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Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment
NA trial testing mNavigator in Burkitt Lymphoma in 75 participants. Completed in 22 April 2022.
| Lead sponsor | Duke University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 75 |
| Start date | 23 July 2019 |
| Primary completion | 22 April 2022 |
| Estimated completion | 22 April 2022 |
| Sites | 1 location across Tanzania |
Duke University
Eligibility, any sex, with Burkitt Lymphoma or Retinoblastoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| mNavigator - Burkitt Lymphoma (BL) | 73.8 | ± 15.1 |
| mNavigator - Retinoblastoma (Rb) | 96.0 | ± 5.1 |
| Historical Controls - Burkitt Lymphoma (BL) | 50.0 | ± 16.0 |
| Historical Controls - Retinoblastoma (Rb) | 74.9 | ± 11.9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| mNavigator - Burkitt Lymphoma (BL) | 0 | ± 3.3 |
| mNavigator - Retinoblastoma (Rb) | 0 | ± 0.5 |
| Historical Controls - Burkitt Lymphoma (BL) | 5 | ± 145.9 |
| Historical Controls - Retinoblastoma (Rb) | 0 | ± 1.0 |
Treatment abandonment is defined as missing 4 or more consecutive weeks of treatment or follow-up while on therapy.
| Group | Value | 95% CI |
|---|---|---|
| mNavigator - Burkitt Lymphoma (BL) | 9 | |
| mNavigator - Retinoblastoma (Rb) | 5 | |
| Historical Controls - Burkitt Lymphoma (BL) | 25 | |
| Historical Controls - Retinoblastoma (Rb) | 18 |
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).
| Group | Value | 95% CI |
|---|---|---|
| mNavigator - Burkitt Lymphoma (BL) | 23 | |
| mNavigator - Retinoblastoma (Rb) | 10 | |
| Historical Controls - Burkitt Lymphoma (BL) | 25 | |
| Historical Controls - Retinoblastoma (Rb) | 3 |
| Group | Value | 95% CI |
|---|---|---|
| mNavigator Users | 0 | ± 0 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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