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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Other: Survey administration


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Quality of Life, Anxiety, Stress, Mood, DASS-21, WHOQOL-BREF, CPDI