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

University Hospital, Ghent394 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

394

Conditions

Cancer

Interventions

Survey administrationOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University Hospital Gent

Ghent, Belgium

Outcomes

Primary Outcomes

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

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: Week 0

Secondary Outcomes

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

Time frame: Week 0

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

Time frame: Week 0

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

Time frame: Week 0

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

Time frame: 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.

Time frame: Week 0

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.