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Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment

Primary Purpose

Burkitt Lymphoma, Retinoblastoma, Diffuse Large B-cell Lymphoma

Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
mNavigator
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Burkitt Lymphoma focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bugando Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mNavigator

Historical controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
August 21, 2018
Last Updated
April 14, 2023
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03677128
Brief Title
Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment
Official Title
A Mobile Health (mHealth) Case Management System for Reducing Pediatric Cancer Treatment Abandonment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 23, 2019 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
April 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mNavigator
Arm Type
Experimental
Arm Description
Allied health providers will use mNavigator to guide diagnosis and treatment for pediatric cancer patients at Bugando Medical Centre (BMC).
Arm Title
Historical controls
Arm Type
No Intervention
Arm Description
BL (DLBCL)/Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at BMC.
Intervention Type
Other
Intervention Name(s)
mNavigator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy
Time Frame
Approximately 1 year
Secondary Outcome Measure Information:
Title
Time to Diagnosis (in Days)
Description
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.
Time Frame
Approximately 1 year
Title
Number of Participants Who Abandon Treatment
Description
Treatment abandonment is defined as missing 4 or more consecutive weeks of treatment or follow-up while on therapy.
Time Frame
Approximately 1 year
Title
Number of Participants Who Completed Treatment as Indicated
Description
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).
Time Frame
Approximately 1 year after treatment initiation
Other Pre-specified Outcome Measures:
Title
System Usability Scale Score
Description
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.
Time Frame
Approximately 1 year
Title
Monthly Utilization of mNavigator
Description
Number of forms submitted using mNavigator, stratified, by users, per month of implementation.
Time Frame
Approximately 1 year
Title
Number of Instances of mNavigator Failure Per Month (All-causes)
Time Frame
Approximately 1 year
Title
Number of Instances of CommCare Failure Per Month (All-causes)
Description
Number of instances of CommCare failure per month (all-causes)
Time Frame
Approximately 1 year
Title
Number of Instances of Device Failure Per Month (All-causes)
Description
Number of instances of device failure per month (all-causes)
Time Frame
Approximately 1 year
Title
Number of Hours of Initial Training as Well as Hours of Ongoing Support Provided During the First Month of Implementation
Description
Number of hours of initial training as well as hours of ongoing support provided during the first month of implementation
Time Frame
Approximately 1 year
Title
Number of Users Who Are Proficient in Use of mNavigator Within First Month of Implementation
Description
Number of users who are proficient in use of mNavigator within first month of implementation
Time Frame
Approximately 1 year
Title
Average Time in Minutes Spent Completing Each Form, Stratified by Form
Description
Average time in minutes spent completing each form, stratified by form
Time Frame
Approximately 1 year
Title
Time Per Patient
Description
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.
Time Frame
Approximately 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Schroeder, MD MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lavanya Vasudevan, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bugando Medical Centre
City
Mwanza
State/Province
Lake Zone
Country
Tanzania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32223740
Citation
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.
Results Reference
derived

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Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment

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