Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment

NCT03677128 | Completed Results

• 2 other identifiers: Pro000940101R21CA217268-01A1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy

  Approximately 1 year

Secondary Outcomes (3)

• Time to Diagnosis (in Days)

  Approximately 1 year

• Number of Participants Who Abandon Treatment

  Approximately 1 year

• Number of Participants Who Completed Treatment as Indicated

  Approximately 1 year after treatment initiation

Other Outcomes (9)

• System Usability Scale Score

  Approximately 1 year

• Monthly Utilization of mNavigator

  Approximately 1 year

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

  Approximately 1 year

Study Arms (2)

mNavigator

EXPERIMENTAL

Allied health providers will use mNavigator to guide diagnosis and treatment for pediatric cancer patients at Bugando Medical Centre (BMC).

Other: mNavigator

Historical controls

NO INTERVENTION

BL (DLBCL)/Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at BMC.

Interventions

mNavigator OTHER

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.

mNavigator

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients older than 18 years at registration
• Patients with diagnoses other than Burkitt lymphoma, Diffuse large B-cell lymphoma or retinoblastoma.
• B) For providers:
• Must be health provider or staff working at BMC who provides care for cancer patients.
• Must be 18 years of age or older.
• \- Persons younger than 18 years of age.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Bugando Medical Centre

Mwanza, Lake Zone, Tanzania

Location

Related Publications (1)

• 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.

  PMID: 32223740 DERIVED

MeSH Terms

Conditions

Burkitt Lymphoma; Retinoblastoma; Lymphoma, Large B-Cell, Diffuse; Neoplasms

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Results Point of Contact

• Title: Kristin Schroeder, MD MPH
• Organization: Duke University

kristin.schroeder@duke.edu

919-668-6288

Study Officials

• Kristin Schroeder, MD MPH

  Duke University

  PRINCIPAL INVESTIGATOR

• Lavanya Vasudevan, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: September 19, 2018
• Study Start: July 23, 2019
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: May 9, 2023
• Results First Posted: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)