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Recruiting NCT04551378

The Effect of COVID-19 Pandemic on Adolescent and Young Adult Cancer Patients and Survivors

Observational COVID-19 Infection Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Quality-of-Life Assessment, Survey Administration.
Who it may be relevant to
Registry conditions: COVID-19 Infection, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm. Basic parameters: 18 years — 39 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impacts of Coronavirus Disease 2019 (COVID-19) Pandemic on Adolescent and Young Adult (AYA) Cancer Patients and Survivors

Overview

The study investigates how the COVID-19 pandemic has impacted the psychological, financial, physical, and social well-being of adolescent and young adult (AYA) cancer patients and survivors. AYA cancer survivors have inferior long-term survival compared to the general population, and the negative impact of the global COVID-19 pandemic may be even higher in this vulnerable group. The information gained from this study may provide an opportunity to determine the self-reported COVID-19 specific psychological distress in AYA cancer survivors, and may lead to the development of a targeted intervention to improve physical and psychosocial health for AYA cancer patients and survivors.

Detailed description

PRIMARY OBJECTIVE:

I. To determine the self-reported coronavirus disease 2019 (COVID-19) specific psychological distress in adolescent and young adult (AYA) cancer survivors diagnosed between the ages of 15 to 39 and are currently between the ages of 18 to 39.

SECONDARY OBJECTIVES:

I. To determine the COVID-19 specific health care utilization, health behavior, financial and social disruptions, and health-related quality of life (HRQoL).

II. To determine associations between patient demographic and treatment-related variables with COVID-19 specific psychological distress, healthcare utilization, health behavior, financial and social disruptions, and HRQoL.

III. To determine associations between resilience factors (i.e., social support, perceived benefits under times of stress, and the ability to manage stress) with self-reported COVID-19 specific psychological distress, healthcare utilization, health behavior, financial and social disruptions, and HRQoL.

IV. To determine the changes in COVID-19 specific psychosocial distress, healthcare utilization, health behavior, financial, and social disruptions.

OUTLINE:

Patients and survivors complete a survey online over 20-30 minutes at baseline about COVID-19 specific psychological distress, health care utilization, health behavior, social and financial disruptions, HRQoL, their social support, perceived benefits under times of stress, and the ability to manage stress. Patients and survivors may be contacted again at 6 months and 1 year for COVID-19 research.

Interventions

  • Other Quality-of-Life Assessment
    Ancillary studies
  • Other Survey Administration
    Complete survey

Primary outcome measures

  • Coronavirus disease 2019 (COVID-19) specific psychological stress [Time frame: At baseline, 6 months, and 12 months]
Secondary outcome measures (5)
  • Survey responses [Time frame: At baseline, 6 months, and 12 months]
  • Patient reported outcomes [Time frame: At baseline, 6 months, and 12 months]
  • Changes of survey responses [Time frame: At baseline, 6 months, and 12 months]
  • Changes in discrete responses [Time frame: At baseline, 6 months, and 12 months]
  • Incidence of survey question non-response [Time frame: At baseline, 6 months, and 12 months]

Eligibility criteria

Inclusion criteria

  • PATIENT COHORT INCLUSION:
  • Initial cancer diagnosis between the ages of 15 to 39
  • Received any cancer treatment at MD Anderson Cancer Center with data available in the MD Anderson Cancer Center Tumor Registry
  • For questionnaire provision: confirmed alive at time of contact

Exclusion criteria

  • PATIENT COHORT EXCLUSION:
  • Inability to complete questionnaires in English
  • Seen at MD Anderson for a second opinion or non-treatment related visit

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT04551378 · 2020-0504 · NCI-2020-06609 · 2020-0504

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗