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Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment

A Mobile Health (mHealth) Case Management System for Reducing Pediatric Cancer Treatment Abandonment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03677128
Enrollment
75
Registered
2018-09-19
Start date
2019-07-23
Completion date
2022-04-22
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burkitt Lymphoma, Diffuse Large B-cell Lymphoma, Retinoblastoma

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

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.

Interventions

OTHERmNavigator

Allied health providers at BMC will use mNavigator to facilitate compliance with protocol-driven treatment and reduce patient abandonment for patients diagnosed with Burkitt lymphoma, Diffuse large B-cell lymphoma or retinoblastoma.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
Protocol Compliance as Measured by Percent Compliance to Prescribed ChemotherapyApproximately 1 year

Secondary

MeasureTime frameDescription
Time to Diagnosis (in Days)Approximately 1 yearThe number of days to diagnosis using mNavigator compared to historical controls. Time to diagnosis is computed as the duration (in days) from registration at oncology clinic to confirmatory diagnosis. If diagnosis was determined prior to intake, 0 days was entered.
Number of Participants Who Abandon TreatmentApproximately 1 yearTreatment abandonment is defined as missing 4 or more consecutive weeks of treatment or follow-up while on therapy.
Number of Participants Who Completed Treatment as IndicatedApproximately 1 year after treatment initiationPatients registered in mNavigator who completed treatment as indicated (excludes patient deaths or abandoned care without returning, treatment failure, and Rb patients who should have enucleation per protocol but did not complete).

Other

MeasureTime frameDescription
Number of Instances of Device Failure Per Month (All-causes)Approximately 1 yearNumber of instances of device failure per month (all-causes)
Number of Hours of Initial Training as Well as Hours of Ongoing Support Provided During the First Month of ImplementationApproximately 1 yearNumber of hours of initial training as well as hours of ongoing support provided during the first month of implementation
System Usability Scale ScoreApproximately 1 yearSystem usability scale (SUS) score ranging from 0-100 measured using a 10-point validated system usability scale. A SUS score above 68 is considered above average usability.
Average Time in Minutes Spent Completing Each Form, Stratified by FormApproximately 1 yearAverage time in minutes spent completing each form, stratified by form
Time Per PatientApproximately 1 yearTotal time in minutes spent entering patient data in mNavigator, from time of registration until an outcome is recorded. Calculated by summing time for completing each form, by patient.
Number of Users Who Are Proficient in Use of mNavigator Within First Month of ImplementationApproximately 1 yearNumber of users who are proficient in use of mNavigator within first month of implementation
Monthly Utilization of mNavigatorApproximately 1 yearNumber of forms submitted using mNavigator, stratified, by users, per month of implementation.
Number of Instances of mNavigator Failure Per Month (All-causes)Approximately 1 year
Number of Instances of CommCare Failure Per Month (All-causes)Approximately 1 yearNumber of instances of CommCare failure per month (all-causes)

Countries

Tanzania

Participant flow

Recruitment details

Recruitment occurred July 2019 - April 2022. Due to COVID-19, in March 2020, the National Institute of Medical Research in Tanzania paused all clinical research activities in the country, stopping new enrollment until research activities resumed in August 2020.

Pre-assignment details

Historical control patients were not considered enrolled, but historical control data was used as a comparison, so is included here. mNavigator users were also not considered enrolled, but provided data.

Participants by arm

ArmCount
mNavigator - Burkitt Lymphoma (BL)
Prospective cohort of patients diagnosed with BL where allied health providers used mNavigator to guide diagnosis and treatment at Bugando Medical Centre (BMC). mNavigator: Allied health providers at BMC will use mNavigator to facilitate compliance with protocol-driven treatment and reduce patient abandonment for patients diagnosed with Burkitt lymphoma, Diffuse large B-cell lymphoma (DLBCL) or retinoblastoma.
36
mNavigator - Retinoblastoma (Rb)
Prospective cohort of patients diagnosed with Rb where allied health providers used mNavigator to guide diagnosis and treatment at Bugando Medical Centre (BMC). mNavigator: Allied health providers at BMC will use mNavigator to facilitate compliance with protocol-driven treatment and reduce patient abandonment for patients diagnosed with Burkitt lymphoma, Diffuse large B-cell lymphoma (DLBCL) or retinoblastoma.
16
Historical Controls - Burkitt Lymphoma (BL)
BL retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC).
63
Historical Controls - Retinoblastoma (Rb)
Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC).
25
mNavigator Users
Health care providers using mNavigator
0
Total140

Baseline characteristics

CharacteristicmNavigator - Burkitt Lymphoma (BL)TotalHistorical Controls - Retinoblastoma (Rb)Historical Controls - Burkitt Lymphoma (BL)mNavigator - Retinoblastoma (Rb)
Age, Continuous8.2 years
STANDARD_DEVIATION 4.3
5.95 years
STANDARD_DEVIATION 3.39
3.3 years
STANDARD_DEVIATION 1.6
9.5 years
STANDARD_DEVIATION 4
2.8 years
STANDARD_DEVIATION 1.6
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
36 Participants140 Participants25 Participants63 Participants16 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
36 Participants140 Participants25 Participants63 Participants16 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
Tanzania
36 Participants140 Participants25 Participants63 Participants16 Participants
Sex: Female, Male
Female
9 Participants55 Participants12 Participants27 Participants7 Participants
Sex: Female, Male
Male
27 Participants85 Participants13 Participants36 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 460 / 290 / 00 / 00 / 0
other
Total, other adverse events
0 / 460 / 290 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 460 / 290 / 00 / 00 / 0

Outcome results

Primary

Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy

Time frame: Approximately 1 year

Population: Participants who completed the study and historical controls. Does not apply to mNavigator Users.

ArmMeasureValue (MEAN)Dispersion
mNavigator - Burkitt Lymphoma (BL)Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy73.8 percentage of complianceStandard Deviation 15.1
mNavigator - Retinoblastoma (Rb)Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy96.0 percentage of complianceStandard Deviation 5.1
Historical Controls - Burkitt Lymphoma (BL)Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy50.0 percentage of complianceStandard Deviation 16
Historical Controls - Retinoblastoma (Rb)Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy74.9 percentage of complianceStandard Deviation 11.9
p-value: <0.001Kruskal-Wallis
p-value: <0.001Kruskal-Wallis
Secondary

Number of Participants Who Abandon Treatment

Treatment abandonment is defined as missing 4 or more consecutive weeks of treatment or follow-up while on therapy.

Time frame: Approximately 1 year

Population: Participants who completed the study and historical controls. Does not apply to mNavigator Users.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mNavigator - Burkitt Lymphoma (BL)Number of Participants Who Abandon Treatment9 Participants
mNavigator - Retinoblastoma (Rb)Number of Participants Who Abandon Treatment5 Participants
Historical Controls - Burkitt Lymphoma (BL)Number of Participants Who Abandon Treatment25 Participants
Historical Controls - Retinoblastoma (Rb)Number of Participants Who Abandon Treatment18 Participants
Secondary

Number of Participants Who Completed Treatment as Indicated

Patients registered in mNavigator who completed treatment as indicated (excludes patient deaths or abandoned care without returning, treatment failure, and Rb patients who should have enucleation per protocol but did not complete).

Time frame: Approximately 1 year after treatment initiation

Population: Participants who completed the study and historical controls. Does not apply to mNavigator Users.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
mNavigator - Burkitt Lymphoma (BL)Number of Participants Who Completed Treatment as Indicated23 Participants
mNavigator - Retinoblastoma (Rb)Number of Participants Who Completed Treatment as Indicated10 Participants
Historical Controls - Burkitt Lymphoma (BL)Number of Participants Who Completed Treatment as Indicated25 Participants
Historical Controls - Retinoblastoma (Rb)Number of Participants Who Completed Treatment as Indicated3 Participants
Secondary

Time to Diagnosis (in Days)

The number of days to diagnosis using mNavigator compared to historical controls. Time to diagnosis is computed as the duration (in days) from registration at oncology clinic to confirmatory diagnosis. If diagnosis was determined prior to intake, 0 days was entered.

Time frame: Approximately 1 year

Population: Participants who completed the study and historical controls. Does not apply to mNavigator Users.

ArmMeasureValue (MEDIAN)Dispersion
mNavigator - Burkitt Lymphoma (BL)Time to Diagnosis (in Days)0 daysStandard Deviation 3.3
mNavigator - Retinoblastoma (Rb)Time to Diagnosis (in Days)0 daysStandard Deviation 0.5
Historical Controls - Burkitt Lymphoma (BL)Time to Diagnosis (in Days)5 daysStandard Deviation 145.9
Historical Controls - Retinoblastoma (Rb)Time to Diagnosis (in Days)0 daysStandard Deviation 1
Other Pre-specified

Average Time in Minutes Spent Completing Each Form, Stratified by Form

Average time in minutes spent completing each form, stratified by form

Time frame: Approximately 1 year

Other Pre-specified

Monthly Utilization of mNavigator

Number of forms submitted using mNavigator, stratified, by users, per month of implementation.

Time frame: Approximately 1 year

Other Pre-specified

Number of Hours of Initial Training as Well as Hours of Ongoing Support Provided During the First Month of Implementation

Number of hours of initial training as well as hours of ongoing support provided during the first month of implementation

Time frame: Approximately 1 year

Other Pre-specified

Number of Instances of CommCare Failure Per Month (All-causes)

Number of instances of CommCare failure per month (all-causes)

Time frame: Approximately 1 year

Other Pre-specified

Number of Instances of Device Failure Per Month (All-causes)

Number of instances of device failure per month (all-causes)

Time frame: Approximately 1 year

Other Pre-specified

Number of Instances of mNavigator Failure Per Month (All-causes)

Time frame: Approximately 1 year

Population: Only applies to mNavigator Users.

ArmMeasureValue (MEAN)Dispersion
mNavigator - Burkitt Lymphoma (BL)Number of Instances of mNavigator Failure Per Month (All-causes)0 failures per monthStandard Deviation 0
Other Pre-specified

Number of Users Who Are Proficient in Use of mNavigator Within First Month of Implementation

Number of users who are proficient in use of mNavigator within first month of implementation

Time frame: Approximately 1 year

Other Pre-specified

System Usability Scale Score

System usability scale (SUS) score ranging from 0-100 measured using a 10-point validated system usability scale. A SUS score above 68 is considered above average usability.

Time frame: Approximately 1 year

Other Pre-specified

Time Per Patient

Total time in minutes spent entering patient data in mNavigator, from time of registration until an outcome is recorded. Calculated by summing time for completing each form, by patient.

Time frame: Approximately 1 year

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026