Cancer
Conditions
Keywords
COVID-19, Quality of Life, Anxiety, Stress, Mood, DASS-21, WHOQOL-BREF, CPDI
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.
Interventions
OTHERSurvey administration
Covid-19 Peritraumatic Distress Index, Depression Anxiety Stress Scale-21, WHO Quality of Life-BREF
Sponsors
University Hospital, Ghent
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Change from baseline in anxiety measured by the DASS-21-Anxiety; in terms of continues 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 |
| 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 |
Countries
Belgium
Outcome results
None listed