Neoplasms

All Conditions

Symptoms and General Pathology

Adenocarcinoma

Body Weight

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Elderly patients diagnosed with resectable PDAC underwent radical surgery.

Elderly patients diagnosed with resectable PDAC abandoned radical surgery, the reasons of treatment abandonment included surgeons didn't recommend surgery for their elderly patients and patients chose to refuse surgery.

Researchers want to investigate some important factors that influence elderly patients not to undergo radical surgery.

potential predictors

More and more older adults are diagnosed with pancreatic ductal adenocarcinoma (PDAC), but the rate of surgical resection in patients with resectable tumour is still low. Clinical workers need to take more attention to oncologic care in this group. It's significant to explore potential predictors for impacting elderly patients chose to abandon surgical resection.

The incidence of pancreatic ductal adenocarcinoma (PDAC) in the elderly has been on the rise, but the elderly were always neglected in clinical oncology care. Pancreatic ductal adenocarcinoma is a lethal disease, and the most effective treatment for curing it remains the radical resection. Unfortunately, there are many a study had reported that the rate of radical surgery of patients with PDAC has been low in the past decade. In order for more elderly pancreatic cancer patients to undergo surgical resection, investigators extracted the data of elderly patients with PDAC from SEER program and investigated predictive factors associated with surgical resection abandonment. In this study, investigators extracted data of patients older than 75 years diagnosed with T1-T3 stage PDAC to investigate rate of radical surgery. And researchers used Univariate and multivariate logistic regression model to explore potential factors associated with patients and surgeon chose to abandon surgical resection.

Predictors for Low Rates of Surgical Resection in Elderly Patients With Resectable Pancreatic Ductal Adenocarcinoma

Department of Hepato-Biliary-Pancreatic Surgery, Huadong Hospital Affliated to Fudan University

Univariate and multivariate logistic regression model were used to calculate ORs

The date of definite diagnosis to death or last follow up

Fudan University

Director of hospital

Blood and Lymph Conditions

Immune System Diseases

Eye Diseases

Infections

Diseases and Abnormalities at or Before Birth

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Retinoblastoma

Lymphoma, B-Cell

Burkitt Lymphoma

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, 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Predictors for Low Rates of Surgical Resection in Elderly Patients With Resectable Pancreatic Ductal Adenocarcinoma	NCT06344299	Pancreatic Duct...	potential predi...	75 Years - 100 Years	Fudan University
Mobile Health Case Management System for Reducing Pediatric Treatment Abandonment	NCT03677128	Burkitt Lymphom... Retinoblastoma Diffuse Large B...	mNavigator	-	Duke University
Predictors for Low Rates of Surgical Resection in Elderly Patients With Resectable Pancreatic Ductal Adenocarcinoma	NCT06344299	Pancreatic Duct...	potential predi...	75 Years - 100 Years	Fudan University

Spots Global Cancer Trial Database for treatment abandonment