Mejora de la recuperación orientada a la atención plena (MORE) para el alivio del dolor del cáncer
Adaptación de la mejora de la recuperación orientada a la atención plena (MORE) para el alivio del dolor del cáncer: el ensayo MORE Relief
The purpose of this study is to evaluate whether or not mindfulness-based interventions/MBIs may help reduce chronic pain in participants who have cancer-related chronic pain. MBIs are therapeutic programs that use mindfulness meditation practices to help people focus on the present moment, as well as encourage acceptance of thoughts, emotions, and body sensations. The researchers think that an MBI treatment called Mindfulness-oriented Recovery Enhancement (MORE) may help people who are experiencing cancer-related chronic pain.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- English speaking
- Age ≥ 18 years or older
- A history of cancer with no restrictions placed on type of cancer
- Determined to be either no-evidence of disease or stable oncological disease by referring or study physicians/advanced practice providers
- Having a pain (musculoskeletal, generalized, or neuropathic) rating of 4 or greater in worst pain on a 0-10 numerical rating scale in the preceding week
- Having had pain for at least 3 months and at least 15 days with pain in the preceding 30 days
- Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MORE or WLC
- Ability to attend video-call session and a quiet/private location
Exclusion Criteria:
- Active suicidality or schizophrenia
- Plan to initiate palliative radiation or interventional pain procedure within the next 12 weeks
- Cognitive impairment preventing completing PRO independently or participate in virtual MORE as evaluated by study clinicians
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Wait List Control (WLC) Usual Care Procedure
Participants in the WLC group continue to receive their standard medical care and pain management as prescribed by their physicians or other health care providers. |
Participants in the WLC group continue to receive their standard medical care and pain management as prescribed by their physicians or other health care providers. |
|
Experimental: 16-hour MORE treatments
Patients in the 16-hour MORE format will receive one 2hrs treatment a week for 8 consecutive weeks (as per study schema: from week 1 to week 8). |
MORE participants will also be asked to engage in 15 minutes/day of skill practice at home, and complete daily diaries of mindfulness practice time |
|
Experimental: 8-hour MORE treatments
Patients in the 8-hour MORE format will receive one 2hrs treatment a week for 4 consecutive weeks (as per study schema: from week 1 to week 4). |
MORE participants will also be asked to engage in 15 minutes/day of skill practice at home, and complete daily diaries of mindfulness practice time |
|
Experimental: 2-hour MORE treatments
Patients in the 2-hour MORE format will receive one 2hrs treatment (as per study schema: in week 1). |
MORE participants will also be asked to engage in 15 minutes/day of skill practice at home, and complete daily diaries of mindfulness practice time |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rate of participant enrollment to the study
Periodo de tiempo: 12 months
|
Feasibility of the intervention will be determined by Rate of participant enrollment to the study |
12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jun Mao, MD, MSCE, Memorial Sloan Kettering Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- Dolor
- Manifestaciones neurológicas
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor por cáncer
- Dolor crónico
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Terapéutica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Gestión de atención al paciente
- Manejo de enfermedades
- Estándar de cuidado
- Manejo del dolor
Otros números de identificación del estudio
- 23-082
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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