Oncology-patient-reported Anxiety, Mood, and QoL During the COVID-19 Pandemic (ONCOVID)

A Prospective Cohort Study Investigating Oncology-patient-reported Anxiety, Mood, and Quality of Life During the COVID-19 Pandemic (ONCOVID Trial)

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Survey administration

• Study Type: Observational
• Enrollment (Actual): 394

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • University Hospital Gent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• ≥ 18 years of age
• Histologically confirmed cancer
• Receive systemic therapy (including chemotherapy, targeted small-molecule therapy, anticancer monoclonal antibody, immunotherapy, endocrine therapy, or investigational agent) (either exclusively or in combination with other anticancer therapy) between February 14, 2020 and March 31, 2020 (Note: Patients whose systemic treatment administration was initially planned for this period but was modified, delayed, stopped, or withheld due to COVID-19 measures are also eligible for inclusion)

Exclusion Criteria:

• Insufficient understanding of the Dutch language
• Severe cognitive impairment
• Acute psychiatric crisis
• Not able to give informed consent
• Confirmed or clinically suspected COVID-19
• Endocrine therapy in (neo)adjuvant setting (Note: Patients whose (neo)adjuvant systemic treatment was initially planned as chemotherapy, targeted small-molecule therapy, anticancer monoclonal antibody, immunotherapy, or investigational agent (either exclusively or in combination in combination with other anticancer therapy) but was modified to endocrine therapy due to COVID-19 measures are also eligible for inclusion)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer patients; Participants complete a survey consisting of sociodemographic information and self-administered questionnaires (CPDI, DASS-21, and WHOQOL-BREF).	Other: Survey administration; Covid-19 Peritraumatic Distress Index, Depression Anxiety Stress Scale-21, WHO Quality of Life-BREF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Domain-specific quality of life at baseline measured by the 6-item psychological health domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF-Psychological health); in terms of continuous values.	Week 0
Domain-specific quality of life at baseline measured by the 3-item social relationships domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF-Social relationships); in terms of continuous values.	Week 0
Domain-specific quality of life at baseline measured by the 8-item environment domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF-Environment); in terms of continuous values.	Week 0
Overall perception of quality of life and overall perception of health at baseline measured by the two items from the Overall QOL and General Health in the WHOQOL-BREF questionnaire-in terms of continuous values.	Week 0
Change from baseline in distress measured by CDPI; in terms of continuous values.	24 weeks
Change from baseline in depression measured by the DASS-21-Depression; in terms of continuous values.	24 weeks
Change from baseline in anxiety measured by the DASS-21-Anxiety; in terms of continues values.	24 weeks
Change from baseline in stress measured by the DASS-21-Stress; in terms of continuous values.	24 weeks
Change from baseline in domain-specific quality of life at baseline measured by the WHOQOL-BREF-Physical health; in terms of continuous values.	24 weeks
Change from baseline in domain-specific quality of life at baseline measured by the WHOQOL-BREF-Psychological health; in terms of continuous values.	24 weeks
Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Social relationship; in terms of continuous values.	24 weeks
Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Environment; in terms of continuous values.	24 weeks
Change from baseline in overall perception of quality of life and overall perception of health measured by the 2 items from the Overall QOL and General Health in the WHOQOL-BREF questionnaire; in terms of continuous values.	24 weeks
The real-life impact of COVID-19 on systemic treatment administration will be assessed using descriptive statistics	Week 0-6-12-24

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Hannelore Denys, MD, PhD, Medical Oncologist

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2020
• Primary Completion (Actual): April 10, 2020
• Study Completion (Actual): September 18, 2020

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Quality of Life; Anxiety; Stress; COVID-19; Mood; WHOQOL-BREF; DASS-21; CPDI
• 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: BC-07505-LGE

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