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Completed

NCT Number: NCT04340219

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

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.

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Key information

Conditions

Cancer Anxiety Disorders COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Neoplasms Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Gent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Survey Administration

Other

Covid-19 Peritraumatic Distress Index, Depression Anxiety Stress Scale-21, WHO Quality of Life-BREF

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: ONCOVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2020
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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