Oncology-patient-reported Anxiety, Mood, and QoL During the COVID-19 Pandemic
Completed
- Conditions
- Cancer
- Interventions
- Other: Survey administration
- Registration Number
- NCT04340219
- Lead Sponsor
- University Hospital, Ghent
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 394
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cancer patients Survey administration Participants complete a survey consisting of sociodemographic information and self-administered questionnaires (CPDI, DASS-21, and WHOQOL-BREF).
- Primary Outcome Measures
Name Time Method 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 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 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 Distress at baseline measured by the COVID-19 Peritraumatic Distress Index (CPDI); in terms of proportions (0-28 vs ≥ 29). Week 0
- Secondary Outcome Measures
Name Time Method Depression at baseline measured by the DASS-21-Depression; 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 6-item psychological health domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF-Psychological health); 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 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 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 Distress measured at baseline by the CPDI; 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 Change from baseline in stress measured by the DASS-21-Stress; in terms of continuous values. 24 weeks 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 Change from baseline in depression measured by the DASS-21-Depression; in terms of continuous values. 24 weeks 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 anxiety measured by the DASS-21-Anxiety; in terms of continues 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 Anxiety at baseline measured by the DASS-21-Anxiety; in terms of continuous values. Week 0 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
Trial Locations
- Locations (1)
University Hospital Gent
🇧🇪Gent, Belgium