Clinical trial · Interventional
An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Covid19 | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
| PROMs | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ePROMs assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- All patients were presented the digital PROMs platform during their chemotherapy
- interventionNames
- Other: ePROMs assessment
Primary outcomes (95)
- measure
- Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- timeFrame
- Baseline
- description
- Questionnaire to evaluate the presence and severity of therapy-related side effects
- measure
- Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- timeFrame
- Week 1 of chemotherapy
- description
- Questionnaire to evaluate the presence and severity of therapy-related side effects
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available