Perception of the COVID-19 Pandemic in Patients With Haematological or Solid Neoplasias

Investigation of the Perception of the COVID-19 Pandemic in Patients With Haematological or Solid Neoplasias Using Patient-reported Outcome Measures (PROMs)

Cancer patients are among the most vulnerable individuals, whose health-related quality of life (HRQOL) may be substantially impacted by the COVID19 pandemic. We want to study how the COVID-19 pandemic influences the life of cancer patients and how these patients cope with the additional distress with the aim to facilitate the development of improved future interventional strategies to maintain resilience and HRQOL

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Other: questionnaire

Detailed Description

In December 2019, the novel human pathogenic virus "SARS-CoV2" from the coronavirus family was identified, causing a respiratory disease known as "COVID19" (coronavirus disease 2019). COVID19 manifests itself primarily with influenza-like symptoms, but in special cases it can lead to severe conditions such as ARDS (acute respiratory distress syndrome). Compared to other pulmotropic viruses such as the influenza virus, SARS-CoV-2 is associated with a higher contagiousness and mortality.

Haematological and oncological patients are particularly vulnerable due to their advanced age, immunological restrictions in the context of the underlying disease and the treatment modalities (chemotherapy, radiation therapy, ...).

To evaluate the effects of the COVID19 pandemic on the perception of patients with malignant diseases, we aim to record so-called "patient-reported outcomes" (PROs) from patients at the University Hospital of Innsbruck at the Department of Internal Medicine V (Hematology and Oncology) and at the Department for Radiotherapy and Radiation Oncology. We use the validated EORT QLQ-C30 and a specially developed questionnaire for COVID19.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Recruiting
      • Medical University of Innsbruck
      • Contact: Reinhard Stauder, M.D.; Phone Number: +43 512 504 81387; Email: reinhard.stauder@i-med.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult cancer patients, with solid or hematologic malignancies, neither tested positive nor having COVID19 symptoms, with an age over 18 years

Description

Inclusion Criteria:

• Age > 18 years
• validated hematological or oncological disease
• informed consent

Exclusion Criteria:

• Age < 18 years
• Insufficient discernment

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cancer patients; adult cancer patients, with solid or hematologic malignancies, neither tested positive nor having COVID19 symptoms	Other: questionnaire; 13-item questionnaire about cancer patient's distress and everyday life,; EORTC-QLQ-C30

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of the COVID-19 pandemic on cancer patient's daily life	evaluation via questionnaire	single time

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Reinhard Stauder, M.D., Medical University of Innsbruck, Anichstraße 35, A-6020 Innsbruck, Austria

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; HRQOL; distress; cancer patients; COVID19 pandemic
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 1264/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No