Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Eye Diseases

Infections

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Retinoblastoma

Lymphoma, B-Cell

Burkitt Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Retinal Neoplasms

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Neuroepithelioma

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.

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.

mNavigator

Kristin Schroeder, MD MPH

Lavanya Vasudevan, PhD

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.

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.

Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment

A Mobile Health (mHealth) Case Management System for Reducing Pediatric Cancer Treatment Abandonment

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.

Number of forms submitted using mNavigator, stratified, by users, per month of implementation.

Number of instances of CommCare failure per month (all-causes)

Number of instances of device failure per month (all-causes)

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

Number of users who are proficient in use of mNavigator within first month of implementation

Average time in minutes spent completing each form, stratified by form

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.

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.

Treatment abandonment is defined as missing 4 or more consecutive weeks of treatment or follow-up while on therapy.

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).

National Cancer Institute (NCI)

Duke University

Adverse Event data not collected on historical controls or mNavigator users.

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 - Burkitt Lymphoma (BL)

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.

mNavigator - Retinoblastoma (Rb)

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 - Burkitt Lymphoma (BL)

Rb 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)

mNavigator Users

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Tanzania

Region of Enrollment

Participants who completed the study. Baseline Characteristics not collected on mNavigator Users.

Participants who completed the study and historical controls. Does not apply to mNavigator Users.

Protocol Compliance as Measured by Percent Compliance to Prescribed Chemotherapy

Time to Diagnosis (in Days)

Number of Participants Who Abandon Treatment

Number of Participants Who Completed Treatment as Indicated

System Usability Scale Score

Monthly Utilization of mNavigator

Number of Instances of mNavigator Failure Per Month (All-causes)

Number of Instances of CommCare Failure Per Month (All-causes)

Number of Instances of Device Failure Per Month (All-causes)

Number of Hours of Initial Training as Well as Hours of Ongoing Support Provided During the First Month of Implementation

Number of Users Who Are Proficient in Use of mNavigator Within First Month of Implementation

Average Time in Minutes Spent Completing Each Form, Stratified by Form

Time Per Patient

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Vaccines

All girls attending standard 6 in schools selected for class-based vaccine delivery

All girls born in 1998 attending schools selected for age-based delivery

Gardasil® HPV vaccine

Deborah :L Watson-Jones, MD, PhD

Richard J Hayes, DSC

John Changalucha, BSc

The aims of this study are:

1. To determine feasibility of a school-based human papillomavirus (HPV) vaccination programme in Tanzania.
2. To measure the uptake and acceptability of two different vaccination strategies in rural and urban schools.
3. To examine the characteristics of accepters/refusers of vaccination and to identify reasons for acceptance, refusal or non-completion.
4. To measure the cost of implementing a school-based HPV vaccination programme in Tanzania.

Vaccines against human papillomavirus infection, the primary cause of cervical cancer, are an attractive cervical cancer prevention strategy for resource poor settings which lack the infrastructure for establishing and maintaining complex screening programmes.Feasibility and costs of setting up and sustaining an HPV vaccination programme will depend on whether it can be added onto an existing health programme within schools, if one exists, or whether it has to be established as a separate health intervention. Other factors will also affect vaccine coverage. For example, uptake and overall effectiveness will be critically dependent on parental and community acceptability of a vaccine that prevents a sexually transmitted infection and how the vaccine is promoted and delivered by health-care providers will influence its uptake and acceptability.

This study will determine feasibility, uptake and acceptability of different delivery strategies of school-based HPV vaccination in Tanzania, examine factors related to acceptance or refusal of vaccination and measure the cost of implementing a school-based HPV vaccination programme in Tanzania.

Three doses of quadrivalent human papillomavirus (HPV) vaccine, (Gardasil®; Merck \& Co) given at 0, 2 and 6 months, will be provided to 5000 primary school girls at 134 randomly selected schools in Mwanza Region in Tanzania. Selected schools will be randomly assigned to one of two delivery strategies (age-based or class-based) and coverage and acceptability of these vaccine delivery strategies will be compared. Qualitative research will be conducted before, during and after vaccination to examine barriers to vaccination and reasons for failure to complete vaccination as well as general community perceptions. To determine factors associated with refusal a case control study will be conducted on a 1:1 sample of 350 vaccine refusers and 350 accepters. The costs of introducing and scaling up HPV vaccines in schools will be estimated using established costing methods.

Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls

Vaccine coverage will be estimated for each dose given and for those completing the full course of vaccination and compared by delivery strategy.

A case control study to determine factors associated with refusal will be conducted on a 1:1 sample of 350 vaccine refusers and 350 accepters.

Qualitative research will be conducted to examine barriers to vaccination and reasons for failure to complete vaccination.

Full financial and economic costs from the provider's perspective will be collected for the intervention. Total costs of a district vaccination programme and cost per urban school and rural school reached (if urban/rural differences are identified) and cost per fully-vaccinated girl will be estimated for the two alternative delivery strategies.

National Institute for Medical Research, Tanzania

Ocean Road Cancer Institute, Tanzania

Institut Català d' Oncologia, Spain

Medical Research Council Social & Public Health Sciences Unit, UK

International Union Against Cancer, Switzerland

London School of Hygiene and Tropical Medicine

The SMS intervention will consist of 15 text messages that will be sent to the intervention group over a period of 10 months. There will be two types of text messages: (1) educational text messages; and (2) SMS reminders for the follow-up appointment.

The control group will receive standard care, which is a follow-up appointment at 14 months written on an appointment card.

10 health educative SMSs' sent once a month 5 SMS-reminders for follow-up appointment sent on days -14, -7, -1 pre- follow-up appointment, and +1, +7 post follow-up appointment

Connected to Care

Vibeke Rasch, MD

Julius Mwaiselage, MD

This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments.

Connected2Care is a non-blinded, multicentre, parallel-group, randomised controlled trial. Tanzanian Women testing positive to HR HPV at inclusion are randomly assigned in an allocation ratio of 1:1 to the SMS intervention or the control group (standard care). In a period of 10 months, the intervention group will receive 15 one-directional health educative text messages and SMS-reminders for their appointment. The total sample size will be 700 with 350 women in each study arm. Primary outcome is attendance rate for follow-up. Secondary objectives are cost-effectiveness measured through incremental ratios and knowledge of cervical cancer by a 16-item true/false scale questionnaire at baseline and follow-up.

Use of SMSs to Improve Attendance to Cervical Cancer Follow-up Screening

Text Messages to Increase Attendance to Follow-up Cervical Cancer Screening Appointments Among HPV Positive Tanzanian Women (Connected2Care)

The effect measure of the intervention is the 14-month follow-up attendance rate for HPV positive women. The number of women in the intervention group that attend follow-up screening will be compared to the the number of women that attend follow-up screening in the control group.

6-point Likert scale (1: I do not like it at all - 6: I like it very much)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment	NCT03677128	Burkitt Lymphom... Retinoblastoma Diffuse Large B...	mNavigator	-	Duke University
Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls	NCT01173900	Cervical Cancer	Gardasil® HPV v...	9 Years -	London School of Hygiene and Tropical Medicine
Use of SMSs to Improve Attendance to Cervical Cancer Follow-up Screening	NCT02509702	Cervical Cancer	Connected to Ca...	25 Years - 60 Years	Odense University Hospital

Spots Global Cancer Trial Database for tanzania

Every month we try and update this database with for tanzania cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tanzania

Every month we try and update this database with for tanzania cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tanzania cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.