CancerONCOVIDNCT04340219
Oncology-patient-reported Anxiety, Mood, and QoL During the COVID-19 Pandemic
An observational study of Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Survey administration
- How many people
- 394 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Mar 2020to 18 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing systemic treatment at the Medical Oncology Department between February 14 and March 31, 2020.
Who may be able to join
- ≥ 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort Study Investigating Oncology-patient-reported Anxiety, Mood, and Quality of Life During the COVID-19 Pandemic (ONCOVID Trial)
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.
- Conditions
- Cancer
- Being tested
- Survey administration
- Keywords
- COVID-19, Quality of Life, Anxiety, Stress, Mood, DASS-21, WHOQOL-BREF, CPDI
- Medical subject headings
- Neoplasms, COVID-19, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey administrationOther
Covid-19 Peritraumatic Distress Index, Depression Anxiety Stress Scale-21, WHO Quality of Life-BREF
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | Participants complete a survey consisting of sociodemographic information and self-administered questionnaires (CPDI, DASS-21, and WHOQOL-BREF). Receives: Other: Survey administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress at baseline measured by the COVID-19 Peritraumatic Distress Index (CPDI); in terms of proportions (0-28 vs ≥ 29).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Week 0
Secondary outcomes (19)
Distress measured at baseline by the CPDI; in terms of continuous values.
Measured: Week 0
Depression at baseline measured by the DASS-21-Depression; in terms of continuous values.
Measured: Week 0
Anxiety at baseline measured by the DASS-21-Anxiety; in terms of continuous values.
Measured: Week 0
Stress at baseline measured by the DASS-21-Stress; in terms of continuous values.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 0
Change from baseline in distress measured by CDPI; in terms of continuous values.
Measured: 24 weeks
Change from baseline in depression measured by the DASS-21-Depression; in terms of continuous values.
Measured: 24 weeks
Change from baseline in anxiety measured by the DASS-21-Anxiety; in terms of continues values.
Measured: 24 weeks
Change from baseline in stress measured by the DASS-21-Stress; in terms of continuous values.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Social relationship; in terms of continuous values.
Measured: 24 weeks
Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Environment; in terms of continuous values.
Measured: 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.
Measured: 24 weeks
The real-life impact of COVID-19 on systemic treatment administration will be assessed using descriptive statistics
Measured: Week 0-6-12-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start30 Mar 2020
- Primary completion10 Apr 2020
- Study completion18 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hannelore Denys, MD, PhD, Principal investigator, Medical Oncologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340219
- Sponsor's protocol ID
- BC-07505-LGE
- Acronym
- ONCOVID
- Status last verified
- Mar 2020
- First submitted
- 31 Mar 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study Investigating Oncology-patient-reported Anxiety, Mood, and Quality of Life During the COVID-19 Pandemic (ONCOVID Trial)
- ClinicalTrials.gov ID
- NCT04340219
- Acronym / sponsor ID
- ONCOVID / BC-07505-LGE
- Conditions
- Cancer
- Keywords
- COVID-19, Quality of Life, Anxiety, Stress, Mood, DASS-21, WHOQOL-BREF, CPDI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 18 Sep 2020 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | Other: Survey administrationParticipants complete a survey consisting of sociodemographic information and self-administered questionnaires (CPDI, DASS-21, and WHOQOL-BREF). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing systemic treatment at the Medical Oncology Department between February 14 and March 31, 2020.
Key inclusion criteria (3 listed)
- ≥ 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)
Key exclusion criteria (6 listed)
- Insufficient understanding of the Dutch language
- Severe cognitive impairment
- Acute psychiatric crisis
- Not able to give informed consent
- Confirmed or clinically suspected COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey administrationCovid-19 Peritraumatic Distress Index, Depression Anxiety Stress Scale-21, WHO Quality of Life-BREF | Other | Cancer patients |
Primary outcome
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
19 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0
Change from baseline in distress measured by CDPI; in terms of continuous values.
Time frame: 24 weeks
Change from baseline in depression measured by the DASS-21-Depression; in terms of continuous values.
Time frame: 24 weeks
Change from baseline in anxiety measured by the DASS-21-Anxiety; in terms of continues values.
Time frame: 24 weeks
Change from baseline in stress measured by the DASS-21-Stress; in terms of continuous values.
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks
Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Social relationship; in terms of continuous values.
Time frame: 24 weeks
Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Environment; in terms of continuous values.
Time frame: 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.
Time frame: 24 weeks
The real-life impact of COVID-19 on systemic treatment administration will be assessed using descriptive statistics
Time frame: Week 0-6-12-24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannelore Denys, MD, PhD principal investigator
Medical Oncologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress at baseline measured by the COVID-19 Peritraumatic Distress Index (CPDI); in terms of proportions (0-28 vs ≥ 29). (time frame: Week 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.