NCT04340219

Brief Summary

ONCOVID is a prospective cohort study investigating oncology-patient-reported anxiety, mood, and quality of life during the COVID-19 pandemic. Participants complete a survey consisting of sociodemographic information and self-administered questionnaires (COVID-19 Peritraumatic Distress Index, Depression Anxiety Stress Scale-21, and WHO Quality of Life-BREF). Data collection occurs at baseline and follow-up surveys are performed after 6, 12, and 24 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
394

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 30, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 31, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2020

Completed
Last Updated

September 25, 2020

Status Verified

March 1, 2020

Enrollment Period

11 days

First QC Date

March 31, 2020

Last Update Submit

September 24, 2020

Conditions

Cancer

Keywords

COVID-19Quality of LifeAnxietyStressMoodDASS-21WHOQOL-BREFCPDI

Outcome Measures

Primary Outcomes (4)

  • Distress at baseline measured by the COVID-19 Peritraumatic Distress Index (CPDI); in terms of proportions (0-28 vs ≥ 29).

    Week 0

  • Depression at baseline measured by the 7-item depression subscale of the 21-item Depression, Anxiety, and Stress Scale (DASS-21) (DASS-21-Depression); in terms of proportions (0-4 vs ≥ 5).

    Week 0

  • Anxiety at baseline measured by the 7-item anxiety subscale of the DASS-21 (DASS-21-Anxiety); in terms of proportions (0-3 vs ≥ 4).

    Week 0

  • Stress at baseline measured by the 7-item stress subscale of the DASS-21 (DASS-21-Stress); in terms of proportions (0-7 vs ≥ 8).

    Week 0

Secondary Outcomes (19)

  • Distress measured at baseline by the CPDI; in terms of continuous values.

    Week 0

  • Depression at baseline measured by the DASS-21-Depression; in terms of continuous values.

    Week 0

  • Anxiety at baseline measured by the DASS-21-Anxiety; in terms of continuous values.

    Week 0

  • Stress at baseline measured by the DASS-21-Stress; in terms of continuous values.

    Week 0

  • Domain-specific quality of life at baseline measured by the 7-item physical health domain of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire (WHOQOL-BREF-Physical health); in terms of continuous values.

    Week 0

  • +14 more secondary outcomes

Study Arms (1)

Cancer patients

Participants complete a survey consisting of sociodemographic information and self-administered questionnaires (CPDI, DASS-21, and WHOQOL-BREF).

Other: Survey administration

Interventions

Survey administrationOTHER

Covid-19 Peritraumatic Distress Index, Depression Anxiety Stress Scale-21, WHO Quality of Life-BREF

Cancer patients

Eligibility Criteria

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

All patients undergoing systemic treatment at the Medical Oncology Department between February 14 and March 31, 2020.

You may qualify if:

  • ≥ 18 years of age
  • Histologically confirmed cancer

You may not qualify if:

  • Insufficient understanding of the Dutch language
  • Severe cognitive impairment
  • Acute psychiatric crisis
  • Not able to give informed consent
  • Confirmed or clinically suspected COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Gent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

NeoplasmsCOVID-19Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hannelore Denys, MD, PhD

    Medical Oncologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 9, 2020

Study Start

March 30, 2020

Primary Completion

April 10, 2020

Study Completion

September 18, 2020

Last Updated

September 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)