Covid19NCT04649320
Perception of the COVID-19 Pandemic in Patients With Haematological or Solid Neoplasias
An observational study of Covid19, run by Medical University Innsbruck at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- questionnaire
- How many people
- 300 participants
- Where
- 1 siteAustria
- Study dates
- 23 Nov 2020to 31 Dec 2020
- Phase
- Observational
- 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
Study population: adult cancer patients, with solid or hematologic malignancies, neither tested positive nor having COVID19 symptoms, with an age over 18 years
Who may be able to join
- Age > 18 years
- validated hematological or oncological disease
- informed consent
Who cannot join
- Age < 18 years
- Insufficient discernment
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Innsbruck
Innsbruck, Tyrol, 6020
Reinhard Stauder, M.D., +43 512 504 81387, reinhard.stauder@i-med.ac.at
About this study
Official title: 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
Read the 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.
- Conditions
- Covid19
- Being tested
- questionnaire
- Keywords
- SARS-CoV-2, COVID19 pandemic, cancer patients, distress, HRQOL
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
- 13-item questionnaire about cancer patient's distress and everyday life,
- EORTC-QLQ-C30
| Study group | Role | What they receive |
|---|---|---|
| cancer patients | adult cancer patients, with solid or hematologic malignancies, neither tested positive nor having COVID19 symptoms Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of the COVID-19 pandemic on cancer patient's daily life
evaluation via questionnaire
Measured: single time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start23 Nov 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reinhard Stauder, M.D., Principal investigator, Medical University of Innsbruck, Anichstraße 35, A-6020 Innsbruck, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649320
- Sponsor's protocol ID
- 1264/2020
- Status last verified
- Nov 2020
- First submitted
- 30 Nov 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Perception of the COVID-19 Pandemic in Patients With Haematological or Solid Neoplasias Using Patient-reported Outcome Measures (PROMs)
- ClinicalTrials.gov ID
- NCT04649320
- Acronym / sponsor ID
- 1264/2020
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, COVID19 pandemic, cancer patients, distress, HRQOL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 2 Dec 2020 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cancer patients | – | Other: questionnaireadult cancer patients, with solid or hematologic malignancies, neither tested positive nor having COVID19 symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult cancer patients, with solid or hematologic malignancies, neither tested positive nor having COVID19 symptoms, with an age over 18 years
Key inclusion criteria (3 listed)
- Age > 18 years
- validated hematological or oncological disease
- informed consent
Key exclusion criteria (2 listed)
- Age < 18 years
- Insufficient discernment
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 |
|---|---|---|
| questionnaire1. 13-item questionnaire about cancer patient's distress and everyday life, 2. EORTC-QLQ-C30 | Other | cancer patients |
Primary outcome
Influence of the COVID-19 pandemic on cancer patient's daily life
Time frame: single time
evaluation via questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Reinhard Stauder, M.D. principal investigator
Medical University of Innsbruck, Anichstraße 35, A-6020 Innsbruck, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Medical University Innsbruck at 1 site in Austria.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reinhard Stauder, M.D. (+43 512 504 81387, reinhard.stauder@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of the COVID-19 pandemic on cancer patient's daily life (time frame: single time). 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 2 Dec 2020.