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

Cancer Clinical Trial

— ONCOVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340219
• Other study ID #: BC-07505-LGE
• Status: Completed
• Start date: March 30, 2020
• Est. completion date: September 18, 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: September 18, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Cancer

Intervention

Other:
• Survey administration
Covid-19 Peritraumatic Distress Index, Depression Anxiety Stress Scale-21, WHO Quality of Life-BREF

Locations

Country	Name	City	State
Belgium	University Hospital Gent	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distress at baseline measured by the COVID-19 Peritraumatic Distress Index (CPDI); in terms of proportions (0-28 vs = 29).		Week 0
Primary	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
Primary	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
Primary	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	Distress measured at baseline by the CPDI; in terms of continuous values.		Week 0
Secondary	Depression at baseline measured by the DASS-21-Depression; in terms of continuous values.		Week 0
Secondary	Anxiety at baseline measured by the DASS-21-Anxiety; in terms of continuous values.		Week 0
Secondary	Stress at baseline measured by the DASS-21-Stress; in terms of continuous values.		Week 0
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline in distress measured by CDPI; in terms of continuous values.		24 weeks
Secondary	Change from baseline in depression measured by the DASS-21-Depression; in terms of continuous values.		24 weeks
Secondary	Change from baseline in anxiety measured by the DASS-21-Anxiety; in terms of continues values.		24 weeks
Secondary	Change from baseline in stress measured by the DASS-21-Stress; in terms of continuous values.		24 weeks
Secondary	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
Secondary	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
Secondary	Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Social relationship; in terms of continuous values.		24 weeks
Secondary	Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Environment; in terms of continuous values.		24 weeks
Secondary	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
Secondary	The real-life impact of COVID-19 on systemic treatment administration will be assessed using descriptive statistics		Week 0-6-12-24