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NCT Number: NCT04816656

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

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.

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Key information

Conditions

Covid19 COVID-19 Chemotherapeutic Toxicity Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Neoplasms Nidovirales Infections Oncology PROMs Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University, Hasselt, Limburg, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Digital PROMs platform

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 5-level EQ-5D version (EQ5D5L)

    Time frame: Baseline

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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. Covid-19 triage questionnaire

    Time frame: Baseline

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

  39. Covid-19 triage questionnaire

    Time frame: Week 1 of chemotherapy

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

  40. Covid-19 triage questionnaire

    Time frame: Week 2 of chemotherapy

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

  41. Covid-19 triage questionnaire

    Time frame: Week 3 of chemotherapy

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

  42. Covid-19 triage questionnaire

    Time frame: Week 4 of chemotherapy

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

  43. Covid-19 triage questionnaire

    Time frame: Week 5 of chemotherapy

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

  44. Covid-19 triage questionnaire

    Time frame: Week 6 of chemotherapy

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

  45. Covid-19 triage questionnaire

    Time frame: Week 7 of chemotherapy

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

  46. Covid-19 triage questionnaire

    Time frame: Week 8 of chemotherapy

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

  47. Covid-19 triage questionnaire

    Time frame: Week 9 of chemotherapy

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

  48. Covid-19 triage questionnaire

    Time frame: Week 10 of chemotherapy

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

  49. Covid-19 triage questionnaire

    Time frame: Week 11 of chemotherapy

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

  50. Covid-19 triage questionnaire

    Time frame: Week 12 of chemotherapy

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

  51. Covid-19 triage questionnaire

    Time frame: Week 13 of chemotherapy

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

  52. Covid-19 triage questionnaire

    Time frame: Week 14 of chemotherapy

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

  53. Covid-19 triage questionnaire

    Time frame: Week 15 of chemotherapy

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

  54. Covid-19 triage questionnaire

    Time frame: Week 16 of chemotherapy

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

  55. Covid-19 triage questionnaire

    Time frame: Week 17 of chemotherapy

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

  56. Covid-19 triage questionnaire

    Time frame: Week 18 of chemotherapy

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

  57. Covid-19 triage questionnaire

    Time frame: Week 19 of chemotherapy

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

  58. Covid-19 triage questionnaire

    Time frame: Week 20 of chemotherapy

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

  59. Covid-19 triage questionnaire

    Time frame: Week 21 of chemotherapy

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

  60. Covid-19 triage questionnaire

    Time frame: Week 22 of chemotherapy

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

  61. Covid-19 triage questionnaire

    Time frame: Week 23 of chemotherapy

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

  62. Covid-19 triage questionnaire

    Time frame: Week 24 of chemotherapy

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

  63. Covid-19 triage questionnaire

    Time frame: 1 week post-chemotherapy

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

  64. Covid-19 triage questionnaire

    Time frame: 2 weeks post-chemotherapy

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

  65. Covid-19 triage questionnaire

    Time frame: 3 weeks post-chemotherapy

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

  66. Covid-19 triage questionnaire

    Time frame: 1 month post-chemotherapy

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

  67. COVID-19 questionnaire

    Time frame: First day of positive COVID-19 test

    Questionnaire about symptom burden related to COVID-19

  68. COVID-19 questionnaire

    Time frame: Second day after positive COVID-19 test

    Questionnaire about symptom burden related to COVID-19

  69. COVID-19 questionnaire

    Time frame: Third day after positive COVID-19 test

    Questionnaire about symptom burden related to COVID-19

  70. COVID-19 questionnaire

    Time frame: Fourth day after positive COVID-19 test

    Questionnaire about symptom burden related to COVID-19

  71. COVID-19 questionnaire

    Time frame: Fifth day after positive COVID-19 test

    Questionnaire about symptom burden related to COVID-19

  72. COVID-19 questionnaire

    Time frame: Sixth day after positive COVID-19 test

    Questionnaire about symptom burden related to COVID-19

  73. COVID-19 questionnaire

    Time frame: Seventh day after positive COVID-19 test

    Questionnaire about symptom burden related to COVID-19

  74. COVID-19 questionnaire

    Time frame: Eight day after positive COVID-19 test

    Questionnaire about symptom burden related to COVID-19

  75. COVID-19 questionnaire

    Time frame: Ninth day after positive COVID-19 test

    Questionnaire about symptom burden related to COVID-19

  76. COVID-19 questionnaire

    Time frame: Tenth day after positive COVID-19 test

    Questionnaire about symptom burden related to COVID-19

  77. COVID-19 questionnaire

    Time frame: Eleventh day after positive COVID-19 test

    Questionnaire about symptom burden related to COVID-19

  78. COVID-19 questionnaire

    Time frame: Twelfth day after positive COVID-19 test

    Questionnaire about symptom burden related to COVID-19

  79. COVID-19 questionnaire

    Time frame: Thirteenth day after positive COVID-19 test

    Questionnaire about symptom burden related to COVID-19

  80. COVID-19 questionnaire

    Time frame: Fourteenth day after positive COVID-19 test

    Questionnaire about symptom burden related to COVID-19

  81. 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

  82. 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

  83. 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

  84. 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

  85. 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

  86. 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

  87. 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

  88. 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

  89. 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

  90. 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

  91. 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

  92. 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

  93. 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

  94. 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

  95. 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

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Collaborators

  • Hasselt University

Registry information

Acronym: COVID-ONCO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2021
Registry last updated
Mar 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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