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

NCT ID: NCT04340219

Last Updated: 2020-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

394 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-30

Study Completion Date

2020-09-18

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.

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer patients

Participants complete a survey consisting of sociodemographic information and self-administered questionnaires (CPDI, DASS-21, and WHOQOL-BREF).

Survey administration

Intervention Type OTHER

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

Interventions

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Survey administration

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

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hannelore Denys, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Oncologist

Locations

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University Hospital Gent

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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BC-07505-LGE

Identifier Type: -

Identifier Source: org_study_id

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