N/A N=167 Health Services Research

Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment

Burkitt Lymphoma · Retinoblastoma · Diffuse Large B-cell Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT03677128 ↗

Enrolled (actual)

167

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy — 73.8; 96.0; 50.0; 74.9 percentage of compliance — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: mNavigator (Other)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Duke University
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy	73.8; 96.0; 50.0; 74.9	<0.001 sig
SECONDARY Time to Diagnosis (in Days)	0; 0; 5; 0	—
SECONDARY Number of Participants Who Abandon Treatment	9; 5; 25; 18	—
SECONDARY Number of Participants Who Completed Treatment as Indicated	23; 10; 25; 3	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03677128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.