Clinical trial NCT03677128: Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment
Official title: A Mobile Health (mHealth) Case Management System for Reducing Pediatric Cancer Treatment Abandonment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burkitt Lymphoma
Retinoblastoma
Diffuse Large B-cell Lymphoma
Keywords: Digital Health
Pediatric Cancer
Low and middle-income country
Tanzania
Healthcare provider decision support
Protocol-driven treatment
Burkitt lymphoma
Retinoblastoma
Treatment abandonment
Client health records
Diffuse large B-cell lymphoma
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-09-19
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Effects on outcomes when using mNavigator will be compared to historical controls (preceding mNavigator use). Number of participants below references those who will be consented prospectively to participate in the study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: There are two categories of participants: Patients with Burkitt Lymphoma, Diffuse large B-cell lymphoma or retinoblastoma; and health providers at BMC who participate in testing and/or use of mNavigator. Eligibility criteria are as follows:

A) For patients:

\*All patients will be registered in the pre-diagnosis cohort but, for the purposes of this study, primary and secondary outcomes will only be tracked for patients with BL, DLBCL or RB once the diagnosis is made.

Inclusion Criteria:

* Inclusion criteria are pediatric oncology patients diagnosed with Burkitt Lymphoma, Diffuse large B-cell lymphoma or Retinoblastoma under the age of 18

Exclusion criteria:

* Patients older than 18 years at registration
* Patients with diagnoses other than Burkitt lymphoma, Diffuse large B-cell lymphoma or retinoblastoma.

B) For providers:

Inclusion Criteria:

* Must be health provider or staff working at BMC who provides care for cancer patients.
* Must be 18 years of age or older.

Exclusion:

- Persons younger than 18 years of age.

Primary outcomes:
measure: Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy
timeFrame: Approximately 1 year
Secondary outcomes:
measure: Time to Diagnosis (in Days)
timeFrame: Approximately 1 year
measure: Number of Participants Who Abandon Treatment
timeFrame: Approximately 1 year
measure: Number of Participants Who Completed Treatment as Indicated
timeFrame: Approximately 1 year after treatment initiation
Other outcomes:
measure: System Usability Scale Score
timeFrame: Approximately 1 year
measure: Monthly Utilization of mNavigator
timeFrame: Approximately 1 year
measure: Number of Instances of mNavigator Failure Per Month (All-causes)
timeFrame: Approximately 1 year
measure: Number of Instances of CommCare Failure Per Month (All-causes)
timeFrame: Approximately 1 year
measure: Number of Instances of Device Failure Per Month (All-causes)
timeFrame: Approximately 1 year
measure: Number of Hours of Initial Training as Well as Hours of Ongoing Support Provided During the First Month of Implementation
timeFrame: Approximately 1 year
measure: Number of Users Who Are Proficient in Use of mNavigator Within First Month of Implementation
timeFrame: Approximately 1 year
measure: Average Time in Minutes Spent Completing Each Form, Stratified by Form
timeFrame: Approximately 1 year
measure: Time Per Patient
timeFrame: Approximately 1 year
Locations:
city: Mwanza
country: Tanzania
facility: Bugando Medical Centre
state: Lake Zone
Study officials:
affiliation: Duke University
name: Kristin Schroeder, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Lavanya Vasudevan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vasudevan L, Schroeder K, Raveendran Y, Goel K, Makarushka C, Masalu N, Zullig LL. Using digital health to facilitate compliance with standardized pediatric cancer treatment guidelines in Tanzania: protocol for an early-stage effectiveness-implementation hybrid study. BMC Cancer. 2020 Mar 29;20(1):254. doi: 10.1186/s12885-020-6611-3.