Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services (PRACXIS)
21 de octubre de 2021 actualizado por: University of California, San Francisco
Non-pharmacologic Approaches to Relieve Pain and Symptom Distress Among Diverse Hospitalized Cancer Patients
Despite improved assessment and pharmacologic management, cancer pain is still undertreated.
Using non-pharmacologic treatments alongside medications may better address patients' total pain experience by relieving physical and psychological symptoms and reducing the adverse effects of drugs.
However, our knowledge of the benefits of multidisciplinary approaches in real-world hospital settings is limited.
Patients want to know "How can I get the most pain relief with the fewest side effects?"
This study proposal is designed to address this question by testing how combining pharmacologic and non-pharmacologic (acupuncture and pain counseling) treatments can: (1) maximize effectiveness, (2) minimize harms, and (3) align with patients' preferences.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study compares clinically-relevant therapeutic options in two high-volume hospitals (one public, one university) to address the core research question of whether non-pharmacologic approaches improve symptom management among diverse inpatients. Study investigators will assess the effectiveness of acupuncture and of pain counseling independently and in combination.
Participants will be randomized to two factors each with two levels, yielding four experimental conditions: (1) standard pharmacologic pain management, (2) pharmacologic pain management + acupuncture, (3) pharmacologic pain management + pain counseling, (4) pharmacologic pain management + acupuncture + pain counseling. Patient outcomes will be assessed using a mixed-methods approach, with validated scales for quantitative measures and qualitative interviews to elicit stakeholder perspectives (patients, caregivers, providers).
The study will be conducted as a pragmatic clinical trial at two hospitals to address these aims:
- Determine the effectiveness of adjunctive acupuncture and of pain counseling for improving pain management.
- Determine the extent that adjunctive acupuncture and pain counseling reduce use of opioid analgesics and side effects.
- Examine stakeholder perspectives on non-pharmacologic approaches to pain management.
Tipo de estudio
Intervencionista
Inscripción (Actual)
448
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
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California
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San Francisco, California, Estados Unidos, 94143
- University of California, San Francisco
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San Francisco, California, Estados Unidos, 94110
- Zuckerberg San Francisco General Hospital
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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
21 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients admitted to University of California San Francisco (UCSF) or Zuckerberg San Francisco General (ZSFG) with a malignant solid tumor
- Speak Cantonese, English, or Spanish
- Have an anticipated stay of ≥ 48 hours
- Be aged 21 or older
- Have pain intensity of ≥ 4 out of 10 for worst pain in the prior 24 hours when enrolled
Exclusion Criteria:
- Acupuncture contraindication
- Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction)
- Admission to the psychiatric ward (e.g., for severe depression)
- Inability to consent (e.g., cognitive impairment)
- Prior involvement with the study (e.g., readmissions)
- Platelets < 50,000 microliters
- Absolute neutrophil count < 500 microliters
- C. difficile infection
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 factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Treatment As Usual
Participants will receive routine care consisting of usual analgesic medications for pain in adults with cancer.
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Comparador activo: Acupuncture
Along with routine pain medications, participants will be offered daily acupuncture treatments for up to four days.
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A licensed acupuncturist will assess participants' symptoms and administer acupuncture needles in accordance with traditional Chinese medicine principles and the study protocol.
Treatments will provided daily for up to four hospital days.
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Comparador activo: Pain Counseling
Along with routine pain medications, participants will receive evidence-based psychosocial support through education and counseling provided by qualified study staff.
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Participants will receive sessions with a counselor trained in pain management.
The pain counselor will explain, review, and discuss the contents of a Pain Control booklet.
Sessions will include pain assessment, pain education, and coping skills, provided daily for up to four hospital days.
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Comparador activo: Acupuncture and Pain Counseling
Along with routine pain medications, participants will be offered daily acupuncture treatments and pain counseling for up to four days as described above.
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A licensed acupuncturist will assess participants' symptoms and administer acupuncture needles in accordance with traditional Chinese medicine principles and the study protocol.
Treatments will provided daily for up to four hospital days.
Participants will receive sessions with a counselor trained in pain management.
The pain counselor will explain, review, and discuss the contents of a Pain Control booklet.
Sessions will include pain assessment, pain education, and coping skills, provided daily for up to four hospital days.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in worst pain intensity assessed by the NRS
Periodo de tiempo: Daily for up to four hospital days
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Participants' worst level of pain in the past 24 hours on a 0-10 numeric rating scale (NRS), 0= no pain and 10= worst pain imaginable
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Daily for up to four hospital days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Use of opioids during hospital stay
Periodo de tiempo: Hospital stay (average length of stay = 5 days)
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Total and average daily use of opioids based on morphine milligram equivalence
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Hospital stay (average length of stay = 5 days)
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Presence and severity of common side effects
Periodo de tiempo: Daily for up to four hospital days
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Nausea, vomiting, agitation, and sedation
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Daily for up to four hospital days
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Cancer-related distress
Periodo de tiempo: Daily for up to four hospital days
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Single item measure developed by the National Comprehensive Cancer Network.
Participants are asked to indicate the number that best describes how much distress they are experiencing in the past week including today, 0=no distress and 10=extreme distress.
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Daily for up to four hospital days
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Health-related quality of life assessed by the EuroQol EQ-5D-3L (EQ-5D-3L)
Periodo de tiempo: Daily for up to four hospital days
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The EuroQol EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 3 levels: no problems, some problems, extreme problems.
The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.
The EuroQol visual analogue scale (EQ VAS) records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
Detailed scoring instructions are available: https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-3L_UserGuide_2015.pdf
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Daily for up to four hospital days
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Treatment Satisfaction Scale
Periodo de tiempo: Assessed once at the end of hospital stay (average length of stay = 5 days)
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The Pain Treatment Satisfaction Scale includes subscales of satisfaction with information, medical care, effectiveness, and side effects with reliability ranging from 0.83 to 0.92.
Each of the subscales are scored from 0 to 100 with higher scores indicating greater satisfaction.
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Assessed once at the end of hospital stay (average length of stay = 5 days)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maria T Chao, DrPH, MPA, University of California, San Francisco
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)
17 de enero de 2019
Finalización primaria (Actual)
30 de septiembre de 2021
Finalización del estudio (Actual)
30 de septiembre de 2021
Fechas de registro del estudio
Enviado por primera vez
30 de agosto de 2018
Primero enviado que cumplió con los criterios de control de calidad
3 de abril de 2019
Publicado por primera vez (Actual)
5 de abril de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de octubre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
21 de octubre de 2021
Última verificación
1 de octubre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 17-23446
- NCI-2018-02204 (Identificador de registro: NCI Clinical Trials Reporting Program (CTRP))
- 18801 (University of California, San Francisco)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
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
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. .