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Well-Being and Health-Related Quality of Life in Cancer Patients and Survivors During the COVID-19 Pandemic

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04500600
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : July 14, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
COVID-19 Infection Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Other: Quality-of-Life Assessment Other: Questionnaire Administration

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.

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Study Type : Observational
Estimated Enrollment : 50000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Well-Being and Quality of Life in Cancer Patients and Survivors During the COVID-19 Pandemic
Actual Study Start Date : June 11, 2020
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observational (questionnaire)
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Complete questionnaire




Primary Outcome Measures :
  1. Experiences during the coronavirus disease 2019 (COVID-19) pandemic [ Time Frame: 2 months ]
    This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire 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.

  2. COVID-19-specific psychological distress [ Time Frame: Up to 2 months ]
    This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire 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.

  3. COVID-19-specific health [ Time Frame: Up to 2 months ]
    This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire 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.

  4. COVID-19-specific financial and social disruptions [ Time Frame: Up to 2 months ]
    This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire 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.

  5. COVID-19-specific perceived benefits and social support [ Time Frame: Up to 2 months ]
    This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire 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.

  6. COVID-19-specific health related quality of life (HRQoL) [ Time Frame: Up to 2 months ]
    This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire 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.

  7. Effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL [ Time Frame: Up to 2 months ]
    Will 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Adult patients with a confirmed cancer diagnosis and cancer survivors
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

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): NCT04500600


Contacts
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Contact: Lorenzo Cohen (713) 745-4260 lcohen@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lorenzo Cohen       lcohen@mdanderson.org   
Principal Investigator: Lorenzo Cohen         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lorenzo Cohen M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04500600    
Other Study ID Numbers: 2020-0473
NCI-2020-04604 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0473 ( Other Identifier: M D Anderson Cancer Center )
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: July 14, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Neoplasms
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases