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RecruitingNCT04551378ClinicalTrials.gov record

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

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

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Observational
Phase
Not applicable / not listed
Age range
18 years - 39 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
600 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not reported
Masking
Not reported
Observational (survey)

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.

Other: Quality-of-Life Assessment · Other: Survey Administration

Quality-of-Life Assessment OTHER

Ancillary studies

Survey Administration OTHER

Complete survey

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Coronavirus disease 2019 (COVID-19) specific psychological stress

Time frame: At baseline, 6 months, and 12 months

Assessed per responses to the 12 questions pertaining to COVID-19 specific psychological stress within the adolescent and young adults (AYA) Cancer Survivor COVID-19 Survey section titled, "COVID-19 Related Distress (Emotional and Physical Reactions) and Health Behaviors.'' This survey includes both a 5-level Likert scale for the respondent's current level of concern (Not at all, A little, Neutral, A lot, Very Much), plus an ordinal 3-level scale for the respondent to rate the perceived level of change compared to before COVID-19 (Less, Same, More). Responses to individual questions will be summarized at each time point as means (for the Likert scale) and percentages (for discrete levels of change), together with 95% confidence intervals. For each question, will also summarize the percentages of patients in each group checking one of the 3 levels (Less, Same, More) indicating whether they perceived a change in that question since before COVID-19.

Secondary measures

Survey responses

Time frame: At baseline, 6 months, and 12 months

Will be summarized by group and time point. Associations between endpoints and demographic, treatment-related and resilience variables, as well as differences among groups will be assessed by t-test, analysis of variance or Chi-square test. Non-parametric tests (Wilcoxon rank sum, Kruskal-Wallis, Fisher's exact) will be employed when appropriate. Regression models (e.g., linear, logistic etc.) will also be employed. Change from baseline to subsequent time points in Likert scores will be modeled by mixed-effect models, while blocking on patient to control for repeated measures. Models will include baseline demographic, treatment-related, and resilience factor variables as covariates.

Patient reported outcomes

Time frame: At baseline, 6 months, and 12 months

Will be summarized by group and time point. Associations between endpoints and demographic, treatment-related and resilience variables, as well as differences among groups will be assessed by t-test, analysis of variance or Chi-square test. Non-parametric tests (Wilcoxon rank sum, Kruskal-Wallis, Fisher's exact) will be employed when appropriate. Regression models (e.g., linear, logistic etc.) will also be employed. Change from baseline to subsequent time points in Likert scores will be modeled by mixed-effect models, while blocking on patient to control for repeated measures. Models will include baseline demographic, treatment-related, and resilience factor variables as covariates.

Changes of survey responses

Time frame: At baseline, 6 months, and 12 months

Will be summarized by group and time point. Associations between endpoints and demographic, treatment-related and resilience variables, as well as differences among groups will be assessed by t-test, analysis of variance or Chi-square test. Non-parametric tests (Wilcoxon rank sum, Kruskal-Wallis, Fisher's exact) will be employed when appropriate. Regression models (e.g., linear, logistic etc.) will also be employed. Change from baseline to subsequent time points in Likert scores will be modeled by mixed-effect models, while blocking on patient to control for repeated measures. Models will include baseline demographic, treatment-related, and resilience factor variables as covariates.

Changes in discrete responses

Time frame: At baseline, 6 months, and 12 months

Will be summarized by group and time point. Associations between endpoints and demographic, treatment-related and resilience variables, as well as differences among groups will be assessed by t-test, analysis of variance or Chi-square test. Non-parametric tests (Wilcoxon rank sum, Kruskal-Wallis, Fisher's exact) will be employed when appropriate. Regression models (e.g., linear, logistic etc.) will also be employed. Change from baseline to subsequent time points in Likert scores will be modeled by mixed-effect models, while blocking on patient to control for repeated measures. Models will include baseline demographic, treatment-related, and resilience factor variables as covariates.

Incidence of survey question non-response

Time frame: At baseline, 6 months, and 12 months

Will be separately modeled by logistic regression with relation to group and time point as well as demographic and cancer characteristics in order to assess factors associated with non-response and to assess associated bias. Other statistical approaches might be used as appropriate.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

M D Anderson Cancer CenterHouston, Texas, United StatesRecruiting
Michael E Roth, PHDCONTACTMChang1@mdanderson.org713-792-7751
Michael E Roth, MDPRINCIPAL_INVESTIGATOR
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Study team and timeline

Lead sponsor
M.D. Anderson Cancer Center
Study start
Jul 13, 2020 Actual
Primary completion
Dec 31, 2028 Estimated
Study completion
Dec 31, 2028 Estimated
First posted
Sep 16, 2020 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Michael E Roth, MDCONTACTMRoth1@mdanderson.org713-792-7751
Official study title

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

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026