An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic

NCT ID: NCT04816656

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2021-03-22

Brief Summary

During the COVID-19 pandemic, patients with cancer are subject to multiple risks (e.g. frequent hospital visits, increased infection risk, more severe clinical course, discontinued cancer treatment etc.).

Patients undergoing cancer therapy are also faced with several Quality of Life - impairing side effects. In the case of a positive COVID-19 cancer patient, the need and intensity of treating must be weighed against the possible higher risk of developing severe complications in the course of a COVID-19 infection. Nevertheless, both for COVID-19 positive and negative patients who will continue or discontinue cancer treatment throughout the pandemic, providing supportive care is more important than ever.

Digitally monitoring patient-reported outcome measures (PROMs) could offer a solution to improve the supportive care measures during cancer treatment, and certainly in times of COVID-19. Digitalized PROMS could significantly contribute to improved communication, patient satisfaction, supportive care, monitoring of cancer treatment, and detection of problems.

To date, clinical trials investigating the benefits of digital PROMS in patients with cancer during the current COVID-19 pandemic are lacking.

At the Jessa Hospital, the investigators already have experience in collecting PROMs via a digital platform (Awell Health) since 2019 for patients with breast cancer undergoing chemotherapy using validated QoL questionnaires.

The overall aim of this project is to prospectively evaluate the impact of a COVID-19 infection on the severity of the cancer therapy-related complications and the QoL of patients with cancer undergoing chemotherapy using a digital PROMs-platform.

Detailed Description

General aim: The overall aim of this project is to prospectively evaluate the impact of a COVID-19 infection on the severity of the cancer therapy-related complications and the QoL of patients with cancer undergoing chemotherapy using a digital PROMs platform.

Objective 1: Evaluate the effect of a COVID-19 infection on the severity of cancer therapy-related side effects and patients' QoL

Rationale: The functionality of this platform will be based on three main principles:

1. The digital PROMs platform will provide patient-tailored information throughout the course of their disease and up to one month after the end of their chemotherapy concerning complications and COVID-19. This will support the cancer patients during their disease with specific advice based on the side effects they document. First, this will help comfort patients and reduce their anxiety and insecurity in these stressful times. Second, they will receive information regarding measures they can take to tackle their specific complications. Third, this will encourage patients to seek help in case of a possible COVID-19 infection and/or severe side effects by contacting the oncological support team or their physician.

2. The platform will prospectively collect QoL data using validated patient-reported questionnaires and specific COVID-19 questionnaires via a mobile application.

3. The platform will be fully integrated into the electronic health record (EHR) of the patient and will provide a structured report of the questioned complications for the physician. This will allow the medical oncologist to monitor the medical journey of the patient during and up to one month after their chemotherapy. As such, the medical oncologist can finetune the cancer treatment and supportive care measures towards the needs of the patient.

Hypothesis: "An COVID-19 infection will aggravate the severity of the cancer therapy-related complications and thereby diminish the patients' QoL."

Objective 2: Evaluate the patient benefit of digital PROMS platform Rationale: The implementation of a digital PROMs platform for cancer patients has demonstrated multiple benefits in the past, ranging from enhanced patient satisfaction, detection of unrecognized problems, earlier detection of complications, and/or more specific supportive care measures leading to an improved treatment outcome and QoL.

Hypothesis: "The use of a digital PROMs platform for cancer patients undergoing chemotherapy during the COVID-19 pandemic will lead to (1) an improved patient satisfaction and general knowledge on the oncologic supportive care measures and (2) a reduction in patient distress and anxiety".

General approach (for both objectives): A prospective, cohort study will be set up in patients with cancer undergoing chemotherapy. Patients will be stratified during treatment in two groups: (1) COVID-19 positive and (2) negative patients. Patients will be instructed to fill in validated Qol, distress/anxiety, and COVID-19 specific questionnaires via a digital platform from the day of inclusion up to 1-month post-chemotherapy.

Conditions

Covid19; Oncology; PROMs; Chemotherapeutic Toxicity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental arm

All patients were presented the digital PROMs platform during their chemotherapy

Group Type: EXPERIMENTAL

ePROMs assessment

Intervention Type: OTHER

At inclusion the patient received a unique login code which he/she used to start the care path. After signing the informed consent on the digital pathway, the patient needed to fill in the questionnaires that were presented at fixed time points throughout this study.

Based on the data collected from the questionnaires the patient received customized information and advice. In case of COVID-19, the information and advice was based on the guidelines from Sciensano and the Belgian government. If the patient suffered from side effects from the cancer therapy, they received tips and tricks how to manage these complications. The collected data was forwarded to the patient medical file. As such health care workers were be able to use this information in the patients' follow up consultations.

Interventions

ePROMs assessment

At inclusion the patient received a unique login code which he/she used to start the care path. After signing the informed consent on the digital pathway, the patient needed to fill in the questionnaires that were presented at fixed time points throughout this study.

Based on the data collected from the questionnaires the patient received customized information and advice. In case of COVID-19, the information and advice was based on the guidelines from Sciensano and the Belgian government. If the patient suffered from side effects from the cancer therapy, they received tips and tricks how to manage these complications. The collected data was forwarded to the patient medical file. As such health care workers were be able to use this information in the patients' follow up consultations.

Intervention Type: OTHER

Other Intervention Names

Digital PROMs platform

Eligibility Criteria

Inclusion Criteria

• Diagnosed with any type of cancer (except breast cancer)
• Undergoing or starting chemotherapy with or without surgery
• Age ≥ 18 years
• Access to the online application via computer or smartphone
• Able to comply with the study protocol
• Able to sign written informed consent in the digital AWELL platform
• Provide a signed informed consent

Exclusion Criteria

• Diagnosed with breast cancer and undergoing chemotherapy (patients are already included in the healthcare path breast at Jessa Hospital)
• Undergoing other therapies (e.g. immunotherapy, radiotherapy, targeted therapy, hormonal therapy)
• Insufficient understanding of the Dutch language
• Severe cognitive impairment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hasselt University

OTHER

Sponsor Role: collaborator

Jessa Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeroen Mebis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital

Locations

Hasselt University

Hasselt, Limburg, Belgium

Jessa Ziekenhuis

Hasselt, Limburg, Belgium

Countries

Belgium

Other Identifiers

20.60-onco20.07

Identifier Type: -

Identifier Source: org_study_id