Clinical trial NCT04816656: An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic
Official title: An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Oncology
PROMs
Chemotherapeutic Toxicity
Keywords: Digital Health
Telemonitoring
Supportive Cancer Care
Oncology
PROMs
COVID-19
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
Collaborators: name: Hasselt University
First posted: 2021-03-25
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, cohort study
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Baseline
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 1 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 2 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 3 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 4 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 5 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 6 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 7 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 8 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 9 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 10 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 11 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 12 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 13 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 14 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 15 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 16 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 17 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 18 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 19 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 20 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 21 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 22 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 23 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Week 24 of chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: 1 week post-chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: 2 weeks post-chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: 3 weeks post-chemotherapy
measure: Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: 1 month post-chemotherapy
measure: 5-level EQ-5D version (EQ5D5L)
timeFrame: Baseline
measure: 5-level EQ-5D version (EQ5D5L)
timeFrame: Month 1 of chemotherapy
measure: 5-level EQ-5D version (EQ5D5L)
timeFrame: Month 2 of chemotherapy
measure: 5-level EQ-5D version (EQ5D5L)
timeFrame: Month 3 of chemotherapy
measure: 5-level EQ-5D version (EQ5D5L)
timeFrame: Month 4 of chemotherapy
measure: 5-level EQ-5D version (EQ5D5L)
timeFrame: Month 5 of chemotherapy
measure: 5-level EQ-5D version (EQ5D5L)
timeFrame: Month 6 of chemotherapy
measure: 5-level EQ-5D version (EQ5D5L)
timeFrame: 1 month post-chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Baseline
measure: Covid-19 triage questionnaire
timeFrame: Week 1 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 2 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 3 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 4 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 5 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 6 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 7 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 8 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 9 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 10 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 11 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 12 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 13 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 14 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 15 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 16 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 17 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 18 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 19 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 20 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 21 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 22 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 23 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: Week 24 of chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: 1 week post-chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: 2 weeks post-chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: 3 weeks post-chemotherapy
measure: Covid-19 triage questionnaire
timeFrame: 1 month post-chemotherapy
measure: COVID-19 questionnaire
timeFrame: First day of positive COVID-19 test
measure: COVID-19 questionnaire
timeFrame: Second day after positive COVID-19 test
measure: COVID-19 questionnaire
timeFrame: Third day after positive COVID-19 test
measure: COVID-19 questionnaire
timeFrame: Fourth day after positive COVID-19 test
measure: COVID-19 questionnaire
timeFrame: Fifth day after positive COVID-19 test
measure: COVID-19 questionnaire
timeFrame: Sixth day after positive COVID-19 test
measure: COVID-19 questionnaire
timeFrame: Seventh day after positive COVID-19 test
measure: COVID-19 questionnaire
timeFrame: Eight day after positive COVID-19 test
measure: COVID-19 questionnaire
timeFrame: Ninth day after positive COVID-19 test
measure: COVID-19 questionnaire
timeFrame: Tenth day after positive COVID-19 test
measure: COVID-19 questionnaire
timeFrame: Eleventh day after positive COVID-19 test
measure: COVID-19 questionnaire
timeFrame: Twelfth day after positive COVID-19 test
measure: COVID-19 questionnaire
timeFrame: Thirteenth day after positive COVID-19 test
measure: COVID-19 questionnaire
timeFrame: Fourteenth day after positive COVID-19 test
measure: COVID-19 Peritraumatic Distress Index (CPDI)
timeFrame: Baseline
measure: COVID-19 Peritraumatic Distress Index (CPDI)
timeFrame: Month 1 of chemotherapy
measure: COVID-19 Peritraumatic Distress Index (CPDI)
timeFrame: Month 2 of chemotherapy
measure: COVID-19 Peritraumatic Distress Index (CPDI)
timeFrame: Month 3 of chemotherapy
measure: COVID-19 Peritraumatic Distress Index (CPDI)
timeFrame: Month 4 of chemotherapy
measure: COVID-19 Peritraumatic Distress Index (CPDI)
timeFrame: Month 5 of chemotherapy
measure: COVID-19 Peritraumatic Distress Index (CPDI)
timeFrame: Month 6 of chemotherapy
measure: COVID-19 Peritraumatic Distress Index (CPDI)
timeFrame: 1 month post-chemotherapy
measure: Patient satisfaction
timeFrame: Month 1 of chemotherapy
measure: Patient satisfaction
timeFrame: Month 2 of chemotherapy
measure: Patient satisfaction
timeFrame: Month 3 of chemotherapy
measure: Patient satisfaction
timeFrame: Month 4 of chemotherapy
measure: Patient satisfaction
timeFrame: Month 5 of chemotherapy
measure: Patient satisfaction
timeFrame: Month 6 of chemotherapy
measure: Patient satisfaction
timeFrame: 1 month post-chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
state: Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Limburg
Study officials:
affiliation: Jessa Hospital
name: Jeroen Mebis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: