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

NCT04816656 | Completed

• 1 other identifier: 20.60-onco20.07
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19; Oncology; PROMs; Chemotherapeutic Toxicity

Keywords

Digital Health; Telemonitoring; Supportive Cancer Care; Oncology; PROMs; COVID-19

Outcome Measures

Primary Outcomes (95)

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Baseline

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 1 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 2 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 3 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 4 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 5 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 6 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 7 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 8 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 9 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 10 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 11 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 12 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 13 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 14 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 15 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 16 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 17 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 18 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 19 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 20 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 21 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 22 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 23 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  Week 24 of chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  1 week post-chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  2 weeks post-chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  3 weeks post-chemotherapy

• Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  Questionnaire to evaluate the presence and severity of therapy-related side effects

  1 month post-chemotherapy

• 5-level EQ-5D version (EQ5D5L)

  Questionnaire to evaluate patients' health-related quality of life on five different levels

  Baseline

• 5-level EQ-5D version (EQ5D5L)

  Questionnaire to evaluate patients' health-related quality of life on five different levels

  Month 1 of chemotherapy

• 5-level EQ-5D version (EQ5D5L)

  Questionnaire to evaluate patients' health-related quality of life on five different levels

  Month 2 of chemotherapy

• 5-level EQ-5D version (EQ5D5L)

  Questionnaire to evaluate patients' health-related quality of life on five different levels

  Month 3 of chemotherapy

• 5-level EQ-5D version (EQ5D5L)

  Questionnaire to evaluate patients' health-related quality of life on five different levels

  Month 4 of chemotherapy

• 5-level EQ-5D version (EQ5D5L)

  Questionnaire to evaluate patients' health-related quality of life on five different levels

  Month 5 of chemotherapy

• 5-level EQ-5D version (EQ5D5L)

  Questionnaire to evaluate patients' health-related quality of life on five different levels

  Month 6 of chemotherapy

• 5-level EQ-5D version (EQ5D5L)

  Questionnaire to evaluate patients' health-related quality of life on five different levels

  1 month post-chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Baseline

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 1 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 2 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 3 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 4 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 5 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 6 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 7 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 8 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 9 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 10 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 11 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 12 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 13 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 14 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 15 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 16 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 17 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 18 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 19 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 20 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 21 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 22 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 23 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  Week 24 of chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  1 week post-chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  2 weeks post-chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  3 weeks post-chemotherapy

• Covid-19 triage questionnaire

  Questionnaire to screen patients for the possibility of a COVID-19 infection.

  1 month post-chemotherapy

• COVID-19 questionnaire

  Questionnaire about symptom burden related to COVID-19

  First day of positive COVID-19 test

• COVID-19 questionnaire

  Questionnaire about symptom burden related to COVID-19

  Second day after positive COVID-19 test

• COVID-19 questionnaire

  Questionnaire about symptom burden related to COVID-19

  Third day after positive COVID-19 test

• COVID-19 questionnaire

  Questionnaire about symptom burden related to COVID-19

  Fourth day after positive COVID-19 test

• COVID-19 questionnaire

  Questionnaire about symptom burden related to COVID-19

  Fifth day after positive COVID-19 test

• COVID-19 questionnaire

  Questionnaire about symptom burden related to COVID-19

  Sixth day after positive COVID-19 test

• COVID-19 questionnaire

  Questionnaire about symptom burden related to COVID-19

  Seventh day after positive COVID-19 test

• COVID-19 questionnaire

  Questionnaire about symptom burden related to COVID-19

  Eight day after positive COVID-19 test

• COVID-19 questionnaire

  Questionnaire about symptom burden related to COVID-19

  Ninth day after positive COVID-19 test

• COVID-19 questionnaire

  Questionnaire about symptom burden related to COVID-19

  Tenth day after positive COVID-19 test

• COVID-19 questionnaire

  Questionnaire about symptom burden related to COVID-19

  Eleventh day after positive COVID-19 test

• COVID-19 questionnaire

  Questionnaire about symptom burden related to COVID-19

  Twelfth day after positive COVID-19 test

• COVID-19 questionnaire

  Questionnaire about symptom burden related to COVID-19

  Thirteenth day after positive COVID-19 test

• COVID-19 questionnaire

  Questionnaire about symptom burden related to COVID-19

  Fourteenth day after positive COVID-19 test

• COVID-19 Peritraumatic Distress Index (CPDI)

  Questionnaire to capture the frequency of specific phobias and stress disorders relevant to COVID-19, including anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behavior, physical symptoms and loss of social functioning

  Baseline

• COVID-19 Peritraumatic Distress Index (CPDI)

  Questionnaire to capture the frequency of specific phobias and stress disorders relevant to COVID-19, including anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behavior, physical symptoms and loss of social functioning

  Month 1 of chemotherapy

• COVID-19 Peritraumatic Distress Index (CPDI)

  Questionnaire to capture the frequency of specific phobias and stress disorders relevant to COVID-19, including anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behavior, physical symptoms and loss of social functioning

  Month 2 of chemotherapy

• COVID-19 Peritraumatic Distress Index (CPDI)

  Questionnaire to capture the frequency of specific phobias and stress disorders relevant to COVID-19, including anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behavior, physical symptoms and loss of social functioning

  Month 3 of chemotherapy

• COVID-19 Peritraumatic Distress Index (CPDI)

  Questionnaire to capture the frequency of specific phobias and stress disorders relevant to COVID-19, including anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behavior, physical symptoms and loss of social functioning

  Month 4 of chemotherapy

• COVID-19 Peritraumatic Distress Index (CPDI)

  Questionnaire to capture the frequency of specific phobias and stress disorders relevant to COVID-19, including anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behavior, physical symptoms and loss of social functioning

  Month 5 of chemotherapy

• COVID-19 Peritraumatic Distress Index (CPDI)

  Questionnaire to capture the frequency of specific phobias and stress disorders relevant to COVID-19, including anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behavior, physical symptoms and loss of social functioning

  Month 6 of chemotherapy

• COVID-19 Peritraumatic Distress Index (CPDI)

  Questionnaire to capture the frequency of specific phobias and stress disorders relevant to COVID-19, including anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behavior, physical symptoms and loss of social functioning

  1 month post-chemotherapy

• Patient satisfaction

  Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care

  Month 1 of chemotherapy

• Patient satisfaction

  Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care

  Month 2 of chemotherapy

• Patient satisfaction

  Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care

  Month 3 of chemotherapy

• Patient satisfaction

  Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care

  Month 4 of chemotherapy

• Patient satisfaction

  Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care

  Month 5 of chemotherapy

• Patient satisfaction

  Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care

  Month 6 of chemotherapy

• Patient satisfaction

  Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care

  1 month post-chemotherapy

Study Arms (1)

Experimental arm

EXPERIMENTAL

All patients were presented the digital PROMs platform during their chemotherapy

Other: ePROMs assessment

Interventions

ePROMs assessment 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.

Also known as: Digital PROMs platform

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessa Hospital: lead
• Hasselt University: collaborator

Study Sites (2)

Hasselt University

Hasselt, Limburg, 3500, Belgium

Location

Jessa Ziekenhuis

Hasselt, Limburg, 3500, Belgium

Location

MeSH Terms

Conditions

COVID-19; Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jeroen Mebis, MD, PhD

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, cohort study

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 25, 2021
• Study Start: August 3, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 22, 2021
• Last Updated: March 26, 2021

Record last verified: 2021-03

Locations

BE (2)