Supportive Care Intervention-Pancreas (SCI-P)
10 de mayo de 2016 actualizado por: Yael Schenker, MD, MAS, University of Pittsburgh
A Pilot Trial of an Embedded Collaborative Model of Supportive Care for Pancreatic Cancer
This is a pilot, randomized controlled trial of an embedded collaborative model of supportive care designed to improve quality of life and decrease use of unwanted healthcare services at the end of life for patients with advanced pancreatic cancer.
We will enroll 30 patients who are receiving treatment at the Hillman Cancer Center for recently diagnosed, locally advanced or metastatic pancreatic adenocarcinoma, as well as their accompanying caregivers and providers.
Patients will be randomized to receive either the supportive care intervention or usual care.
The purpose of this study is to refine an embedded collaborative model of supportive care and to develop protocols for recruitment, randomization, and longitudinal data collection.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
Fase
- No aplica
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
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15232
- University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center
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-
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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Patients:
- Adults (≥ 18 years old)
- Pathologically-confirmed locally advanced or metastatic pancreatic adenocarcinoma diagnosed within the past 8 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 (asymptomatic), 1 (symptomatic but fully ambulatory), or 2 (symptomatic and in bed <50% of the day)
- Planning to receive continued care from an oncologist at the Hillman Cancer Center
- Accompanied by a caregiver (family member or friend) at the first visit
Caregivers:
- Adults (>= 18 years old)
- Family member or friend of an eligible patient
Exclusion Criteria:
Patients:
- Unable to read and respond to questions in English
- Not planning to receive continued care from an oncologist at the Hillman Cancer Center
- Pancreatic neuroendocrine cancer
Caregivers:
- Unable to read and respond to questions in English
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
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Supportive Care Intervention
Monthly (minimum) patient & caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers).
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Sin intervención: Usual Care
Participants will receive standard oncology care from their oncology providers.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
trial feasibility
Periodo de tiempo: up to 2 years
|
We will assess trial feasibility by monitoring number of eligible patients per clinic day, contact rates, interest rates, enrollment rates, randomization rates, intervention visit completion rates, and outcome assessment completion rates.
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up to 2 years
|
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acceptability of intervention participation
Periodo de tiempo: 3 months (+/- 3 weeks) from patient enrollment
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We will report the percentage of patients and caregivers who found the intervention acceptable.
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3 months (+/- 3 weeks) from patient enrollment
|
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intervention fidelity
Periodo de tiempo: Up to 2 years
|
We will use post-visit checklists to characterize the number and types of recommended topics covered during each supportive care intervention visit.
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Up to 2 years
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perceived effectiveness
Periodo de tiempo: 3 months (+/- 3 weeks) from patient enrollment
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We will report the percentage of patients and caregivers who perceived the intervention to be effective for treating symptoms, understanding their illness, coping, and planning for the future.
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3 months (+/- 3 weeks) from patient enrollment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
change in patient quality of life
Periodo de tiempo: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of change in patient quality of life from baseline to 3 months using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep).
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
|
patient healthcare utilization
Periodo de tiempo: up to 2 years
|
We will summarize range and distribution of the following patient healthcare utilization outcomes: number and types of chemotherapy regimens, frequency and timing of chemotherapy regimens, number and length (days) of hospital admissions, number and length (days) of ICU admissions, number of emergency department visits, frequency and timing (days before death) of hospice use, place of death.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
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up to 2 years
|
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patient quality of life
Periodo de tiempo: 3 months (+/- 3 weeks) from patient enrollment
|
We will summarize range and distribution of patient quality of life at 3 months using the FACT-Hep scale.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
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3 months (+/- 3 weeks) from patient enrollment
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
patient illness understanding and care preferences
Periodo de tiempo: 3 months (+/- 3 weeks) from patient enrollment
|
We will assess range and distribution of patient illness understanding using validated questions about patients' perceptions of curability, life expectancy, acknowledgement of whether or not s/he has a terminal illness, and preferences for comfort-oriented vs life-prolonging treatment.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
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3 months (+/- 3 weeks) from patient enrollment
|
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change in patient anxiety symptoms
Periodo de tiempo: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will assess change in patient anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS) administered at baseline and 3 months.
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
|
change in patient distress
Periodo de tiempo: baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of change in patient distress responses from baseline to 3 months, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool, where patients rate their distress on a visual guide from 0, 'no distress' to 10, 'extreme distress.'
Scores will be compiled to assess range and distribution at 3-months.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
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baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment
|
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change in patient depressive symptoms
Periodo de tiempo: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will assess change in patient depression from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9).
HADS and PHQ-9 depression scores will be compiled to assess range and distribution at baseline and 3 months.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
|
change in caregiver distress
Periodo de tiempo: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of change in caregiver distress responses from baseline to 3 months, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
|
change in caregiver burden
Periodo de tiempo: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will summarize the range and distribution of the reported change in caregiving burden from baseline to 3 months, collected with the Zarit Burden Interview and Family Member Concerns scale.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
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baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
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caregiver grief
Periodo de tiempo: 1-3 months after death of enrolled patient
|
We will assess caregiver grief after the death of their loved one (enrolled patient), if the patient dies during study participation and up to 2-year follow up.
We will use the Inventory of Complicated Grief to assess how much and how often caregivers are affected by the loss of their loved one and summarize the range and distribution of this data.
Because this is a pilot study, we will not conduct formal tests of efficacy.
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1-3 months after death of enrolled patient
|
|
change in caregiver anxiety symptoms
Periodo de tiempo: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will assess change in caregiver anxiety symptoms from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS).
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
|
change in caregiver depressive symptoms
Periodo de tiempo: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will assess change in caregiver depressive symptoms from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS).
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
|
caregiver perceptions of circumstances surrounding death and preparedness for death
Periodo de tiempo: 1-3 months after death of enrolled patient
|
We will assess caregiver perceptions of circumstances surrounding death and preparedness for death using four previously validated questions.
We will summarize range and distribution of responses.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
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1-3 months after death of enrolled patient
|
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quality of life of seriously ill patients
Periodo de tiempo: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of patient quality of life using the Quality of Life - Seriously Ill Patients (QUAL-E) score.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
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patient emotional acceptance of illness
Periodo de tiempo: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of patient emotional acceptance of illness using the PEACE Scale.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
|
patient anxiety
Periodo de tiempo: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of patient anxiety using the Hospital Anxiety and Depression Scale (HADS).
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
|
patient distress
Periodo de tiempo: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution in patient distress responses, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool, where patients rate their distress on a visual guide from 0, 'no distress' to 10, 'extreme distress.'
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
|
patient depression
Periodo de tiempo: 3 months (+/- 3 weeks) after enrollment
|
We will assess patient depression from with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9).
HADS and PHQ-9 depression scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
|
caregiver distress
Periodo de tiempo: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution in caregiver distress responses, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
|
caregiver burden
Periodo de tiempo: 3 months (+/- 3 weeks) after enrollment
|
We will summarize the range and distribution of the reported caregiving burden, collected with the Zarit Burden Interview and Family Member Concerns scale.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
|
caregiver anxiety symptoms
Periodo de tiempo: 3 months (+/- 3 weeks) after enrollment
|
We will assess caregiver anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS).
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
|
caregiver depressive symptoms
Periodo de tiempo: 3 months (+/- 3 weeks) after enrollment
|
We will assess caregiver depressive symptoms with the Hospital Anxiety and Depression Scale (HADS).
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Yael Schenker, MD, MAS, University of Pittsburgh
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
1 de julio de 2013
Finalización primaria (Actual)
1 de agosto de 2015
Finalización del estudio (Actual)
1 de agosto de 2015
Fechas de registro del estudio
Enviado por primera vez
7 de junio de 2013
Primero enviado que cumplió con los criterios de control de calidad
24 de junio de 2013
Publicado por primera vez (Estimar)
25 de junio de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de mayo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
10 de mayo de 2016
Última verificación
1 de mayo de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PRO13020507
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. .