Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03677128 |
| Other study ID # |
Pro00094010 |
| Secondary ID |
1R21CA217268-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 23, 2019 |
| Est. completion date |
April 22, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Digital case management systems have the potential to increase compliance with
protocol-driven treatment, reduce treatment abandonment and ultimately help to close the
discrepancy in pediatric cancer outcomes between Low and Middle Income Countries (LMICs) and
high-income countries (HICs). The investigators aim to adapt an open-source digital case
management platform to incorporate standardized pediatric oncology protocols. Effectiveness
will be evaluated by provider protocol compliance (primary outcome) and patient treatment
abandonment rates using the digital case management system as compared to historic controls.
The study population will include patients diagnosed with Burkitt lymphoma, Diffuse large
B-cell lymphoma (DLBCL) or retinoblastoma at Bugando Medical Centre in Tanzania.
Description:
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). 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, 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. Digital
technologies for health (i.e., digital health) 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.).
This multidisciplinary team from Duke University and Dimagi Inc. in USA, and Bugando Medical
Centre (BMC) in Tanzania, proposes to adapt, implement, and evaluate a digital case
management system, called mNavigator, at BMC to improve health provider compliance with
standardized pediatric oncology protocols.
For Aim 1, mNavigator development will initially focus on the two nationally-approved
protocols for Burkitt lymphoma and retinoblastoma. The treatment for Diffuse large B-cell
lymphoma (DLBCL) follows the Burkitt lymphoma treatment protocol. Using principles of
persuasive system design and the Consolidated Framework for Implementation Research (CFIR),
prompts that guide users through protocol implementation will be used as behavioral triggers
to assist with perceived ease of use.
For Aim 2, allied health providers at BMC will receive training on using mNavigator as part
of an in-country workshop led by the M-PIs. This training will be followed by supported
implementation. Following this training period, mNavigator will be used to enroll pediatric
patients at BMC with pre-clinical diagnosis of BL, Diffuse large B-cell lymphoma (DLBCL) or
Rb, over a period of over one and a half years and manage their care for the duration of
treatment (up to 3 months for BL and DLBCL, and 4 months for Rb). BMC receives and treats
approximately 150 patients every year, with an estimated 50 patients annually with Burkitt
lymphoma (BL), Diffuse large B-cell lymphoma (DLBCL) or Rb. To review historic compliance,
files of patients diagnosed after 2015 with BL, Diffuse large B-cell lymphoma (DLBCL) and Rb
(when protocols were introduced) will be abstracted by trained research assistants.
Compliance with protocol-driven treatment will be monitored using mNavigator. System
functionality will be assessed. Semi-structured assessments of provider system acceptance and
usability will be conducted along with elucidating caregiver reported barriers to treatment
completion.
Secondary objective is to describe factors that facilitate or inhibit implementation of
mNavigator.
