Clinical trial NCT04500600: Well-Being and Health-Related Quality of Life in Cancer Patients and Survivors During the COVID-19 Pandemic
Official title: Well-Being and Quality of Life in Cancer Patients and Survivors During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Infection
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-08-05
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a confirmed cancer diagnosis and cancer survivors

Brief summary: This study investigates the well-being and health-related quality of life in cancer patients and survivors during the COVID-19 pandemic. Using questionnaires may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

Detailed description: PRIMARY OBJECTIVES:

I. Assess experiences during the coronavirus disease 2019 (COVID-19) pandemic (e.g., exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss of family or friends); COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms); health, financial and social disruptions; perceived benefits and social support; and health-related quality of life (HRQoL) in a convenience sample of cancer patients and survivors.

II. Evaluate the extent to which COVID-19 experiences are associated with COVID-19-specific psychological distress, health, financial and social disruptions, perceived benefits and social support, and HRQoL.

III. Evaluate the extent to which resiliency factors such as social support and perceived benefits moderate the effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL.

OUTLINE:

Patients complete an online questionnaire over 10 minutes regarding the COVID-19 pandemic including testing, risks of exposure, whether people they know have acquired COVID-19, as well as questions on how the pandemic has impacted their quality of life.

Eligibility criteria: Inclusion Criteria:

* MD Anderson active patient (visit within past 5 years)
* ICD-10 confirmed cancer diagnosis
* Documentation of being alive per the cancer registry
* Patients who have signed consent for one of the following protocols: PA14-0241 or LAB03-0320
* Has an active email address and/or can be contacted via MyChart
* English or Spanish speaker

Exclusion Criteria:

* Non-active patient (i.e., no visit within past 5 years)
* Language other than English or Spanish
* Patients who have previously consented to the following protocols: 2012-0112, 2009-0976, 2005-0035, or PA15-0336, because they will be contacted through separate IRB protocols to complete this same survey

Primary outcomes:
measure: Experiences during the coronavirus disease 2019 (COVID-19) pandemic
timeFrame: 2 months
measure: COVID-19-specific psychological distress
timeFrame: Up to 2 months
measure: COVID-19-specific health
timeFrame: Up to 2 months
measure: COVID-19-specific financial and social disruptions
timeFrame: Up to 2 months
measure: COVID-19-specific perceived benefits and social support
timeFrame: Up to 2 months
measure: COVID-19-specific health related quality of life (HRQoL)
timeFrame: Up to 2 months
measure: Effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorenzo Cohen
role: PRINCIPAL_INVESTIGATOR
References: