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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA217268-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mNavigator | Experimental | Allied health providers will use mNavigator to guide diagnosis and treatment for pediatric cancer patients at Bugando Medical Centre (BMC). |
|
| Historical controls | No Intervention | BL (DLBCL)/Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at BMC. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mNavigator | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy | Approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Monthly Utilization of mNavigator |
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:
Exclusion criteria:
B) For providers:
Inclusion Criteria:
Exclusion:
- Persons younger than 18 years of age.
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Schroeder, MD MPH | Duke University | Principal Investigator |
| Lavanya Vasudevan, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bugando Medical Centre | Mwanza | Lake Zone | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32223740 | Derived | 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. |
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Historical control patients were not considered enrolled, but historical control data was used as a comparison, so is included here. mNavigator users were also not considered enrolled, but provided data.
Recruitment occurred July 2019 - April 2022. Due to COVID-19, in March 2020, the National Institute of Medical Research in Tanzania paused all clinical research activities in the country, stopping new enrollment until research activities resumed in August 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | mNavigator - Burkitt Lymphoma (BL) | Prospective cohort of patients diagnosed with BL where allied health providers used mNavigator to guide diagnosis and treatment at Bugando Medical Centre (BMC). 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 (DLBCL) or retinoblastoma. |
| FG001 | mNavigator - Retinoblastoma (Rb) | Prospective cohort of patients diagnosed with Rb where allied health providers used mNavigator to guide diagnosis and treatment at Bugando Medical Centre (BMC). 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 (DLBCL) or retinoblastoma. |
| FG002 | Historical Controls - Burkitt Lymphoma (BL) | BL retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC). |
| FG003 | Historical Controls - Retinoblastoma (Rb) | Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC). |
| FG004 | mNavigator Users | Health care providers using mNavigator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who completed the study. Baseline Characteristics not collected on mNavigator Users.
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| ID | Title | Description |
|---|---|---|
| BG000 | mNavigator - Burkitt Lymphoma (BL) | Prospective cohort of patients diagnosed with BL where allied health providers used mNavigator to guide diagnosis and treatment at Bugando Medical Centre (BMC). 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 (DLBCL) or retinoblastoma. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy | Participants who completed the study and historical controls. Does not apply to mNavigator Users. | Posted | Mean | Standard Deviation | percentage of compliance | Approximately 1 year |
|
Approximately 1 year from treatment initiation
Adverse Event data not collected on historical controls or mNavigator users.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | mNavigator - Burkitt Lymphoma (BL) | Prospective cohort of patients diagnosed with BL where allied health providers used mNavigator to guide diagnosis and treatment at Bugando Medical Centre (BMC). 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 (DLBCL) or retinoblastoma. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristin Schroeder, MD MPH | Duke University | 919-668-6288 | kristin.schroeder@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2019 | Apr 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D012175 | Retinoblastoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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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.
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| 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 |
| 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 |
Number of forms submitted using mNavigator, stratified, by users, per month of implementation. |
| Approximately 1 year |
| Number of Instances of mNavigator Failure Per Month (All-causes) | Approximately 1 year |
| Number of Instances of CommCare Failure Per Month (All-causes) | Number of instances of CommCare failure per month (all-causes) | Approximately 1 year |
| Number of Instances of Device Failure Per Month (All-causes) | Number of instances of device failure per month (all-causes) | Approximately 1 year |
| 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 |
| 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 |
| 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 |
| 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 |
| BG001 | mNavigator - Retinoblastoma (Rb) | Prospective cohort of patients diagnosed with Rb where allied health providers used mNavigator to guide diagnosis and treatment at Bugando Medical Centre (BMC). 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 (DLBCL) or retinoblastoma. |
| BG002 | Historical Controls - Burkitt Lymphoma (BL) | BL retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC). |
| BG003 | Historical Controls - Retinoblastoma (Rb) | Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC). |
| BG004 | mNavigator Users | Health care providers using mNavigator |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Prospective cohort of patients diagnosed with Rb where allied health providers used mNavigator to guide diagnosis and treatment at Bugando Medical Centre (BMC). 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 (DLBCL) or retinoblastoma. |
| OG002 | Historical Controls - Burkitt Lymphoma (BL) | BL retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC). |
| OG003 | Historical Controls - Retinoblastoma (Rb) | Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC). |
| OG004 | mNavigator Users | Health care providers using mNavigator |
|
|
|
| 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. | Participants who completed the study and historical controls. Does not apply to mNavigator Users. | Posted | Median | Standard Deviation | days | 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. | Participants who completed the study and historical controls. Does not apply to mNavigator Users. | Posted | Count of Participants | Participants | 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). | Participants who completed the study and historical controls. Does not apply to mNavigator Users. | Posted | Count of Participants | Participants | Approximately 1 year after treatment initiation |
|
|
|
| Other Pre-specified | 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. | Not Posted | Approximately 1 year | Participants |
| Other Pre-specified | Monthly Utilization of mNavigator | Number of forms submitted using mNavigator, stratified, by users, per month of implementation. | Not Posted | Approximately 1 year | Participants |
| Other Pre-specified | Number of Instances of mNavigator Failure Per Month (All-causes) | Only applies to mNavigator Users. | Posted | Mean | Standard Deviation | failures per month | Approximately 1 year |
|
|
|
| Other Pre-specified | Number of Instances of CommCare Failure Per Month (All-causes) | Number of instances of CommCare failure per month (all-causes) | Not Posted | Approximately 1 year | Participants |
| Other Pre-specified | Number of Instances of Device Failure Per Month (All-causes) | Number of instances of device failure per month (all-causes) | Not Posted | Approximately 1 year | Participants |
| Other Pre-specified | 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 | Not Posted | Approximately 1 year | Participants |
| Other Pre-specified | 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 | Not Posted | Approximately 1 year | Participants |
| Other Pre-specified | Average Time in Minutes Spent Completing Each Form, Stratified by Form | Average time in minutes spent completing each form, stratified by form | Not Posted | Approximately 1 year | Participants |
| Other Pre-specified | 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. | Not Posted | Approximately 1 year | Participants |
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | mNavigator - Retinoblastoma (Rb) | Prospective cohort of patients diagnosed with Rb where allied health providers used mNavigator to guide diagnosis and treatment at Bugando Medical Centre (BMC). 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 (DLBCL) or retinoblastoma. | 0 | 29 | 0 | 29 | 0 | 29 |
| EG002 | Historical Controls - Burkitt Lymphoma (BL) | BL retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Historical Controls - Retinoblastoma (Rb) | Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | mNavigator Users | Health care providers using mNavigator | 0 | 0 | 0 | 0 | 0 | 0 |
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| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D019572 | Retinal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |