Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677128
• Other study ID #: Pro00094010
• Secondary ID: 1R21CA217268-01A
• Status: Completed
• Phase: N/A
• Start date: July 23, 2019
• Est. completion date: April 22, 2022

Study information

• Verified date: April 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 22, 2022
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Burkitt Lymphoma
• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Retinoblastoma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Tanzania	Bugando Medical Centre	Mwanza	Lake Zone

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Approximately 1 year
Other	Monthly Utilization of mNavigator	Number of forms submitted using mNavigator, stratified, by users, per month of implementation.	Approximately 1 year
Other	Number of Instances of mNavigator Failure Per Month (All-causes)		Approximately 1 year
Other	Number of Instances of CommCare Failure Per Month (All-causes)	Number of instances of CommCare failure per month (all-causes)	Approximately 1 year
Other	Number of Instances of Device Failure Per Month (All-causes)	Number of instances of device failure per month (all-causes)	Approximately 1 year
Other	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	Approximately 1 year
Other	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	Approximately 1 year
Other	Average Time in Minutes Spent Completing Each Form, Stratified by Form	Average time in minutes spent completing each form, stratified by form	Approximately 1 year
Other	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.	Approximately 1 year
Primary	Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy		Approximately 1 year
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.	Approximately 1 year
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.	Approximately 1 year
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).	Approximately 1 year after treatment initiation