Clinical trial NCT04340219: Oncology-patient-reported Anxiety, Mood, and QoL During the COVID-19 Pandemic
Official title: A Prospective Cohort Study Investigating Oncology-patient-reported Anxiety, Mood, and Quality of Life During the COVID-19 Pandemic (ONCOVID Trial)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: COVID-19
Quality of Life
Anxiety
Stress
Mood
DASS-21
WHOQOL-BREF
CPDI
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing systemic treatment at the Medical Oncology Department between February 14 and March 31, 2020.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Distress at baseline measured by the COVID-19 Peritraumatic Distress Index (CPDI); in terms of proportions (0-28 vs ≥ 29).
timeFrame: Week 0
measure: 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).
timeFrame: Week 0
measure: 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).
timeFrame: Week 0
measure: 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).
timeFrame: Week 0
Secondary outcomes:
measure: Distress measured at baseline by the CPDI; in terms of continuous values.
timeFrame: Week 0
measure: Depression at baseline measured by the DASS-21-Depression; in terms of continuous values.
timeFrame: Week 0
measure: Anxiety at baseline measured by the DASS-21-Anxiety; in terms of continuous values.
timeFrame: Week 0
measure: Stress at baseline measured by the DASS-21-Stress; in terms of continuous values.
timeFrame: Week 0
measure: 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.
timeFrame: Week 0
measure: 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.
timeFrame: Week 0
measure: 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.
timeFrame: Week 0
measure: 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.
timeFrame: Week 0
measure: 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.
timeFrame: Week 0
measure: Change from baseline in distress measured by CDPI; in terms of continuous values.
timeFrame: 24 weeks
measure: Change from baseline in depression measured by the DASS-21-Depression; in terms of continuous values.
timeFrame: 24 weeks
measure: Change from baseline in anxiety measured by the DASS-21-Anxiety; in terms of continues values.
timeFrame: 24 weeks
measure: Change from baseline in stress measured by the DASS-21-Stress; in terms of continuous values.
timeFrame: 24 weeks
measure: Change from baseline in domain-specific quality of life at baseline measured by the WHOQOL-BREF-Physical health; in terms of continuous values.
timeFrame: 24 weeks
measure: Change from baseline in domain-specific quality of life at baseline measured by the WHOQOL-BREF-Psychological health; in terms of continuous values.
timeFrame: 24 weeks
measure: Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Social relationship; in terms of continuous values.
timeFrame: 24 weeks
measure: Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Environment; in terms of continuous values.
timeFrame: 24 weeks
measure: 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.
timeFrame: 24 weeks
measure: The real-life impact of COVID-19 on systemic treatment administration will be assessed using descriptive statistics
timeFrame: Week 0-6-12-24
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: University Hospital Gent
Study officials:
affiliation: Medical Oncologist
name: Hannelore Denys, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: