Covid19COVID-ONCONCT04816656
An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic
A study testing ePROMs assessment in people with Covid19 and Oncology, run by Jessa Hospital at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- ePROMs assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesBelgium
- Study dates
- 3 Aug 2020to 22 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Hasselt University
Hasselt, Limburg, 3500
Jessa Ziekenhuis
Hasselt, Limburg, 3500
About this study
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.
Read more
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.
Read the 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:
- 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.
- The platform will prospectively collect QoL data using validated patient-reported questionnaires and specific COVID-19 questionnaires via a mobile application.
- 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
- Being tested
- ePROMs assessment
- Keywords
- Digital Health, Telemonitoring, Supportive Cancer Care, Oncology, PROMs, COVID-19
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePROMs assessmentOther
Also called Digital PROMs platform
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | All patients were presented the digital PROMs platform during their chemotherapy Receives: Other: ePROMs assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Questionnaire to evaluate the presence and severity of therapy-related side effects
Measured: Baseline
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Questionnaire to evaluate the presence and severity of therapy-related side effects
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 month post-chemotherapy
5-level EQ-5D version (EQ5D5L)
Questionnaire to evaluate patients' health-related quality of life on five different levels
Measured: Baseline
5-level EQ-5D version (EQ5D5L)
Questionnaire to evaluate patients' health-related quality of life on five different levels
Measured: Month 1 of chemotherapy
5-level EQ-5D version (EQ5D5L)
Questionnaire to evaluate patients' health-related quality of life on five different levels
Measured: Month 2 of chemotherapy
5-level EQ-5D version (EQ5D5L)
Questionnaire to evaluate patients' health-related quality of life on five different levels
Measured: Month 3 of chemotherapy
5-level EQ-5D version (EQ5D5L)
Questionnaire to evaluate patients' health-related quality of life on five different levels
Measured: Month 4 of chemotherapy
5-level EQ-5D version (EQ5D5L)
Questionnaire to evaluate patients' health-related quality of life on five different levels
Measured: Month 5 of chemotherapy
5-level EQ-5D version (EQ5D5L)
Questionnaire to evaluate patients' health-related quality of life on five different levels
Measured: Month 6 of chemotherapy
5-level EQ-5D version (EQ5D5L)
Questionnaire to evaluate patients' health-related quality of life on five different levels
Measured: 1 month post-chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Baseline
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 1 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 2 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 3 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 4 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 5 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 6 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 7 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 8 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 9 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 10 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 11 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 12 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 13 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 14 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 15 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 16 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 17 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 18 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 19 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 20 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 21 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 22 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 23 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: Week 24 of chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: 1 week post-chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: 2 weeks post-chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: 3 weeks post-chemotherapy
Covid-19 triage questionnaire
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Measured: 1 month post-chemotherapy
COVID-19 questionnaire
Questionnaire about symptom burden related to COVID-19
Measured: First day of positive COVID-19 test
COVID-19 questionnaire
Questionnaire about symptom burden related to COVID-19
Measured: Second day after positive COVID-19 test
COVID-19 questionnaire
Questionnaire about symptom burden related to COVID-19
Measured: Third day after positive COVID-19 test
COVID-19 questionnaire
Questionnaire about symptom burden related to COVID-19
Measured: Fourth day after positive COVID-19 test
COVID-19 questionnaire
Questionnaire about symptom burden related to COVID-19
Measured: Fifth day after positive COVID-19 test
COVID-19 questionnaire
Questionnaire about symptom burden related to COVID-19
Measured: Sixth day after positive COVID-19 test
COVID-19 questionnaire
Questionnaire about symptom burden related to COVID-19
Measured: Seventh day after positive COVID-19 test
COVID-19 questionnaire
Questionnaire about symptom burden related to COVID-19
Measured: Eight day after positive COVID-19 test
COVID-19 questionnaire
Questionnaire about symptom burden related to COVID-19
Measured: Ninth day after positive COVID-19 test
COVID-19 questionnaire
Questionnaire about symptom burden related to COVID-19
Measured: Tenth day after positive COVID-19 test
COVID-19 questionnaire
Questionnaire about symptom burden related to COVID-19
Measured: Eleventh day after positive COVID-19 test
COVID-19 questionnaire
Questionnaire about symptom burden related to COVID-19
Measured: Twelfth day after positive COVID-19 test
COVID-19 questionnaire
Questionnaire about symptom burden related to COVID-19
Measured: Thirteenth day after positive COVID-19 test
COVID-19 questionnaire
Questionnaire about symptom burden related to COVID-19
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 month post-chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start3 Aug 2020
- Primary completion1 Feb 2021
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, cohort study
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hasselt University
- Responsible party
- Sponsor
- Investigators
- Jeroen Mebis, MD, PhD, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816656
- Sponsor's protocol ID
- 20.60-onco20.07
- Acronym
- COVID-ONCO
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04816656
- Acronym / sponsor ID
- COVID-ONCO / 20.60-onco20.07
- Conditions
- Covid19, Oncology, PROMs, Chemotherapeutic Toxicity
- Keywords
- Digital Health, Telemonitoring, Supportive Cancer Care, Oncology, PROMs, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Collaborators
- Hasselt University
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- The platform will prospectively collect QoL data using validated patient-reported questionnaires and specific COVID-19 questionnaires via a mobile application.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, cohort study
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: ePROMs assessmentAll patients were presented the digital PROMs platform during their chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePROMs assessmentAlso: Digital PROMs platformAt 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. | Other | Experimental arm |
Primary outcome
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Baseline
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 1 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 2 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 3 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 4 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 5 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 6 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 7 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 8 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 9 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 10 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 11 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 12 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 13 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 14 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 15 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 16 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 17 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 18 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 19 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 20 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 21 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 22 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 23 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Week 24 of chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: 1 week post-chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: 2 weeks post-chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: 3 weeks post-chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: 1 month post-chemotherapy
Questionnaire to evaluate the presence and severity of therapy-related side effects
5-level EQ-5D version (EQ5D5L)
Time frame: Baseline
Questionnaire to evaluate patients' health-related quality of life on five different levels
5-level EQ-5D version (EQ5D5L)
Time frame: Month 1 of chemotherapy
Questionnaire to evaluate patients' health-related quality of life on five different levels
5-level EQ-5D version (EQ5D5L)
Time frame: Month 2 of chemotherapy
Questionnaire to evaluate patients' health-related quality of life on five different levels
5-level EQ-5D version (EQ5D5L)
Time frame: Month 3 of chemotherapy
Questionnaire to evaluate patients' health-related quality of life on five different levels
5-level EQ-5D version (EQ5D5L)
Time frame: Month 4 of chemotherapy
Questionnaire to evaluate patients' health-related quality of life on five different levels
5-level EQ-5D version (EQ5D5L)
Time frame: Month 5 of chemotherapy
Questionnaire to evaluate patients' health-related quality of life on five different levels
5-level EQ-5D version (EQ5D5L)
Time frame: Month 6 of chemotherapy
Questionnaire to evaluate patients' health-related quality of life on five different levels
5-level EQ-5D version (EQ5D5L)
Time frame: 1 month post-chemotherapy
Questionnaire to evaluate patients' health-related quality of life on five different levels
Covid-19 triage questionnaire
Time frame: Baseline
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 1 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 2 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 3 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 4 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 5 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 6 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 7 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 8 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 9 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 10 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 11 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 12 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 13 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 14 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 15 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 16 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 17 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 18 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 19 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 20 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 21 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 22 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 23 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: Week 24 of chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: 1 week post-chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: 2 weeks post-chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: 3 weeks post-chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
Covid-19 triage questionnaire
Time frame: 1 month post-chemotherapy
Questionnaire to screen patients for the possibility of a COVID-19 infection.
COVID-19 questionnaire
Time frame: First day of positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
COVID-19 questionnaire
Time frame: Second day after positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
COVID-19 questionnaire
Time frame: Third day after positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
COVID-19 questionnaire
Time frame: Fourth day after positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
COVID-19 questionnaire
Time frame: Fifth day after positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
COVID-19 questionnaire
Time frame: Sixth day after positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
COVID-19 questionnaire
Time frame: Seventh day after positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
COVID-19 questionnaire
Time frame: Eight day after positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
COVID-19 questionnaire
Time frame: Ninth day after positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
COVID-19 questionnaire
Time frame: Tenth day after positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
COVID-19 questionnaire
Time frame: Eleventh day after positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
COVID-19 questionnaire
Time frame: Twelfth day after positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
COVID-19 questionnaire
Time frame: Thirteenth day after positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
COVID-19 questionnaire
Time frame: Fourteenth day after positive COVID-19 test
Questionnaire about symptom burden related to COVID-19
COVID-19 Peritraumatic Distress Index (CPDI)
Time frame: Baseline
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
COVID-19 Peritraumatic Distress Index (CPDI)
Time frame: Month 1 of chemotherapy
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
COVID-19 Peritraumatic Distress Index (CPDI)
Time frame: Month 2 of chemotherapy
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
COVID-19 Peritraumatic Distress Index (CPDI)
Time frame: Month 3 of chemotherapy
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
COVID-19 Peritraumatic Distress Index (CPDI)
Time frame: Month 4 of chemotherapy
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
COVID-19 Peritraumatic Distress Index (CPDI)
Time frame: Month 5 of chemotherapy
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
COVID-19 Peritraumatic Distress Index (CPDI)
Time frame: Month 6 of chemotherapy
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
COVID-19 Peritraumatic Distress Index (CPDI)
Time frame: 1 month post-chemotherapy
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
Patient satisfaction
Time frame: Month 1 of chemotherapy
Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care
Patient satisfaction
Time frame: Month 2 of chemotherapy
Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care
Patient satisfaction
Time frame: Month 3 of chemotherapy
Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care
Patient satisfaction
Time frame: Month 4 of chemotherapy
Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care
Patient satisfaction
Time frame: Month 5 of chemotherapy
Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care
Patient satisfaction
Time frame: Month 6 of chemotherapy
Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care
Patient satisfaction
Time frame: 1 month post-chemotherapy
Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeroen Mebis, MD, PhD principal investigator
Jessa Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePROMs assessment in people with Covid19 and Oncology, run by Jessa Hospital at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) (time frame: Baseline). The study lists 95 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.