Feasibility and Acceptability of Empowered Relief for American Indians With Pain During and After Cancer Treatment (ejames3)
This project will evaluate the feasibility and acceptability of Empowered Relief (ER) among American Indian adults who are currently receiving or have completed active cancer treatments at Stephenson Cancer Center (SCC). ER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment. Because of its brief, didactic nature and Zoom delivery, ER can accommodate large class sizes and may address accessibility disparities among underserved cancer populations. While ER is being studied across various non-cancer populations and has been adopted as standard of care in leading healthcare institutions in the U.S. and abroad, it has not been tested in American Indians with cancer.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jordan Keast
- Número de teléfono: 405-615-1474
- Correo electrónico: jordan-keast@ou.edu
Ubicaciones de estudio
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74104
- Stephenson Cancer Center - Tulsa Location
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Contacto:
- Sophia You
- Número de teléfono: 918-660-3925
- Correo electrónico: dokyoung-you@ou.edu
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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:
- Identifies as American Indian
- Has history of a cancer diagnosis
- Is currently undergoing or has completed active cancer treatment
- Experiences body pain most or every day
- Pain duration at least 3 months
- English fluency
Exclusion Criteria:
- Significant psychological and cognitive impairment that limits one's ability to complete study tasks (completion of online survey, attending the Zoom-based ER class)
- Life-threatening acute illness (e.g., infection, heart attack, injury)
- No access to a computer, a smartphone, or a tablet
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Empowered Relief
Participants in this arm will complete a 2-hour Empowered Relief pain management course and get access to all the course materials. Participants will complete a series of follow-up surveys assessing the feasibility of the class for their pain intervention. |
ER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of ER in American Indian populations
Periodo de tiempo: From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)
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Indexed by:
Measures will be factored together to make an assessment on total feasibility. |
From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)
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Identify areas for cultural tailoring and improvement of ER
Periodo de tiempo: Assessed as part of the optional (n=30) Qualitative Post-class interview. (approx. 30 minutes)
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We will use qualitative data from interviews to generate actionable recommendations to improve the cultural engagement, acceptability, and relevance of ER for American Indians with cancer. |
Assessed as part of the optional (n=30) Qualitative Post-class interview. (approx. 30 minutes)
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Pain Intensity
Periodo de tiempo: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class
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Pain intensity will be reported on a scale from 1-10, with 1 being "No Pain" and 10 being "Worst Pain Imaginable." |
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class
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Pain Interference
Periodo de tiempo: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Pain interference will be gauged using a series of questions decerning the impact of the participants participants pain on daily activities. Participants will rate the interference on a scale from 1-5, with 1 being "Not at All" and 5 being "Very Much." |
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Emotional Distress
Periodo de tiempo: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Emotional distress will be measured using a series of questionnaires asking participants about the frequency of certain emotional reactions. Participants will report frequency on a scale from 1-5, with 1 being "Never" and 5 being "Always." |
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Sleep Disturbance
Periodo de tiempo: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Sleep Disturbance will be recorded using a series of questions rating the quality and frequency of sleep. Participants will report on quality and frequency on a scale from 1-5, with 1 being "Very Poor/Not at All" and 5 being "Very Good/Very Much." |
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Perceived Quality of Life
Periodo de tiempo: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Perceived Quality of Life will be reported on a scale from 1-5, with 1 being "Poor" and 5 being "Excellent." |
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sophia You, University of Oklahoma
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- 20065Ph1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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