A Mobile Health (mHealth) Case Management System for Reducing Pediatric Cancer Treatment Abandonment
Phase: NA
Conditions: Burkitt Lymphoma, Retinoblastoma, Diffuse Large B-cell Lymphoma
Sponsor: Duke University

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Research Summary 
 
 
1. 
Protocol Title:  
 
A DIGITAL CASE MANAGEMENT SYSTEM FOR REDUCING PEDIATRIC CANCER TREATMENT 
ABANDONMENT IN TANZANIA (NCT03677128) 
 
2.  Purpose of the Study:  
 
Digital case management systems can facilitate compliance with protocol-driven treatment and ultimately 
help to close the discrepancy between low- and middle-income countries (LMICs) and high-income countries 
(HICs) in survival outcomes among pediatric cancer patients. Unfortunately, few studies have implemented 
and evaluated such digital case management systems for pediatric oncology in LMICs, despite higher 
treatment abandonment rates reported in LMICs compared to HICs. In response to the urgent need for 
interventions to reduce treatment abandonment and improve survival rates for pediatric oncology patients in 
LMICs, including Tanzania, our proposal has the following specific aims: 
 
Aim 1: To adapt an open-source digital case management platform to incorporate standardized 
pediatric oncology protocols. 
Aim 2: To evaluate the efficacy of the digital case management application for improving provider 
compliance with standardized pediatric oncology protocols and reducing treatment abandonment. 
 
A secondary objective of the study is to understand factors that facilitate or inhibit the implementation of 
mNavigator in tertiary care facilities for pediatric cancer. 
 
3.  Background & Significance:  
 
Each year, approximately 220,000 children globally are newly diagnosed with cancer. Over 85% of these 
new diagnoses are made in low- and middle-income countries (LMICs) [1]. Survival rates in LMICs are 5-
25% compared to 80% in high-income countries (HICs). One of the primary contributors to the discrepancy 
in survival outcomes between LMICs and HICs is a high rate of treatment abandonment in LMICs, defined 
as refusal to initiate or failure to complete curative treatment. Treatment abandonment rate in Tanzania is 
higher than in other LMICs (40% compared to 10-25%), directly impacting patient survival. In HICs, protocol-
driven treatment for children with cancer has led to increased treatment compliance and large improvements 
in survival. However, it is often not feasible or appropriate to use protocol-driven treatment in LMICs without 
necessary supportive care, human resources and infrastructure. Not surprisingly, protocol-related 
compliance is lower in LMICs compared to HICs [2-9]. Mobile technologies for health (i.e., mHealth) can 
facilitate implementation of and compliance with standardized pediatric oncology protocols through step-by-
step decision support algorithms, reminders and alerts related to patient visits, and timely data for health 
service coordination with allied health providers (e.g., nurses, pharmacists etc.) [10-12]. This 
multidisciplinary team from Duke University and Dimagi Inc. in USA, and Bugando Medical Centre (BMC) in 
Tanzania, proposes to adapt, implement, and evaluate an mHealth case management system, called 
mNavigator, for improving health provider compliance with standardized pediatric oncology protocols. 
 
4.  Design & Procedures:  
 
Study location:  
This study will be conducted at the Bugando Medical Centre (BMC) in Mwanza, Tanzania. 
 
Describe the study, providing detail regarding the study intervention (drug, device, physical 
procedures, manipulation of the subject or the subject’s environment, etc.): 
 
Study intervention 
There are approximately 150 pediatric oncology patients seen annually at BMC. Patients are currently 
registered (via paper file) by either pediatric patient navigator or clinic coordinator. Patients are seen by 
medical providers, and treatment plan is prescribed.  
 
The proposed mHealth case management system, called mNavigator, will be developed by adapting Dimagi 
Inc.’s CommCare platform, an open source software for digital case management. Once mNavigator is 
implemented, routine pediatric oncology patient clinical data, part of standard of care, will be entered in 

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mNavigator. This will include clinical care information, case management, decision support, and behavior 
change communication.  
 
The study intervention will include adding to routine clinical information by incorporating into mNavigator two 
nationally-approved treatment protocols, one for Burkitt lymphoma (BL) and the other for retinoblastoma 
(Rb), to facilitate protocol-driven treatment. Of the 150 BMC pediatric oncology patients entered annually 
into mNavigator, approximately 50 patients are expected to be diagnosed with either Burkitt lymphoma (BL) 
or retinoblastoma (Rb). In this study, mNavigator will be used for additional case management and decision 
support with these BL or Rb patients.  
 
Patient navigators or clinical coordinators will perform activities in mNavigator such as:  
• 
Register pediatric oncology patients. 
• 
Enter pre-diagnostic labs and imaging tests. 
• 
Assign patients to BL, Rb, or non-BL/Rb cohorts for further assessment. 
• 
Complete and review pre-treatment staging and laboratory checklists for patients with preliminary 
Rb or BL diagnosis, to facilitate protocol adherence. 
• 
Deliver cancer educational information, possibly in video format. 
• 
Document parental knowledge of their child’s disease. 
• 
Review treatment guidelines with decision support algorithms to facilitate communication between 
care coordinators and prescribing physicians. 
• 
Enter information on changes in treatment plan, including referrals to outside hospitals, second line 
treatment, or palliation. 
• 
Follow-up with patients to record outcomes (healthy, relapse, lost to follow up, death, etc.). 
 
mNavigator will be implemented at BMC. mNavigator users will be both those who will directly use 
mNavigator and/or those whose work will be impacted by mNavigator. Users will be BMC health 
professionals who provide routine clinical care for pediatric cancer patients including patient navigators, 
clinical coordinators, health providers and other clinical staff as well as non-clinical staff and other key 
stakeholders whose buy-in will be necessary for the successful implementation of mNavigator. 
 
Identify procedures, tests and interventions performed exclusively for research purposes or more 
frequently than standard of care. Include alternative therapies, concurrent therapies discontinued 
per protocol, risk benefit ratio, and use of tissue/specimens.  
 
Study procedures and activities: 
 
Study procedures and activities for Aim 1: 
 
Aim 1: To adapt an open-source digital case management platform to incorporate standardized 
pediatric oncology protocols.  
 
For Aim 1, Duke and Tanzanian PIs and research staff, with support from Dimagi Inc. will develop the first 
iteration of mNavigator for digital management of BL and Rb patient care. This initial mNavigator prototype 
will be presented to users who will be both those directly using mNavigator and/or those whose work will be 
impacted by mNavigator. Users will be BMC health professionals who provide routine clinical care for 
pediatric cancer patients including patient navigators, clinical coordinators, health providers and other 
clinical staff as well as non-clinical staff and other key stakeholders whose buy-in will be necessary for the 
successful implementation of mNavigator. 
 
We will elicit feedback from users to inform revisions, including edits to forms and displays in mNavigator, to 
have a functional system ready for implementation and pilot efficacy evaluation in Aim 2. To capture 
feedback on usability (perceived ease of use) and acceptability of the system we will: 
• 
Conduct observations of users utilizing and testing mNavigator 
• 
Guide users through a think-aloud process for providing feedback while using mNavigator. It will 
include filling out a brief survey and answering open-ended questions about their user experience. 
This will take approximately 45-60 minutes. Sessions may be audio-recorded using an encrypted 
digital device to help with documentation. These may be transcribed and, if conducted in Swahili, 
will be translated into English. 
 
In addition, we will use (n=50) retrospective records to enter into mNavigator to test app content (skip 
patterns, calculations, hidden values etc.) prior to implementation. 

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The development of the mNavigator system and findings from the assessment of system usability and 
acceptability from aim 1 will be presented in peer-reviewed manuscripts. 
 
Study activities and procedures for Aim 2 and the secondary objective: 
Aim 2: To evaluate the efficacy of the digital case management application for improving provider 
compliance with standardized pediatric oncology protocols and reducing treatment abandonment. 
Secondary objective: to understand factors that facilitate or inhibit the implementation of 
mNavigator in tertiary care facilities for pediatric cancer 
 
For Aim 2, Duke and Tanzanian PIs, and research staff will train approximately 15 BMC personnel on 
mNavigator. Those trained will be mNavigator users who will be both those directly using mNavigator and/or 
those whose work will be impacted by mNavigator. Users will be BMC health professionals who provide 
routine clinical care for pediatric cancer patients including patient navigators, clinical coordinators, health 
providers and other clinical staff as well as non-clinical staff and other key stakeholders whose buy-in will be 
necessary for the successful implementation of mNavigator. BMC IT staff will be trained on how to further 
customize, deploy and manage the platform. Training will be followed by supported implementation. 
 
mNavigator will be used as the standard of care for entering clinical data and managing care of pediatric 
cancer patients at BMC. All pediatric cancer patients at BMC will be registered and tracked in mNavigator. 
For research purposes, we will consent anyone who receives a clinical diagnosis of Rb or BL. Data for only 
those providing informed consent will be used in the research study (with the exception of historical data). 
Over the course of about one year, research staff will use mNavigator for treatment management of about 
50 enrolled pediatric patients with pre-clinical diagnosis of BL or Rb (Typical treatment duration: 3 months 
for patient with BL and 4 months for patient with Rb). 
 
To measure compliance with standardized pediatric oncology protocols and reduction in treatment 
abandonment (defined as missing four or more consecutive weeks of treatment or follow-up while still on 
therapy), we will use personal and clinical data points routinely collected as part of clinical visits along with 
the data entered into mNavigator for additional case management as described in the previous section. 
 
Measurement of study outcomes is guided by the RE-AIM framework. In mNavigator, we will collect data 
points that will allow us to measure outcomes in the following domains:  
• 
Reach – e.g., proportion of eligible patients for whom protocol was used. 
• 
Efficacy – e.g., proportion of cases that abandoned care, with treatment completion and time from 
hospital presentation to confirmed diagnosis 
• 
Adoption – e.g., proportion of providers who use the protocol, provider acceptability and satisfaction 
with mNavigator content, ease of delivery and credibility 
• 
Implementation/Compliance? – e.g., proportion of protocol steps completed per patient 
• 
Maintenance (measured in future studies) 
 
We will compare treatment protocol compliance between BL/Rb retrospective patients (treated between 
2015-2018 when standardized treatment protocols for BL and Rb were introduced at BMC, but before 
introduction of mNavigator) and BL/Rb prospective patients (treated using case management provided by 
mNavigator). To collect retrospective medical record data, trained research staff will abstract medical data 
into CommCare from paper records for up to 50 files per year (for a total of approximately 200) of patients 
diagnosed with BL and Rb between 2015-18. Items abstracted will include as many data points available in 
paper records that are included in mNavigator.  
 
We will assess implementation factors that may facilitate or inhibit implementation of the system. This 
information will be used to inform scale-up and design of future studies. 
 
We will periodically conduct observations, surveys and/or checklist with users to collect data related to the 
following areas: 
• 
Technical functionality (such as content, time to complete forms) 
• 
Technical stability (network connectivity, server downtime, failure and errors; issues with quality of 
data and system, device damage) 
• 
Fidelity and quality of system implementation. These data will help us assess and describe the 
fidelity of the intervention (how mNavigator was used in practice and whether protocol steps were 
followed) 
 

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We will invite mNavigator users to complete a 30-45 min in-depth interviews to discuss system acceptance 
and usability, and satisfaction. Using Organizational Readiness for Implementing Change (ORIC), we may 
also revisit the degree of change in readiness and commitment over time to use mNavigator and change in 
efficacy, a belief in the capacity at BMC to implement mNavigator. All above study activities related to use of 
mNavigator will be conducted with mNavigator users who will be both those directly using mNavigator and/or 
those whose work will be impacted by mNavigator. Users will be BMC health professionals who provide 
routine clinical care for pediatric cancer patients including patient navigators, clinical coordinators, health 
providers and other clinical staff as well as non-clinical staff and other key stakeholders whose buy-in will be 
necessary for the successful implementation of mNavigator. 
 
For the secondary objective, to document factors that may facilitate or inhibit implementation of mNavigator, 
we will use a process of Continuous feedback from users as documented above. User feedback will be 
documented in several ways including: mNavigator documentation regarding system errors or failures; in-
depth interview to probe users to reflect on factors that facilitated or challenged their use of mNavigator; and 
through brief surveys regarding acceptability and implementation. 
 
We will also reach out to parents or caregiver of pediatric oncology patients to conduct in-depth interviews to 
explore factors that may contribute to treatment abandonment (barriers to initiating or completing treatment). 
We will complete an interview with as many parents as can be reached, recognizing that follow-up will be 
difficult. The interview may be audio-recorded using an encrypted digital device to help with documentation. 
These will be transcribed and, if conducted in Swahili, will be translated into English. 
 
Activities contributing to increased research capacity at BMC will also be documented. Examples of research 
capacity include: (a) technology transfer and research capacity for implementation of mHealth interventions 
among BMC investigators through collaborations With Dimagi Inc. on aims 1 and 2; (b) continued development 
of research management capacity through weekly conference calls between project coordinators regarding 
budget management, quality assurance oversight, and local staff leadership. Tanzania-based investigators 
are intellectual partners in the study, contributing to proposal writing and all aspects of study design, 
implementation, analyses, and manuscript development, thereby contributing to improved research capacity 
in the region. 
We will document the process of training and ongoing support provided to mNavigator users. Results of 
protocol implementation and barriers to adoption, and of the feasibility and pilot efficacy evaluation of 
mNavigator will be presented in peer-reviewed manuscripts. 
 
Study outcomes are summarized in table below. 
Outcome 
Measurement 
Data Source 
Description 
Efficacy outcomes 
Protocol compliance 
with mNavigator 
Calculated as proportion 
of protocol steps 
completed, based on a 
compliance checklist 
mNavigator data from 
prospectively registered 
pediatric cancer 
patients from July 2019 
– July 2020 
 
Historical protocol 
compliance 
Calculated as proportion 
of protocol steps 
completed, based on a 
compliance checklist 
Data from paper charts 
for patients  registered 
at BMC from 2015 – 
2018 entered into 
mNavigator 
 
Change in protocol 
compliance (primary 
outcome) 
Continuous variable 
calculated as a 
difference in protocol 
compliance with 
mNavigator and 
historical compliance. 
See above 
 
Treatment 
abandonment rate 
Calculated as the 
proportion of patients 
registered in mNavigator 
who abandoned care. 
Treatment 
abandonment is defined 
as missing four or more 
consecutive weeks of 
Data from mNavigator 
(outcome form) 
 

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treatment or follow-up 
while still on therapy. 
Treatment completion 
rate  
Calculated as the 
proportion of patients 
registered in mNavigator 
who completed 
treatment 
Data from mNavigator 
(outcome form) 
 
Time to diagnosis 
Continuous variable 
expressed as number of 
days and calculated as 
the difference between 
the diagnosis date and 
the registration date. 
Data from mNavigator 
(registration form; 
diagnosis form) 
 
System outcomes 
Usability  
System usability scale 
score ranging from 0-
100. A SUS score 
above a 68 is 
considered above 
average and anything 
below 68 is below 
average. 
10-point validated 
system usability scale 
 
Acceptability 
 
 
 
Usage 
Number of forms 
submitted, stratified, by 
users, per month of 
implementation 
Data from mNavigator 
(Mobile users statistics) 
 
 
Number of patients 
registered in 
mNavigator, per month 
of implementation 
Data from mNavigator 
(Mobile users statistics) 
 
Stability  
Number of instances of 
mNavigator failure per 
month 
 
Number of instances of 
CommCare failure per 
month 
 
Number of instances of 
device failure per month 
 
 
Implementation factors 
Training 
Number of hours of 
initial training as well as 
hours of ongoing 
support provided during 
the first month of 
implementation 
 
 
User-proficiency 
Number of users who 
are proficient in use of 
mNavigator within first 
month of 
implementation 
 
 
Time per form 
Average time in minutes 
spent completing each 
form, stratified by form 
 
 
Time per patient 
Average time in hours 
spent entering patient 
data in mNavigator, 
from time of registration 
 
 

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until an outcome is 
recorded. 
 
5.  Selection of Subjects: 
 
The following two groups of participants will be identified and screened for eligibility. 
 
BMC health professionals and staff 
We will approach approximately 15 BMC personnel, both who will directly use mNavigator and/or those 
whose work will be impacted by mNavigator, to offer enrollment in the study to help test usability of the 
mNavigator system prior to implementation and during implementation. BMC personnel will include health 
professionals who provide routine clinical care for pediatric cancer patients such as patient navigators, 
clinical coordinators, health providers and other clinical staff as well as non-clinical staff and other key 
stakeholders whose buy-in will be necessary for the successful implementation of mNavigator. 
 
Health professionals and staff will be identified to participate in this study based on the following inclusion 
criteria: 
• 
Must be a health provider or staff working at BMC who provide care or support clinical care for 
pediatric cancer patients at BMC (medical oncologists, radiation oncologists, nurses, patient 
navigators, clinical coordinators, among others). 
• 
Must be 18 years or older. 
 
Parents or caregivers and their child who is a BMC pediatric oncology patient with diagnosis of BL 
or Rb 
As part of standard of care, mNavigator will be used to register approximately 150 new BMC pediatric 
oncology patients yearly. Over the course of one year, we will enroll about 50 parents, for treatment 
management for the duration of treatment (typically 3 months for BL and 4 months for Rb) using mNavigator. 
 
Parents or caregivers and their children who are suspected or have known diagnosis of either BL or Rb will 
be identified to participate in this study based on the following inclusion criteria: 
• 
Child with suspected or known pediatric cancer diagnosis of either BL and Rb 
• 
Child younger than 18 years of age at enrollment 
 
6.  Subject Recruitment & Compensation: 
 
This study does not include DUHS patients. Recruitment will be limited to oncology health providers and 
staff, and pediatric patients and their parent or caregiver at the BMC cancer center.  
 
BMC health professionals and staff 
Research staff, with guidance from the PI working at BMC, will approach eligible BMC health professionals 
to offer enrollment in the study and introduce the study. The screening process to evaluate for eligibility will 
be conducted in a private setting prior to consent and enrollment. For health providers and staff, no 
identifying information will be collected prior to consent. However, we will keep a record of the number of 
providers and staff approached and, if applicable, reasons for ineligibility or refusal.  
 
Approximately 15 BMC health care providers and staff will be enrolled and consented into the study. Only 
those providing informed consent will be included in the study. Those who choose not to participate in the 
study will see no impact on their medical care and treatment, or their employment status or opportunities. 
 
Parents or caregivers and their child who is a BMC pediatric oncology patient with diagnosis of BL 
or Rb 
Research staff will reach out to parent/caregiver and pediatric patients who present with clinical diagnosis of 
pediatric cancer to the BMC Cancer Center. The screening process to evaluate for eligibility will be 
conducted in a private setting prior to consent and enrollment. No identifying information will be collected 
prior to consent. However, we will keep a record of the number of parents with a potentially eligible child are 
approached and, if applicable, reasons for ineligibility or refusal.  
 
Over the course of approximately a year, about 150 pediatric patients who present to BMC with a clinical 
diagnosis of pediatric cancer will be registered in mNavigator. Of those registered patients, approximately 50 
patients diagnosed with either Burkitt lymphoma (BL) or retinoblastoma (Rb) will be enrolled and consented 

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into the study. Only those providing informed consent will be included in the study. Those who choose not to 
participate in the study will see no impact on their medical care and treatment. 
 
Neither patients nor providers will receive any direct compensation for participation in the study. 
 
7.  Consent Process 
 
Who will conduct the consent process with prospective participants? 
Various research staff including study coordinator, research assistant, patient navigators and clinical 
coordinators will be trained to conduct the consent process. A PI may also consent. 
 
How much time will the prospective participant (or legally authorized representative) have between 
being approached about participating in the study and needing to decide whether or not to 
participate? 
 
Potential participants will be given time as needed to consider joining the study. However, in practical terms, 
patient’s parent or LAR will need to consent on the day of their BMC appointment. Patients will be asked to 
provide consent to have their patient information entered into mNavigator which will include patient 
registration information. Hence, the reason for requiring consent prior to registration. 
 
Patients will receive a copy of the consent with phone numbers of local investigator and local ethics boards 
printed, in case of questions.  
 
Where will the consent process occur? 
The consent/assent process will occur at Bugando Medical Centre, in a room or area where participants 
feel comfortable discussing the study. The consent process is expected to take approximately 10-15 
minutes. Participants will be encouraged to ask questions and will be given time needed to consider joining 
the study.  
 
What steps will be taken in that location to protect the privacy of the prospective participant? 
Patients will be consented as part of their normal clinic visit, after expressing interest to participate to their 
provider. The consent will be reviewed in an area of the health facility where the participant feel comfortable 
discussing the study. 
 
How much time will be allocated for conducting the initial consent discussion, including presenting 
the information in the consent document and answering questions, with each prospective 
participant? 
The informed consent process is expected to take approximately 15-20 minutes. During this time, 
participants will be encouraged to ask questions about the study. Before requesting participants' signature 
on the consent form, research staff will make every effort to ensure that the participants’ questions have 
been answered.  
 
The current study is limited to pediatric subjects under 18 years old and, therefore, consent will be obtained 
from a parent or LAR. Assent will be sought for children >12 years old. If still actively participating in this 
study, participants enrolled in this study as minors will be re-consented as adults when they turn 18 years 
old at the next available opportunity (i.e. next study visit, contact point, intervention). Re-consenting will 
occur at the next available opportunity (i.e. next study visit, contact point, intervention, etc.). 
 
If a child is older than 6 years old, research staff will ensure that the parent has had sufficient time to discuss 
the study with their child. If the child is older than 12, staff will ask the child to sign the consent as well. 
 
What arrangements will be in place for answering participant questions before and after the consent 
is signed? 
Informed consents for this study are in Swahili, with an English translation available. The Swahili versions 
are back-translated for accuracy. The informed consent process with all study participants will be conducted 
in Swahili. Written consent will be obtained from all participants. Health providers, staff and pediatric 
patients/parent/caregivers will be enrolled in the study only if they provide informed consent.  
 
Trained research staff will conduct the consent and assent process with participants to clearly explain study 
activities, and any risks and benefits associated with the study. Research staff will emphasize the voluntary 
nature of the study. They will inform participants that they may choose not to participate, or may stop 
participating at any time. They will also be instructed to look for signs of emotional distress or discomfort 

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during the consenting process, and to immediately stop if distress is noted. Research staff will also be 
advised to periodically pause for questions from participants. 
 
Participants will receive a copy of the consent form and will be directed to the phone numbers printed on the 
consent form for the local PI (Dr. Masalu) as well as contact information for the director of the ethics board at 
NIMR should any questions or concerns arise in the future. 
 
Describe the steps taken to minimize the possibility of coercion or undue influence. 
To minimize the possibility of coercion or undue influence, participants will be informed of all aspects of the 
study and any questions will be answered. The voluntary nature of the study will be emphasized. 
Participants will also be told that their decision to accept or decline participation in the study will not impact 
their ability to receive medical care and treatment provided by BMC, or their employment status or 
opportunities. A copy of the consent form will be provided to participants with a contact phone number to call 
in case they have questions or concerns about the study. 
 
What provisions will be in place to obtain consent from participants who do not read, are blind or 
who do not read/understand English? 
The consent process will be conducted in the local language, Swahili. For participants who are unable to 
read, research staff will read the consent form to the patients/parents/guardians and request a fingerprint 
instead of a signature in the presence of a literate witness. 
 
Swahili versions of the consent forms will be submitted to the Duke IRB once they have been approved by 
the NIMR IRB in Tanzania. 
 
 
8.  Subject’s Capacity to Give Legally Effective Consent: 
 
Since all patients enrolled in the study will be children younger than 18 years old, consent will be obtained 
from parent, guardian or caregiver. Assent will be sought for children who are 12 years old or older. After 
explaining the purpose of the study, as well as the process, consent will be obtained in writing or verbally 
(with thumbprint in the presence of a literate witness), depending on participant's literacy. Comprehension of 
the information provided will be ensured by asking potential participants if they completely understand the 
project aim and process. Research staff will also ask participants to repeat, in their own words, what they 
understand about the research study and how we are asking them to participate. These methods to ensure 
comprehension and avoid unintentional coercion will be taught to research staff prior to conducting any 
consents. 
 
9.  Study Interventions: 
 
Described in study activity section. 
 
10. Risk/Benefit Assessment: 
 
Risk  
BMC health professionals and staff 
Risks in this study are minimal as there are no physical risks from participation. There is always risk 
associated will loss of confidentiality for participants. However, this risk of loss of confidentiality will be 
minimized through rigorous training of study personnel, use of study identifiers to make data de-identified 
unless linked, and restricting access to identifiable data. 
 
Pediatric oncology patients and their parents or caregivers 
Risks in this study are minimal as there are no physical risks from participation. There is always risk 
associated will loss of confidentiality for participants. However, this risk of loss of confidentiality will be 
minimized through rigorous training of study personnel, use of study identifiers to make data de-identified 
unless linked, and restricting access to identifiable data. 
 
Receipt of treatment and any related risks for BL or Rb while participating in this study will be commensurate 
with receipt of standard of care treatment. Patient treatment will not be impacted if they choose to decline 
participation. 
  
Benefit 
BMC health professionals and staff 

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There are no direct benefits to to participants for taking part in the study. However, it is possible that by 
using mNavigator, providers will be able to better follow Tanzanian national guidelines related to pediatric 
cancer treatment. In addition, the information we get from observing and interviewing BMC health 
professionals and administrative staff may help us understand how mNavigator can work best in a setting 
like BMC to improve compliance with treatment protocols and increase treatment adherence thus improving 
survival outcomes in cancer patients. This may cause a sense of satisfaction in helping inform the better 
implementation of cancer treatment guidelines for better patient outcomes 
 
Pediatric oncology patients and their parents or caregivers 
A potential benefit of participation is that providers using mNavigator may follow national guidelines for 
treatment better, and so patients may receive treatment that is more consistent with national guidelines. 
Although this cannot be guaranteed, following national treatment guidelines are expected to improve the 
results of treatment. Additionally, we hope that in the future the information learned from this study will 
benefit other people with BL and Rb.   
 
11. Costs to the Subject:  
 
There are no costs to subject for participating in this study. 
 
12. Data Analysis & Statistical Considerations: 
 
Quantitative analysis plan:  
Descriptive statistical measures (e.g., means, proportions etc) will be used to describe basic socio-
demographic and clinical profiles of study participants. 
 
A compliance score will be generated based on the number of protocol steps completed.  
 
Difference-in-difference (DID) estimation will be used to track longitudinal differences in compliance from 
baseline to end line at BMC. For secondary outcomes, logistic regression will be used to assess provider 
characteristics associated with protocol compliance and completion of critical steps in the checklist. Patient 
characteristics at BMC will be compared using χ2 tests (binary variable) and t-tests (continuous variables). 
 
Qualitative analysis plan:  
For observations and in-depth interviews conducted with health providers and staff, we will use applied 
thematic analysis on the observation notes and interview transcripts. Electronic files may be uploaded into 
QSR NVivo--software that supports coding and finer level re-coding of text data that enables researchers to 
explore how concepts fit by developing and modifying a hierarchical coding index. Thematic analysis will be 
conducted via an iterative process of data collection and analysis that utilizes four interrelated steps: 
reading, coding, data display, and data reduction. The team will use a codebook of a priori, structural codes 
based on the observation and interview guides, and then a second round of coding, i.e. content coding, will 
be conducted to identify additional themes, ideas, or concepts. Twenty percent of transcripts will be coded 
by two team members to assess inter-rater reliability. Discussions will be held to resolve coding 
discrepancies. We may generate summaries of interviews and look across interviews for commonly named 
problems and solutions related to mNavigator. Data from the observations will be summarized as workflow 
diagrams, tables or other visual or narrative summaries to describe domains that help assess reach, 
efficacy, adoption, implementation, and technical functionality and stability. 
 
13. Data & Safety Monitoring:  
 
The current study does not alter standard of care therapy, but provides digital treatment algorithms to assist 
with following protocols. No additional adverse events are expected. Any unexpected adverse events from 
the digitalization of the treatment protocols will be reported by the mPIs, Drs. Vasudevan and Schroeder, to 
the DUMC and Tanzanian IRBs at BMC and the National Institute for Medical Research (NIMR). 
 
Investigators will make all study related documents, including consent forms, readily available for inspection 
by the study’s IRBs and authorized site monitors, including the Office for Human Research Protection 
(OHRP). On-site study monitoring will be performed by the principal investigators or their designees, to 
verify compliance with human subjects and other research regulations and guidelines; to assess adherence 
to the study protocol; and to confirm the quality and accuracy of information collected and entered into the 
study database. 
 

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The study will be conducted in full compliance with the protocol. With the exception of modifications required 
to eliminate immediate participant safety concerns, the protocol will not be amended without approval from 
the Duke principal investigators. Protocol amendments will be submitted to CUHAS, NIMR and Duke IRBs 
for approval prior to implementing amendments. 
 
14. Privacy, Data Storage & Confidentiality  
 
Explain how you will ensure that the subject's privacy will be protected: 
All participants will be approached by research staff to participate and, if they agree, will be consented in 
private area. Research staff will be trained to emphasize that participants can stop their participation at any 
time, refuse to answer any questions, and refuse to participate at the onset or during follow-up. 
 
Interviews, surveys and observations will be conducted in mutually agreed-upon locations, within the health 
facility. For group discussions/interviews or workshops such as during intervention development and pilot 
testing, participants will be reminded to keep proceedings confidential but also cautioned that anything that 
they say may be repeated by group members. 
 
Describe how research data will be stored and secured to ensure confidentiality: 
All enrolled participants will be assigned a study identification number (ID) to help protect their identity during 
data collection and analysis. Only study IDs will be used to identify participants’ medical record data, survey 
and interview responses. Enrollment logs, paper consents and contact information documentation sheets 
will have linkage information between study IDs and participant identifiable data. These will be stored 
separately from study materials identified only by ID. At Duke, only authorized research staff will view and 
monitor study logs, including enrollment logs, to keep track of participant recruitment and study progress. 
 
At both sites, locked filing cabinets will be used to keep paper study documents including informed consent 
forms, enrollment logs, paper data collection forms and other study documentation. At Duke, locked filing 
cabinets will be located in locked offices. Security staff members guard the BMC twenty-four hours a day. 
 
Enrollment logs will be stored separately from other record forms containing collected research data. 
Contact information will be stored and shared Qualtrics and/or CommCare.  
 
To enable the prospective tracking of participants, the study will collect identifying information such as 
names of patient (child and parent/caregiver) and provider/staff, dates of birth (only patients), home address 
and mobile phone numbers. Mobile phone numbers may be used to send reminders about upcoming 
appointments to parents, contact them about participation in follow-up survey/interview, and for other study-
related communication. This information will be stored on secure systems. 
 
All identifiable electronic data will reside in one or more of the HIPAA-compliant servers or devices 
and software used for this study at BMC and Duke, with appropriate network security measures in place. 
Secure applications and/or servers will be administered by BMC (in Tanzania), Dimagi, or Duke University 
(United States). Data will be kept in compliance with state and federal privacy regulations, including 
HIPAA. Qualtrics, REDCap, Box.com and CommCare are all HIPAA-compliant. REDCap (HIPAA-
compliant and secure – data are stored on DHTS servers behind Duke firewall). Permissions for the Box 
folder are provided centrally by Duke OIT and approved by the study PIs(s). User accounts and access will 
be provided to key personnel only upon approval by the mPIs.  
 
Electronic data may be transferred between BMC, and Duke via CommCare, Qualtrics, REDCap or Box.com 
and/or other secure software. A data transfer agreement (approved by NIMR) will govern the transfer of 
electronic data between BMC and Duke. Data transfer will occur via Qualtrics, REDCap, CommCare and/or 
a centrally administered Box account.  
 
PHI will be shared with Duke PI and research staff. These will include the following: 
• 
Names 
• 
Geographic subdivisions smaller that a state 
• 
Elements of dates directly related to the individual participant 
• 
Telephone numbers 
• 
Medical record data 
• 
Account numbers 
• 
Biometric identifiers such as voiceprints 
 

Research_Summary_20190226 
11 
 
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Sociodemographic, laboratory values and clinical features will be collected and stored within CommCare, 
whose data will be stored on a secure server. Health providers and research personnel will have access to 
this database. 
 
Due to the objectives of the study pertaining to pediatric cancer treatment care and compliance with 
treatment protocols as well as reduction in patient abandonment, we will collect the information on the year 
element of dates (birth dates, clinical care related dates etc.). In addition to the data listed in CommCare, we 
will also receive other data as described below: 
• 
Survey data collected on paper surveys and electronic devices. 
• 
Voice recordings and/or transcripts of group discussions/interviews and in-depth interviews 
• 
Medical data for enrolled participants including clinical care dates, values, results, notes 
• 
Recruitment, enrollment, patient tracking logbooks 
• 
Administrative data from health facilities or district/regional administration 
 
Research staff will sign a confidentiality agreement. Only information about groups of participants will be 
written and published, and it will not be possible to identify any one person when study results are 
published.  
 
 
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