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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04649320
• Other study ID #: 1264/2020
• Status: Recruiting
• Start date: November 23, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2020
• Source: Medical University Innsbruck
• Contact: Reinhard Stauder, M.D.
• Phone: +43 512 504 81387
• Email: reinhard.stauder[@]i-med.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• validated hematological or oncological disease

• informed consent

Exclusion Criteria:

• Age < 18 years

• Insufficient discernment

Related Conditions & MeSH terms

• Covid19
• Neoplasms

Intervention

Other:
• questionnaire
13-item questionnaire about cancer patient's distress and everyday life, EORTC-QLQ-C30

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of the COVID-19 pandemic on cancer patient's daily life	evaluation via questionnaire	single time