- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02577237
Building Caregiver Skills Using a Simulation-based Intervention for Care of Head and Neck Cancer
Building Family Caregiver Skills Using a Simulation-based Intervention for Care of Patients With Head and Neck Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Aim 1: Conduct a pilot test of the effects of a novel caregiver intervention, as compared to a control group, on family caregiver self-efficacy for caregiving, anxiety, depression, and health-related quality of life.
Aim 2: Explore the acceptability of a caregiver intervention that utilizes simulation.
Aim 3: Assess the feasibility of the intervention. Aim 4: Describe the incidence of patient events that may be impacted by caregiver self-efficacy, such as acute care visits, admissions to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- family member or friend of an adult patient with a new diagnosis of Stage III - IV cancers of the tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, larynx, or parotid who is receiving radiation therapy for curative intent
- identified by the patient as his/her primary caregiver who is providing daily assistance and/or emotional support
- cognitively intact, as evidenced by orientation to person, place, and time
- ability to speak, read, and comprehend English
Exclusion Criteria:
- Caregivers of patients who are receiving hospice care will be excluded because of the patient's poor prognosis and multiple issues associated with end-of-life care
- Caregivers who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention Group: Caregiver education
The intervention includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses.
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The intervention will be delivered by a radiation oncology nurse.
Each of the four in-person sessions consists of approximately 30 minutes of educational content/simulation that addresses a specific caregiving topic and any issues or concerns that the caregiver may be experiencing.
Otros nombres:
written, qualitative assessments of areas including depression and anxiety, caregiver self-efficacy, care-giver self efficacy for head and neck cancer, health-related quality of life, patient performance status, demographics, and medical history.
A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.
Otros nombres:
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Comparador activo: Control Group: educational booklet
The control group will receive an educational booklet about caregiving in addition to usual care by their doctors and nurses
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written, qualitative assessments of areas including depression and anxiety, caregiver self-efficacy, care-giver self efficacy for head and neck cancer, health-related quality of life, patient performance status, demographics, and medical history.
A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.
Otros nombres:
Radiation Oncology Nurse will hand participant the NCI booklet
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Average efficacy of caregiving summary score
Periodo de tiempo: Up to 5 weeks
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Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically.
Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
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Up to 5 weeks
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Average anxiety summary score
Periodo de tiempo: Up to 5 weeks
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Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically.
Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
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Up to 5 weeks
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Average depression summary score
Periodo de tiempo: Up to 5 weeks
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Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically.
Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
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Up to 5 weeks
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Average Health Related Quality of Life (HRQOL) summary score
Periodo de tiempo: Up to 5 weeks
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Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically.
Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
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Up to 5 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Qualitative assessment of acceptability
Periodo de tiempo: Up to 5 weeks
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Descriptive statistics will be used to summarize responses to semi-structured interviews
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Up to 5 weeks
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Attrition rate to assess feasibility
Periodo de tiempo: Up to 5 weeks
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Feasibility will be assessed via attrition and consent rates.
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Up to 5 weeks
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Consent rate to assess feasibility
Periodo de tiempo: Up to 5 weeks
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Feasibility will be assessed via attrition and consent rates.
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Up to 5 weeks
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Total time for delivering intervention to assess costs
Periodo de tiempo: Up to 5 weeks
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Time for delivering the intervention will be recorded to aid in assessing costs.
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Up to 5 weeks
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Average missed checklist items to assess integrity of intervention
Periodo de tiempo: Up to 5 weeks
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Integrity of the intervention will be assessed through monitoring of intervention checklist.
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Up to 5 weeks
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Event rate for patient events
Periodo de tiempo: Up to 5 weeks
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Describe the average incidence of all patient events that may be impacted by caregiver self-efficacy.
Events may include acute care visits, admission to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course, and others
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Up to 5 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Susan Mazanec, PhD, RN, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CASE2315
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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