Clinical trial NCT04551378: The Effect of COVID-19 Pandemic on Adolescent and Young Adult Cancer Patients and Survivors
Official title: Impacts of Coronavirus Disease 2019 (COVID-19) Pandemic on Adolescent and Young Adult (AYA) Cancer Patients and Survivors
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: 2020-09-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients and survivors diagnosed between the ages of 15 to 39 years, and whose data is available in the MD Anderson Cancer Center Tumor Registry

Brief summary: 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.

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

Primary outcomes:
measure: Coronavirus disease 2019 (COVID-19) specific psychological stress
timeFrame: At baseline, 6 months, and 12 months
Secondary outcomes:
measure: Survey responses
timeFrame: At baseline, 6 months, and 12 months
measure: Patient reported outcomes
timeFrame: At baseline, 6 months, and 12 months
measure: Changes of survey responses
timeFrame: At baseline, 6 months, and 12 months
measure: Changes in discrete responses
timeFrame: At baseline, 6 months, and 12 months
measure: Incidence of survey question non-response
timeFrame: At baseline, 6 months, and 12 months
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: Maria Swartz, PHD
role: PRINCIPAL_INVESTIGATOR
References: