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ReclutandoNCT04551378Registro de ClinicalTrials.gov

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

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio
Observacional
Fase
No aplica / no indicada
Rango de edad
18 años - 39 años
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
600 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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

Población del estudio

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

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No informado
Enmascaramiento
No informado
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

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Coronavirus disease 2019 (COVID-19) specific psychological stress

Plazo: 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.

Medidas secundarias

Survey responses

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: 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.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

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1 centros

M D Anderson Cancer CenterHouston, Texas, United StatesReclutando
Michael E Roth, PHDCONTACTMChang1@mdanderson.org713-792-7751
Michael E Roth, MDPRINCIPAL_INVESTIGATOR
Ver ubicación en el mapa ↗

Equipo y fechas

Patrocinador principal
M.D. Anderson Cancer Center
Inicio del estudio
13 jul 2020 Real
Finalización primaria
31 dic 2028 Estimado
Finalización del estudio
31 dic 2028 Estimado
Primera publicación
16 sept 2020 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Michael E Roth, MDCONTACTMRoth1@mdanderson.org713-792-7751
Título oficial del estudio

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

EL PRÓXIMO PASO, CON APOYO HUMANO

Consulta a Wellness Clinical Research

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026