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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04340219
Recruitment Status : Completed
First Posted : April 9, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cancer Other: Survey administration

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Study Type : Observational
Actual Enrollment : 394 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study Investigating Oncology-patient-reported Anxiety, Mood, and Quality of Life During the COVID-19 Pandemic (ONCOVID Trial)
Actual Study Start Date : March 30, 2020
Actual Primary Completion Date : April 10, 2020
Actual Study Completion Date : September 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  1. Distress at baseline measured by the COVID-19 Peritraumatic Distress Index (CPDI); in terms of proportions (0-28 vs ≥ 29). [ Time Frame: Week 0 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. Distress measured at baseline by the CPDI; in terms of continuous values. [ Time Frame: Week 0 ]
  2. Depression at baseline measured by the DASS-21-Depression; in terms of continuous values. [ Time Frame: Week 0 ]
  3. Anxiety at baseline measured by the DASS-21-Anxiety; in terms of continuous values. [ Time Frame: Week 0 ]
  4. Stress at baseline measured by the DASS-21-Stress; in terms of continuous values. [ Time Frame: Week 0 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. Change from baseline in distress measured by CDPI; in terms of continuous values. [ Time Frame: 24 weeks ]
  11. Change from baseline in depression measured by the DASS-21-Depression; in terms of continuous values. [ Time Frame: 24 weeks ]
  12. Change from baseline in anxiety measured by the DASS-21-Anxiety; in terms of continues values. [ Time Frame: 24 weeks ]
  13. Change from baseline in stress measured by the DASS-21-Stress; in terms of continuous values. [ Time Frame: 24 weeks ]
  14. 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 ]
  15. 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 ]
  16. 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 ]
  17. Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Environment; in terms of continuous values. [ Time Frame: 24 weeks ]
  18. 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 ]
  19. The real-life impact of COVID-19 on systemic treatment administration will be assessed using descriptive statistics [ Time Frame: Week 0-6-12-24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing systemic treatment at the Medical Oncology Department between February 14 and March 31, 2020.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340219


Locations
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Belgium
University Hospital Gent
Gent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Hannelore Denys, MD, PhD Medical Oncologist
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT04340219    
Other Study ID Numbers: BC-07505-LGE
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Ghent:
COVID-19
Quality of Life
Anxiety
Stress
Mood
DASS-21
WHOQOL-BREF
CPDI
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders