Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment

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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

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.

Study Type

Interventional

Primary Outcome

Protocol compliance

Secondary Outcome

 Time to diagnosis (in days)

Condition

Burkitt Lymphoma

Intervention

mNavigator

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

95

Start Date

July 23, 2019

Completion Date

July 31, 2022

Primary Completion Date

July 31, 2022

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.

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Kristin Schroeder, MD MPH, ,

Location Countries

Tanzania

Location Countries

Tanzania

Administrative Informations

NCT ID

NCT03677128

Organization ID

Pro00094010

Secondary IDs

1R21CA217268-01A1

Responsible Party

Sponsor

Study Sponsor

Duke University

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Kristin Schroeder, MD MPH, Principal Investigator, Duke University

Verification Date

March 2022