and follow –up surveys over the phone. To review the 
informed consent procedure and associated form refer to Appendix 32.2 and 32.3 respectively. 
 
27. Confidentiality 
 
We have many safeguards in place, including keeping files in a locked cabinets and only conducting data 
analysis on a coded data set that does not contain any identifiers. Only IRB approved study staff will have 
access to the study data. All paper related materials for this study that contains identifiers will be stored in 
a locked cabinet in the PIs office and only the PI and RA will have access to it. All data will be kept on a 
password protected computer and only the study PI and study RA will be able to access it. The password 
to access the data will be changed every 60 days. It is also possible that the participants may feel 
uncomfortable about some of the questions being asked as they might be perceived as sensitive in 
nature. The participants will be informed that they don't have to answer any questions that make them feel 
uncomfortable and can stop the interview at any time. 
 
28. Declaration of Interests 
BMC Investigators, MLPB and research team members complete an annual Conflict of Interest form 
required by the Compliance department at BMC and TSNE. 
 
29. Access to Data 
All data will be stored at BUMC and analyzed by BUMC staff. Research staff may look at aggregate data 
during research meetings. All participants will be assigned a subject ID code during the informed consent 
process and will only be known by this assigned ID code during discussions with MLPB and during data 
analysis. The master code for subject IDs will only be seen by the patient navigator who will be doing the 
initial consenting of the participants and assigning the code, the research assistant and study PI listed on 
the study application. All data will be kept in a locked office and on a locked computer. The Principal 
Investigator will be given access to the cleaned data sets.  

                                  
 
24 
 
 
30. Ancillary and Post Trial Care 
 
Due the low risk nature of the study, ancillary provisions were not required. 
 
31. Dissemination Policy 
 
The Project SUPPORT research team, Scientific Advisory Board and the Patient Advisory Group will work 
together to consider options for dissemination and the best way to convey the results of complex 
statistical analyses. The research team has generated a list of potential analyses and papers, beyond the 
primary outcome and who will act as a lead author for each of these potential papers. 
 
 

                                  
 
25 
 
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Appendices 
32. Consent Form and Other Participant Documentation 
 
32.1 Recruitment Materials 
 
 
Research Study Opportunity 
Project SUPPORT (Socio-legal Services for Underserved Populations thru Patient Navigation to 
Optimize Resources during Treatment) 
We are doing a study on medical-legal issues that could impact cancer care and treatment.  This 
study is trying to test what type of patient navigator training works the best for cancer patients at BMC.  
Participants will be randomly placed in one of two groups; one group will be assigned a standard patient 
navigator, one group will get a patient navigator who has special training in legal needs common to 
cancer patients.  
 
Who can join the study? 
 Newly diagnosed breast or lung cancer patients who get cancer care at Boston Medical Center 
 Over 18 years of age 
 Speak English, Spanish or Haitian Creole. 
 
What will I have to do? 
You will complete surveys within one month of your diagnosis, 3 months, 6 months and 1 year later. We 
will also get some medical information about your treatment from your medical record.  
You will receive a $25 CVS gift card every time you take the surveys. You can make $100 in CVS gift 
cards for your involvement in this study.  

                                  
 
29 
 
Participating in this study will not affect your care. All information given will not be shared with anyone 
outside of the research team.   
If you are interested in participating in PROJECT SUPPORT please contact the research 
assistants: at 617-XXX-XXXX 
 
 
 

                                  
 
30 
 
32.2 Consent Form   
 
RESEARCH CONSENT FORM 
Title of Project: Project SUPPORT (Socio-legal services for Underserved Populations thru Patient 
Navigation to Optimize Resources during Treatment) 
 
IRB Number: H-32599 
Sponsor: Patient Centered Outcomes Research Institute, (PCORI) and the Medical Legal Partnership, (MLP) 
Intervention. 
 
Principal Investigator: 
Tracy Ann Battaglia, MD, MPH 
Tracy.Battaglia@bmc.org 
Center of Excellence in Women’s Health 
801 Massachusetts Avenue 
Boston, MA 02118 
617-638-8036 
 
Background 
This research study is being conducted by a research team from Boston Medical Center (BMC) and the 
Medical Legal Partnership| Boston (MLP|Boston). MLP/ Boston is not part of BMC but is a private non profit that 
BMC is partnering with for this study. You have been invited to participate because you have recently been 
diagnosed with Breast or Lung Cancer. 
 
Purpose 
The purpose of this study is to see if assessing legal needs of newly diagnosed breast or lung cancer patients 
leads to better clinical outcomes. 
 
What Happens In This Research Study 
 
You will be one of approximately 374 subjects to be asked to participate in this study. 
The research will take place at the Boston University Medical Center. 
Once you have agreed to participate in the study, you will be asked to complete 8 different surveys. These 
surveys will ask you questions about your level of distress, housing issues, disability issues, employment 
issues and personal stability. These questions will help us learn more about you and any problems you might 
be having. 
After you finish those surveys you will be put into one of two groups. One group will receive assistance from a 
patient navigator (PN). This Patient Navigator will remind you of your upcoming appointments and help you 
with any issues that may make it difficult for you to come to an appointment. The other group will have a 
Patient Navigator that also has special training to help patients who have legal needs. If that Patient Navigator 
decides you are in need of legal services she will get you access to a lawyer from MLP/Boston free of charge. 
You will not have a choice which group you are placed in for the study. The assignment to one group or the 
other is done by random placement, like the flip of a coin. 
You will be asked to complete several surveys 3, 6 and 12 months later so we can see how your needs have 

                                  
 
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changed over time. In addition to the 3, 6 and 12 month surveys, we will call you at 9 months to confirm or 
update your contact information. These surveys can be done either in person at one of your doctor 
appointments or over the telephone. It will take around 60-90 minutes to complete the surveys now and when 
you take them again at 3, 6 and 12 months. 
 
If you are enrolled in the group that gets access to a lawyer, and your answers to the questions asked in the 
study indicate that you need to speak with a lawyer, that meeting with the lawyer is estimated to take an 
additional 60-90 minutes. We will also collect information about your medical status from your medical record 
at 6 and 12 months after enrollment. We will look for data on your cancer treatment and overall health. 
 
Risks and Discomforts 
It is possible that you may be uncomfortable answering certain questions. If this happens, you may skip those 
questions. There is a small risk that people who are not the researchers could find out information that is 
collected. However, the study staff has taken steps to minimize this risk and will make sure all study materials 
are stored securely where only study staff can see them. Once the intake interview is completed all data will be 
coded in a special way and you will only be known by a coded study ID and your name and contact information 
will be kept in a separate location. 
 
There may be unknown risks/discomforts involved. Study staff will update you in a timely way on any new 
information that may affect your health, welfare, or decision to stay in this study. 
 
Potential Benefits 
There is no direct benefit for participation. If you are in the intervention part of the study, this study may help 
identify an unmet legal need(s) and the potential to meet with a legal representative from the MLP/Boston to 
help you. 
 
Alternatives 
You can contact your local legal aid services or a private lawyer for help with any legal or social service needs 
or concerns you may have. You do not have to be in the study. If you choose not to be in the study you may 
receive the usual patient navigation to assist you with your appointments if your doctor feels that it would be 
helpful for you. 
 
Subject Costs and Payments 
There are no costs for you to participate in this study. You will be compensated with a $25 gift card once you 
have completed each part of the study (Enrollment, 3 6 and 12 month surveys) for a total of $100. 
 
Confidentiality 
Information from this study and from your medical record may be reviewed and photocopied by the state and 
federal regulatory agencies such as the Office of Human Research Protection as applicable, and the 
Institutional Review Board of Boston University Medical Center. Information from this study and from your 
medical record may be used for research purposes and may be published; however, your name will not be 
used in any publications. 
 
Subject's Rights 
By consenting to participate in this study you do not waive any of your legal rights. Giving consent means that 
you have heard or read the information about this study and that you agree to participate. You will be given a 
copy of this form to keep. 
If at any time you withdraw from this study you will not suffer any penalty or lose any benefits to which you are 
entitled. 
You may obtain further information about your rights as a research subject by calling the Office of the 
Institutional Review Board of Boston University Medical Center at 617-638-7207. 

                                  
 
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The investigator or a member of the research team will try to answer all of your questions. If you have 
questions or concerns at any time, or if you need to report an injury while participating in this research, Use the 
phone number on the first page of this form. 
 
Right to Refuse or Withdraw 
Taking part in this study is voluntary. You have the right to refuse to take part in this study. If you decide to be 
in the study and then change your mind, you can withdraw from the research. Your participation is completely 
up to you. Your decision will not affect your being able to get health care at this institution or payment for your 
health care. It will not affect your enrollment in any health plan or benefits you can get. 
If you choose to take part, you have the right to stop at any time. If there are any new findings during the study 
that may affect whether you want to continue to take part, you will be told about them as soon as possible. 
 
The investigator may decide to discontinue your participation without your permission because he/she may 
decide that staying in the study will be bad for you, or the sponsor may stop the study. 
 
Protection of Subject Health Information 
You have certain rights related to your health information. These include the right to know who will get your 
health information and why they will get it. If you choose to be in this research study, we will get information 
about you as explained below. 
- medical information from your medical chart will be collected as part of this study 
 
HEALTH INFORMATION ABOUT YOU THAT MIGHT BE USED OR GIVEN OUT DURING THIS RESEARCH: 
 
Information from your hospital or office health records at BUMC/BMC or elsewhere. This information is 
reasonably related to the conduct and oversight of the research study. If health information is needed from 
your doctors or hospitals outside of BUMC/BMC, you will be asked to give permission for these records to be 
sent to the researcher. 
 
□ New health information from tests, procedures, visits, interviews, or forms filled out as part of this research 
study. 
 
WHY HEALTH INFORMATION ABOUT YOU MIGHT BE USED OR GIVEN OUT TO OTHERS 
The reasons we might use or share your health information are: 
□ To do the research described here 
□ To make sure we do the research according to certain standard set by ethics, law, and quality groups 
 
 
PEOPLE AND GROUPS THAT MAY USE OR GIVE OUT YOUR HEALTH INFORMATION 
 
□ PEOPLE OR GROUPS WITHIN BUMC/BMC 
o 
Researchers involved in this research study 
o 
The BUMC Institutional Review Board that oversees this research 
□ PEOPLE OR GROUPS OUTSIDE BUMC/BMC 
o 
People or groups that we hire to do certain work for us, such as data storage companies, 
or laboratories. 
o 
Federal and state agencies if they are required by law or involved in research oversight. 
Such agencies may include the U.S. Department of Health and Human Services, the 
National Institutes of Health, the Massachusetts Department of Public Health. 
o 
Organizations that make sure hospital standards are met 
o 
The sponsor(s) of the research study, and people or groups it hires to help them do the 
research 

                                  
 
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o 
Other: MLP BOSTON 
Some people or groups who get your health information might not have to follow the same privacy rules that 
we follow. We share your health information only when we must. We ask anyone who gets it from us to protect 
your privacy. However, once the information leaves BUMC, we cannot promise that it will be kept private. 
In most cases any health data that is being given out to others is identified by a unique study number and not 
with your name. So, although in some cases it is possible to link your name to the study data, this is not usually 
done. 
 
TIME PERIOD FOR USING OR GIVING OUT YOUR HEALTH INFORMATION 
Because research is an ongoing process, we cannot give you an exact date when we will either destroy or stop 
using or sharing your health information. 
 
YOUR PRIVACY RIGHTS 
 
□ You have the right not to sign this form that allows us to use and give out your health information for 
research. If you don't sign this form, you can't be in the research. This is because we need to use the 
health information to do the research. 
□ You have the right to withdraw your permission to use or share your health information in this 
research study. If you want to withdraw your permission, you must write a letter to the researchers in 
charge of this research study. 
 
If you withdraw your permission, you will not be able to take back information that has already been used or 
shared with others. This includes information used or shared to do the research study or to be sure the 
research is safe and of high quality. If you withdraw your permission, you cannot continue to be in the study. 
 
□ You have the right to see and get a copy of your health information that is used or shared for 
research. However, you may only get this after the research is finished. To ask for this information, 
please contact the person in charge of this research study. 
 
IF RESEARCH RESULTS ARE PUBLISHED OR USED TO TEACH OTHERS 
 
The results of this research study may be published in a medical book or journal, or used to teach others. 
However, your name or other identifying information will not be used for these purposes without your specific 
permission. ) 
 
Signing this consent form indicates that you have read this consent form (or have had it read to you), 
that your questions have been answered to your satisfaction, and that you voluntarily agree to 
participate in this research study. You will receive a copy of this signed consent form. 
 
 
 
 
Subject (Signature and Printed Name) Date 
 
 
 
Person Obtaining Consent (Signature and Printed Name) Date 
BUMC/BMC 
 
 
 
Witness (Signature and Printed Name) Date (To be used if applicable)