Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment

NCT ID: NCT03677128

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-23
• Study Completion Date: 2022-04-22

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.

Conditions

Burkitt Lymphoma; Retinoblastoma; Diffuse Large B-cell Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

mNavigator

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

Group Type: EXPERIMENTAL

mNavigator

Intervention Type: 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.

Historical controls

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 or retinoblastoma.

Intervention Type: OTHER

Eligibility Criteria

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.

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:

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Schroeder, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Lavanya Vasudevan, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Bugando Medical Centre

Mwanza, Lake Zone, Tanzania

Countries

Tanzania

References

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.

Reference Type: DERIVED

PMID: 32223740 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R21CA217268-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00094010

Identifier Type: -

Identifier Source: org_study_id