Trial Outcomes & Findings for Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment (NCT NCT03677128)
NCT ID: NCT03677128
Last Updated: 2023-05-09
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Approximately 1 year
Results posted on
2023-05-09
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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).
|
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).
|
mNavigator Users
Health care providers using mNavigator
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
29
|
63
|
25
|
4
|
|
Overall Study
COMPLETED
|
36
|
16
|
63
|
25
|
4
|
|
Overall Study
NOT COMPLETED
|
10
|
13
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment
Baseline characteristics by cohort
| Measure |
mNavigator - Burkitt Lymphoma (BL)
n=36 Participants
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.
|
mNavigator - Retinoblastoma (Rb)
n=16 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.
|
Historical Controls - Burkitt Lymphoma (BL)
n=63 Participants
BL retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC).
|
Historical Controls - Retinoblastoma (Rb)
n=25 Participants
Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC).
|
mNavigator Users
Health care providers using mNavigator
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
8.2 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
2.8 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
9.5 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
3.3 years
STANDARD_DEVIATION 1.6 • n=4 Participants
|
—
|
5.95 years
STANDARD_DEVIATION 3.39 • n=8 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
—
|
55 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
—
|
85 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
—
|
140 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
—
|
140 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Tanzania
|
36 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
—
|
140 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Approximately 1 yearPopulation: Participants who completed the study and historical controls. Does not apply to mNavigator Users.
Outcome measures
| Measure |
mNavigator - Burkitt Lymphoma (BL)
n=36 Participants
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.
|
mNavigator - Retinoblastoma (Rb)
n=16 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.
|
Historical Controls - Burkitt Lymphoma (BL)
n=63 Participants
BL retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC).
|
Historical Controls - Retinoblastoma (Rb)
n=25 Participants
Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC).
|
mNavigator Users
Health care providers using mNavigator
|
|---|---|---|---|---|---|
|
Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy
|
73.8 percentage of compliance
Standard Deviation 15.1
|
96.0 percentage of compliance
Standard Deviation 5.1
|
50.0 percentage of compliance
Standard Deviation 16.0
|
74.9 percentage of compliance
Standard Deviation 11.9
|
—
|
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: Participants who completed the study and historical controls. Does not apply to mNavigator Users.
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.
Outcome measures
| Measure |
mNavigator - Burkitt Lymphoma (BL)
n=36 Participants
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.
|
mNavigator - Retinoblastoma (Rb)
n=16 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.
|
Historical Controls - Burkitt Lymphoma (BL)
n=63 Participants
BL retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC).
|
Historical Controls - Retinoblastoma (Rb)
n=25 Participants
Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC).
|
mNavigator Users
Health care providers using mNavigator
|
|---|---|---|---|---|---|
|
Time to Diagnosis (in Days)
|
0 days
Standard Deviation 3.3
|
0 days
Standard Deviation 0.5
|
5 days
Standard Deviation 145.9
|
0 days
Standard Deviation 1.0
|
—
|
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: Participants who completed the study and historical controls. Does not apply to mNavigator Users.
Treatment abandonment is defined as missing 4 or more consecutive weeks of treatment or follow-up while on therapy.
Outcome measures
| Measure |
mNavigator - Burkitt Lymphoma (BL)
n=36 Participants
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.
|
mNavigator - Retinoblastoma (Rb)
n=16 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.
|
Historical Controls - Burkitt Lymphoma (BL)
n=63 Participants
BL retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC).
|
Historical Controls - Retinoblastoma (Rb)
n=25 Participants
Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC).
|
mNavigator Users
Health care providers using mNavigator
|
|---|---|---|---|---|---|
|
Number of Participants Who Abandon Treatment
|
9 Participants
|
5 Participants
|
25 Participants
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: Approximately 1 year after treatment initiationPopulation: Participants who completed the study and historical controls. Does not apply to mNavigator Users.
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).
Outcome measures
| Measure |
mNavigator - Burkitt Lymphoma (BL)
n=36 Participants
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.
|
mNavigator - Retinoblastoma (Rb)
n=16 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.
|
Historical Controls - Burkitt Lymphoma (BL)
n=63 Participants
BL retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC).
|
Historical Controls - Retinoblastoma (Rb)
n=25 Participants
Rb retrospective patients (treated between 2015-2019) when standardized treatment protocols for BL (DLBCL) and Rb were introduced at Bugando Medical Centre (BMC).
|
mNavigator Users
Health care providers using mNavigator
|
|---|---|---|---|---|---|
|
Number of Participants Who Completed Treatment as Indicated
|
23 Participants
|
10 Participants
|
25 Participants
|
3 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 1 yearSystem 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 1 yearNumber of forms submitted using mNavigator, stratified, by users, per month of implementation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 1 yearPopulation: Only applies to mNavigator Users.
Outcome measures
| Measure |
mNavigator - Burkitt Lymphoma (BL)
n=4 Participants
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.
|
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.
|
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).
|
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).
|
mNavigator Users
Health care providers using mNavigator
|
|---|---|---|---|---|---|
|
Number of Instances of mNavigator Failure Per Month (All-causes)
|
0 failures per month
Standard Deviation 0
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 1 yearNumber of instances of CommCare failure per month (all-causes)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 1 yearNumber of instances of device failure per month (all-causes)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 1 yearNumber of hours of initial training as well as hours of ongoing support provided during the first month of implementation
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 1 yearNumber of users who are proficient in use of mNavigator within first month of implementation
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 1 yearAverage time in minutes spent completing each form, stratified by form
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 1 yearTotal 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.
Outcome measures
Outcome data not reported
Adverse Events
mNavigator - Burkitt Lymphoma (BL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
mNavigator - Retinoblastoma (Rb)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Historical Controls - Burkitt Lymphoma (BL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Historical Controls - Retinoblastoma (Rb)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
mNavigator Users
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place