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Integrating Supportive Care in Cystic Fibrosis

17 de febrero de 2020 actualizado por: Dio Kavalieratos, PhD, University of Pittsburgh

Integrating Supportive Care in Cystic Fibrosis: A Pilot Study

Individuals living with cystic fibrosis (CF) commonly report high symptom burden, poor quality of life, and additional psychosocial stressors; these burdens are particularly heightened in advanced stages of the disease. Although supportive care (aka palliative care) has been shown to improve many of these outcomes among patients with illnesses such as cancer, no clinical trials to date have tested the impact of supportive care for patients with CF. The purpose of this pilot randomized clinical trial study is to evaluate the feasibility, acceptability, and perceived effectiveness of an embedded supportive care intervention, whereby a supportive care specialist will be integrated within the usual care experience of patients with advanced CF. The investigators will enroll 50 patients with advanced CF, who will be equally randomized to receive this embedded supportive care intervention or usual care. Secondary measures include: patient quality of life, mood, coping style, satisfaction with care, and symptom burden. This study will provide preliminary data to support the development of a larger, definitive, Phase III randomized clinical trial.

Descripción general del estudio

Estado

Terminado

Condiciones

Fibrosis quística

Intervención / Tratamiento

Conductual: Supportive Care Intervention

Descripción detallada

As described above.

Tipo de estudio

Intervencionista

Inscripción (Actual)

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

Estados Unidos
- Pennsylvania
  - Pittsburgh, Pennsylvania, Estados Unidos, 15213
    - University of Pittsburgh

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

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Ability to comprehend English
Advanced CF

(Any of the following criteria will be indicative of "Advanced CF")

Baseline supplemental oxygen requirement
FEV1 ≤ 50%
Baseline non-invasive mechanical ventilation requirement
≥ 2 hospitalizations in the past 12 months for respiratory complications related to CF

Exclusion Criteria:

Prisoners
Females who are pregnant
Prior receipt of specialist SC services
Cognitive impairments
Patients younger than 18 years of age

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 Grupo de participantes/brazo Un grupo o subgrupo de participantes en un ensayo clínico que recibe una intervención/tratamiento específico, o ninguna intervención, según el protocolo del ensayo.	Intervención / Tratamiento Intervención / Tratamiento Un proceso o acción que es el foco de un estudio clínico. Las intervenciones incluyen medicamentos, dispositivos médicos, procedimientos, vacunas y otros productos que están en fase de investigación o que ya están disponibles. Las intervenciones también pueden incluir enfoques no invasivos, como la educación o la modificación de la dieta y el ejercicio.
Sin intervención: Usual Care Patients randomized to the control arm of this study will continue to receive the standard of high-quality CF care provided to all patients at the UPMC CF Center.
Experimental: Supportive Care Intervention Patients randomized to the intervention arm will receive a protocolized supportive care intervention from a palliative care nurse practitioner.	Conductual: Supportive Care Intervention Patients in the intervention arm of the study will see a SC specialist during regularly-scheduled CF clinic visits; per usual care, these visits should occur on a quarterly basis. Using a structured intervention manual, these visits will span 30-60 minutes each. Each visit will have a specific focus, such as: 1) comprehensive palliative care assessment; 2) symptom assessment and self-management; 3) advance care planning; and, 4) coping and resilience. Patients requiring follow up with SC before the next CF appointment will receive telephone follow up or an extra SC visit at the discretion of the SC provider.

Grupo de participantes/brazo

Intervención / Tratamiento

Sin intervención: Usual Care

Patients randomized to the control arm of this study will continue to receive the standard of high-quality CF care provided to all patients at the UPMC CF Center.

Experimental: Supportive Care Intervention

Patients randomized to the intervention arm will receive a protocolized supportive care intervention from a palliative care nurse practitioner.

Conductual: Supportive Care Intervention

Patients in the intervention arm of the study will see a SC specialist during regularly-scheduled CF clinic visits; per usual care, these visits should occur on a quarterly basis. Using a structured intervention manual, these visits will span 30-60 minutes each. Each visit will have a specific focus, such as: 1) comprehensive palliative care assessment; 2) symptom assessment and self-management; 3) advance care planning; and, 4) coping and resilience. Patients requiring follow up with SC before the next CF appointment will receive telephone follow up or an extra SC visit at the discretion of the SC provider.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Feasibility of intervention Periodo de tiempo: Up to 9 months (+/- 4 weeks)	Measured by: eligibility rate, approach-to-consent rate, approach-to-enroll rate, rate of missed intervention sessions, rate of missing data on patient-reported outcomes.	Up to 9 months (+/- 4 weeks)
Acceptability of intervention Periodo de tiempo: Up to 9 months (+/- 4 weeks)	Measured by: proportion of participants who endorse the intervention as acceptable.	Up to 9 months (+/- 4 weeks)
Perceived effectiveness of intervention Periodo de tiempo: Up to 9 months (+/- 4 weeks)	Measured by: proportion of participants who endorse that they believe the intervention to have been beneficial.	Up to 9 months (+/- 4 weeks)
Intervention fidelity Periodo de tiempo: Up to 9 months (+/- 4 weeks)	Evaluate the fidelity of intervention delivery using structured visit checklists to be completed by the interventionist and research staff.	Up to 9 months (+/- 4 weeks)

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Patient quality of life: Cystic Fibrosis Questionnaire-Revised (CFQ-R) Periodo de tiempo: Up to 9 months (+/- 4 weeks)	Change in QOL from baseline as measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R) at 9 months. Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.	Up to 9 months (+/- 4 weeks)
Patient mood Periodo de tiempo: Up to 9 months (+/- 4 weeks)	Change in mood from baseline using the Hospital Anxiety and Depression Scale (HADS), reported at 0, 3, 6, 9 months. Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.	Up to 9 months (+/- 4 weeks)
Coping style Periodo de tiempo: Up to 9 months (+/- 4 weeks)	Change in coping style from baseline using the Brief COPE, reported at 0, 3, 6, 9 months. Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.	Up to 9 months (+/- 4 weeks)
Satisfaction with care Periodo de tiempo: Up to 9 months (+/- 4 weeks)	Change in satisfaction with care from baseline using the FAMCARE-P13, reported at 0, 3, 6, 9 months. Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.	Up to 9 months (+/- 4 weeks)
Symptom burden Periodo de tiempo: Up to 9 months (+/- 4 weeks)	Change in symptom burden from baseline using the Edmonton Symptom Assessment Scale (ESAS), reported at 0, 3, 6, 9 months. Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.	Up to 9 months (+/- 4 weeks)

Otras medidas de resultado

Medida de resultado	Medida Descripción	Periodo de tiempo
Healthcare utilization Periodo de tiempo: Up to 12 months	The investigators will evaluate various measures of healthcare utilization, such as: ED visits, unplanned hospitalizations, and healthcare expenditures.	Up to 12 months

Colaboradores e Investigadores

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

Patrocinador

University of Pittsburgh

Colaboradores

Cystic Fibrosis Foundation

Investigadores

Investigador principal: Dio Kavalieratos, PhD, Section of Palliative Care and Medical Ethics; Division of General Internal Medicine, University of Pittsburgh
Investigador principal: Joseph Pilewski, MD, Pulmonary, Allergy, and Critical Care Medicine Division; 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 (Actual)

2 de marzo de 2016

Finalización primaria (Actual)

29 de noviembre de 2018

Finalización del estudio (Actual)

7 de octubre de 2019

Fechas de registro del estudio

Enviado por primera vez

14 de enero de 2016

Primero enviado que cumplió con los criterios de control de calidad

26 de enero de 2016

Publicado por primera vez (Estimar)

29 de enero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de febrero de 2020

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

17 de febrero de 2020

Última verificación

1 de febrero de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Fibrosis quística pulmonar

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

IRB#: PRO14110168

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

It is possible that the investigators may use the information obtained from this study in other research studies examining the treatment of Cystic Fibrosis. This information may also be shared with other researchers here and at other research centers, but those researchers will never be provided with any personal identifiers that would allow them to learn participant's identity.

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. .

Integrating Supportive Care in Cystic Fibrosis