Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03677128
Recruitment Status : Not yet recruiting
First Posted : September 19, 2018
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

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 or retinoblastoma at Bugando Medical Centre in Tanzania.

Condition or disease Intervention/treatment Phase
Burkitt Lymphoma Retinoblastoma Other: mNavigator Not Applicable

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 Center (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. 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 or Rb, over a period of 1 year and manage their care for the duration of treatment (up to 3 months for BL and 4 months for Rb). BMC receives and treats approximately 150 patients every year, with an estimated 50 patients with Burkitt lymphoma (BL) and Rb. To review historic compliance, files of patients diagnosed after 2015 with BL 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Effects on outcomes when using mNaviagtor 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)
Primary Purpose: Health Services Research
Official Title: A Mobile Health (mHealth) Case Management System for Reducing Pediatric Cancer Treatment Abandonment
Estimated Study Start Date : July 31, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021


Arm Intervention/treatment
Experimental: mNavigator
Allied health providers will use mNavigator to guide diagnosis and treatment for pediatric cancer patients at Bugando Medical Centre (BMC).
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 or retinoblastoma.

No Intervention: Historical controls
BL/Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL and Rb were introduced at BMC.



Primary Outcome Measures :
  1. Protocol compliance [ Time Frame: Approximately 1 year ]
    Percentage difference in protocol compliance with mNavigator and historical compliance.


Secondary Outcome Measures :
  1. Time to diagnosis (in days) [ Time Frame: Approximately 1 year ]
    The number of days to diagnosis using mNavigator compared to historical controls. Time to diagnosis is computed as the duration (in days) from registration to diagnosis.

  2. Treatment abandonment [ Time Frame: Approximately 1 year ]
    Calculated as the difference in proportion of patients registered in mNavigator who abandon treatment compared to historical controls who abandon treatment. Treatment abandonment is defined as missing 4 or more consecutive weeks of treatment or follow-up while on therapy.

  3. Treatment completion [ Time Frame: Approximately 1 year ]
    Calculated as the proportion of patients registered in mNavigator who completed treatment (excludes patient deaths).

  4. System usability scale score [ Time Frame: Approximately 1 year ]
    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.

  5. Monthly utilization of mNavigator [ Time Frame: Approximately 1 year ]
    Number of forms submitted using mNavigator, stratified, by users, per month of implementation.

  6. Number of patients registered in mNavigator during study period [ Time Frame: Approximately 1 year ]
    Number of patients registered in mNavigator during study period

  7. Number of instances of mNavigator failure per month (all-causes) [ Time Frame: Approximately 1 year ]
    Number of instances of mNavigator failure per month (all-causes)

  8. Number of instances of CommCare failure per month (all-causes) [ Time Frame: Approximately 1 year ]
    Number of instances of CommCare failure per month (all-causes)

  9. Number of instances of device failure per month (all-causes) [ Time Frame: Approximately 1 year ]
    Number of instances of device failure per month (all-causes)

  10. 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 ]
    Number of hours of initial training as well as hours of ongoing support provided during the first month of implementation

  11. Number of users who are proficient in use of mNavigator within first month of implementation [ Time Frame: Approximately 1 year ]
    Number of users who are proficient in use of mNavigator within first month of implementation

  12. Average time in minutes spent completing each form, stratified by form [ Time Frame: Approximately 1 year ]
    Average time in minutes spent completing each form, stratified by form

  13. Time per patient [ Time Frame: Approximately 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

There are two categories of participants: Patients with Burkitt 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 or RB once the diagnosis is made.

Inclusion Criteria:

  • Inclusion criteria are pediatric oncology patients diagnosed with Burkitt Lymphoma or Retinoblastoma under the age of 18

Exclusion criteria:

  • Patients older than 18 years at registration
  • Patients with diagnoses other than Burkitt 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677128


Contacts
Layout table for location contacts
Contact: Christina Makarushka, MPH 919-613-0154 christina.makarushka@duke.edu
Contact: Kristin Schroeder, MD MPH kristin.schroeder@duke.edu

Locations
Layout table for location information
Tanzania
Bugando Medical Centre Not yet recruiting
Mwanza, Lake Zone, Tanzania
Contact: Nestory Masalu, MD         
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Kristin Schroeder, MD MPH Duke University
Principal Investigator: Lavanya Vasudevan, PhD Duke University

Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03677128     History of Changes
Other Study ID Numbers: Pro00094010
1R21CA217268-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Burkitt Lymphoma
Retinoblastoma
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
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