NCT04389996

Brief Summary

The outbreak of coronavirus was categorized as a global pandemic in March 2020. The Danish government recommends social distancing during the COVID-19 pandemic. Long-term social distancing and fear of disease can lead to anxiety, depression and the feeling of loneliness. All these factors might affect the quality of life (QoL). The aim of this study is to investigate the overall QoL for patients with cancer during the COVID-19 pandemic with special focus on emotional functioning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,810

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

May 14, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

May 12, 2020

Last Update Submit

July 21, 2021

Conditions

Keywords

CancerQuality of LifeCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Overall Quality of Life

    EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 (Quality of Life Questionnaire core 30) - The QLQ-C30 is a standardized cancer-specific 30-itemed instrument. Scores are transformed linearly to a zero to 100 scale. A higher score on the functional scale and the global Health related Quality of Life indicates better functioning. In the current study, the items addressing global quality of life and health: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be used to get a pure expression of QoL. The EORTC QLQ-C30 scores in this study will be compared with QoL for Danish Cancer patients in the period before COVID-19 (https://www.cancer.dk/dyn/resources/File/file/3/8373/1574778638/kraeftens-bekaempelses-barometerundersoegelse-2019.pdf). Results on overall QoL is listed on page 36.

    One measurement of EORTC QLQ-C30 and a survey created for the purpose will be performed through study completion, an average of 1 months

Study Arms (1)

Patients with cancer

Survey

Other: No intervention

Interventions

Patients will be sent a survey incl. EORTC QLQ-C30

Patients with cancer

Eligibility Criteria

Age18 Years - 125 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients are recruited at the Department of Oncology and the Department of Haemotology, Odense University Hospital, Denmark. Patients are either receiving cancer treatment or in follow-up for a cancer diagnosis

You may qualify if:

  • Patients with cancer
  • Patients who are receiving cancer treatment or patients in follow-up for a cancer diagnosis
  • Age 18+

You may not qualify if:

  • Patients without "eBoks" - a secure electronic mailbox used to receive digital mail from the private sector

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Haemotology, Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

Department of Oncology, Odense University Hospital

Odense C, 5000, Denmark

Location

MeSH Terms

Conditions

NeoplasmsCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Stefan S Jeppesen, MD, PhD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Oncology, Associate professor, PhD

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 15, 2020

Study Start

May 14, 2020

Primary Completion

July 21, 2020

Study Completion

July 21, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations