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Clinical Model in Evaluating Clinical, Psychosocial, and Health Economic Factors in Adolescent and Young Adult Patients With Cancer

5 de agosto de 2022 actualizado por: University of Southern California

Adolescent and Young Adult (AYA) Cancers Clinical Model: An Evaluation of the AYA Clinical Care Model by Assessment of Clinical, Psychosocial, and Health Economic Factors Related to AYA Patient Outcomes

This research trial studies the Adolescent and Young Adult (AYA) Cancers Clinical Model in evaluating clinical, psychosocial, and health economic factors in adolescent and young adult patients with cancer. Studying the Adolescent and Young Adult Cancers Clinical Model may help doctors learn more about the effect of the AYA services on patient care, including clinical (nurse navigation), psychosocial (social work), and economic (financial) areas.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

PRIMARY OBJECTIVES:

I. To provide economic understanding of the AYA at University of Southern California (USC) model of care. (Norris)

II. To evaluate the existing AYA at USC program to determine the direct and indirect impact on cost of care. (Norris)

III. To utilize the results of objective (i) to identify cost effectiveness and efficiencies to patient and institution. (Norris)

IV. To identify specific processes within our model of care that can be improved. (Norris)

V. To improve healthcare access to AYA-specific cancer care for patients ages 15-39 served by the Los Angeles County (LAC)+USC oncology pilot clinics. (LAC+USC)

VI. To improve the psychosocial outcome of AYA-specific cancer care patients. (LAC+USC)

VII. To provide AYA specific elements of care routinely and proactively to AYA cancer patients. (LAC+USC)

VIII. To improve care quality through patient satisfaction. (LAC+USC)

IX. To improve resource utilization and care coordination through improved patient navigation through efficiency and patient navigation. (LAC+USC)

OUTLINE:

Patients complete questionnaires at referral, week 4-8, week 10-12, and at the completion of systemic therapy.

Tipo de estudio

De observación

Inscripción (Actual)

76

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90033
        • USC / Norris Comprehensive Cancer Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

15 años a 39 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Adolescent and Young Adult (AYA) with cancer who are being seen at the USC/Norris Cancer Center and at LAC+USC Medical Center.

Descripción

Inclusion Criteria:

  • Patients diagnosed with cancer
  • ADDITIONAL GRANT SPECIFIC INCLUSION CRITERIA - UNIHEALTH (NORRIS):
  • Patients who were diagnosed at USC Norris Comprehensive Cancer Center and Hospital
  • Patients who are currently receiving treatment for a primary or secondary tumor at USC Norris Comprehensive Cancer Center and Hospital
  • ADDITIONAL GRANT SPECIFIC INCLUSION CRITERIA - QUEENSCARE (LAC + USC):
  • Patients who are being seen in sarcoma, gynecologic oncology, or genitourinary clinic at LAC + USC (clinics A2C or 4P1)
  • Patients who are currently receiving treatment for a primary or secondary tumor at LAC + USC and who receive oncology care from one of the clinics above
  • Patients who are at or below the poverty level

Exclusion Criteria:

  • Inability to sign informed assent and/or consent
  • Patients who are not receiving chemotherapy and/or radiation therapy for a primary or secondary tumor
  • Primary oncology treatment team believes that participation in AYA at USC would not benefit their patient
  • ADDITIONAL GRANT SPECIFIC EXCLUSION CRITERIA - UNIHEALTH (NORRIS):
  • Patients who are not receiving treatment for a primary or secondary tumor at USC Norris Comprehensive Cancer Center and Hospital
  • ADDITIONAL GRANT SPECIFIC EXCLUSION CRITERIA - QUEENSCARE (LAC+USC):
  • Patients who are not receiving oncology care for a primary or secondary tumor in sarcoma, gynecologic oncology, or genitourinary clinic at LAC + USC (clinics A2C or 4P1)
  • Patients who are above the poverty level

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Solo caso
  • Perspectivas temporales: Futuro

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Observational (questionnaires)
Patients complete questionnaires at referral, week 4-8, week 10-12, and at the completion of systemic therapy.
Otro: Evaluación de la calidad de vida
Estudios complementarios
Otros nombres:
  • Evaluación de la calidad de vida
Otro: Administración del Cuestionario
Estudios complementarios

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical care model impact on patient access to AYA specific supportive care as assessed by questionnaires (Norris)
Periodo de tiempo: Up to 2 years
Questionnaire scores will be expressed as median values with 95% confidence intervals.
Up to 2 years
Clinical care model impact on patient's/health care professional's satisfaction with the AYA at USC program as assessed by questionnaires (LAC+USC)
Periodo de tiempo: Up to 2 years
Questionnaire scores will be expressed as median values with 95% confidence intervals.
Up to 2 years
Cost of care (Norris)
Periodo de tiempo: Up to 2 years
Direct health care costs analyses will be performed from the Total Costs of Care payer perspective. Direct cost will be estimated from paid claims in the extracted electronic medical records, which will include costs for all health care utilization such as outpatient, procedures, laboratory, emergency room visits, hospitalization, and pharmacy. As the healthcare utilization and costs will likely be extremely skewed, healthcare utilization and cost measures will be estimated by using an econometric model (e.g., a negative binomial regression model for utilization count data [number of services
Up to 2 years
Incremental cost (Norris)
Periodo de tiempo: Up to 2 years
The incremental cost between AYA enrolled and non-enrolled will be calculated. In addition to estimation the magnitude of the variability attributed to the different sources of variation, we will also generate an influence diagram (also known as tornado diagram) to display which variables exert the most influence on cost driver.
Up to 2 years
Processes that can be improved (Norris)
Periodo de tiempo: Up to 2 years
Will utilize the prospective data to estimate key aspects of the AYA at USC service. Any variances in the services over time will be utilized to improve quality and reliability care delivery.
Up to 2 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Care coordination as assessed by the mean number of supportive care referrals, telephone or email encounters for additional information, educational materials, and or additional interventions provided by the nurse navigator and/or social worker (LAC+USC)
Periodo de tiempo: Up to 2 years
Will be measured using an implementation guide.
Up to 2 years
Patient continuity of care as assessed by the mean number of visits per patient with the assigned clinic lead physician (LAC+USC)
Periodo de tiempo: Up to 2 years
Will be measured using an implementation guide.
Up to 2 years
Resource allocation as assessed by the mean number of supportive care referrals and per patient follow-up conducted by the nurse navigator and/or social worker (LAC+USC)
Periodo de tiempo: Up to 2 years
Will be measured using an implementation guide.
Up to 2 years
Satisfaction of health care staff as assessed by questionnaires (LAC+USC)
Periodo de tiempo: Up to 2 years
Questionnaire scores will be expressed as median values with 95% confidence intervals.
Up to 2 years
Satisfaction of services as assessed by questionnaires (LAC+USC)
Periodo de tiempo: Up to 2 years
Questionnaire scores will be expressed as median values with 95% confidence intervals.
Up to 2 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Southern California

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: James Hu, MD, University of Southern California

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

3 de febrero de 2017

Finalización primaria (Actual)

30 de noviembre de 2021

Finalización del estudio (Actual)

30 de noviembre de 2021

Fechas de registro del estudio

Enviado por primera vez

15 de febrero de 2017

Primero enviado que cumplió con los criterios de control de calidad

15 de febrero de 2017

Publicado por primera vez (Actual)

20 de febrero de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de agosto de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

5 de agosto de 2022

Última verificación

1 de agosto de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 0S-16-6 (Otro identificador: USC / Norris Comprehensive Cancer Center)
  • P30CA014089 (Subvención/contrato del NIH de EE. UU.)
  • NCI-2017-00210 (Identificador de registro: CTRP (Clinical Trial Reporting Program))

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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