Yoga Intervention in Supporting Children With Cancer and Their Parents During Chemotherapy Infusion
22 de julio de 2020 actualizado por: Sheila Ridner, Vanderbilt-Ingram Cancer Center
A Preliminary Pilot Study to Tailor and Evaluate the Feasibility of Child and Parent Yoga (CAPY) During Chemotherapy Infusion
This trial studies how well Yoga works in supporting children with cancer and their parents during chemotherapy infusion.
Pediatric cancer and its treatment is one of life's most stressful events for children and their parents.
Yoga is an ancient holistic healing science that incorporates postures, breathing, relaxation, and meditation to facilitate harmony between body, mind, and spirit.
Participating in Yoga exercise may improve the negative psychosocial effects in children with cancer and their parents during chemotherapy treatment.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
- To determine the feasibility of Yoga for children with cancer and their parents, specifically
- Identify possible required modifications for safe and feasible practice during infusions.
- Obtain recruitment estimates and determine barriers.
- Assess satisfaction.
SECONDARY OBJECTIVES:
- To determine the feasibility of administering and acceptability of measures to assess preliminary efficacy of Yoga for the following outcomes:
- Child psychological distress (stress, anxiety).
- Parent psychological distress (stress, anxiety, anger, depression).
- Child and parent physiological stress (heart rate, respiratory rate, and blood pressure).
- Parent-child communication.
- Child physical symptoms.
OUTLINE:
Patients and parents participate in up to 8 Yoga sessions consisting of check in, awareness, breathing practices, gentle movement, and relaxation over 30 minutes each.
Tipo de estudio
Intervencionista
Inscripción (Actual)
10
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
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University School of Nursing
-
-
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
8 años a 17 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Children: 8-17 years of age, within 4 weeks of: 1) any new cancer diagnosis or newly diagnosed relapsed cancer, and 2) medical clearance who anticipate 3-weeks of continous contact with Monroe Carell Jr. Children's Hospital.
- Parents: 18 years of age and older, child's primary caregiver (planning to attend appointments, infusions visits, or be in hospital rooms/clinics) or secondary caregiver (an as needed back-up to primary).
Children and Parents: able to speak and understand English, absence of cognitive impairment, and willing to engage in Yoga as part of a dyad.
Exclusion Criteria:
- CHILDREN: Medical conditions that would prohibit the safe implementation of a Yoga practice
- PARENTS: Practices Yoga weekly
- PARENTS: Pregnant or plans to become pregnant during next 3 months
- CHILDREN AND PARENTS: Unwilling to work as a dyad.
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Terapia de yoga
|
Estudios complementarios
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Modifications
Periodo de tiempo: Up to 2 years
|
Will be assessed qualitatively.
A tally of the specific modifications will be maintained to determine if particular modification are made more frequently than others.
|
Up to 2 years
|
|
Recruitment
Periodo de tiempo: Up to 2 years
|
The total number of eligible child-parent dyads approached to achieve an enrolled sample of 5 dyads will be tallied.
|
Up to 2 years
|
|
Retention
Periodo de tiempo: Up to 2 years
|
The number of the enrolled child-parent dyads who complete both the self-report assessments required at baseline (T1 - prior to first Yoga session), the Yoga protocol, and the measures at the end-of-infusion (T2 - prior to last Yoga session) will be tallied.
The proportion completing will be used to inform the level of over-recruitment required in future studies of efficacy.
|
Up to 2 years
|
|
Barriers
Periodo de tiempo: Up to 2 years
|
Participants who do not complete the study will be contacted and queried as to the reason for the lack of completion.
A tally of the specific barriers will be maintained to determine if particular barriers are encountered more frequently than others.
This information will inform possible modifications required to the protocol in future research.
|
Up to 2 years
|
|
Participant satisfaction
Periodo de tiempo: Up to 2 years
|
The total number of responses to the 14 satisfaction questions with a rating > 4 (maximum rating = 7) will be generated for each of the 5 parent participants.
It is expected that all participants will exceed that threshold for all questions.
If not, frequency distributions will be used to summarize the responses to each of the 14 items to assess which produced the lower ratings.
Responses to open-ended questions will be analyzed qualitatively.
Findings from both components of the satisfaction survey (program satisfaction and yoga survey) will be used to revise the Yoga protocol as needed.
|
Up to 2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Child psychological distress
Periodo de tiempo: Up to 2 years
|
Will assess child distress using Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Psychological Stress Experiences- Short Form
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Up to 2 years
|
|
Parent psychological distress
Periodo de tiempo: Up to 2 years
|
Will assess parent distress using the PROMIS Depression - Short Form
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Up to 2 years
|
|
Parent psychological distress
Periodo de tiempo: Up to 2 years
|
Will assess parent distress using the PROMIS Emotional Distress - Anger - Short Form
|
Up to 2 years
|
|
Parent psychological distress
Periodo de tiempo: Up to 2 years
|
Will assess parent distress using the PROMIS Anxiety
|
Up to 2 years
|
|
Child and parent physiological stress
Periodo de tiempo: Up to 2 years
|
Will assess blood pressure
|
Up to 2 years
|
|
Child and parent physiological stress
Periodo de tiempo: Up to 2 years
|
Will assess heart rate
|
Up to 2 years
|
|
Child and parent physiological stress
Periodo de tiempo: Up to 2 years
|
Will assess respiratory rate
|
Up to 2 years
|
|
Parent-child communication
Periodo de tiempo: Up to 2 years
|
Will be assessed using the Parent-Adolescent Communication Scale (PACS).
Participants answer 20-40 questions.
A total score is calculated ranging from 20-100 with higher scores indicating more positive communication.
|
Up to 2 years
|
|
Child physical symptoms
Periodo de tiempo: Up to 2 years
|
Will be assessed using the PROMIS Pediatric Physical Stress Experiences -Short Form.
|
Up to 2 years
|
|
Parent psychological distress
Periodo de tiempo: Up to 2 years
|
Parent distress will be assessed using the NIH Toolbox Perceived Stress
|
Up to 2 years
|
|
Child psychological distress
Periodo de tiempo: Up to 2 years
|
Child distress will be assessed using the PROMIS Pediatric Anxiety - Short Form
|
Up to 2 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Terrah Akard, PhD, Vanderbilt University School of Nursing
- Investigador principal: Sheila Ridner, PhD, Vanderbilt University School of Nursing
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)
7 de agosto de 2019
Finalización primaria (Actual)
29 de junio de 2020
Finalización del estudio (Actual)
30 de junio de 2020
Fechas de registro del estudio
Enviado por primera vez
17 de julio de 2019
Primero enviado que cumplió con los criterios de control de calidad
25 de julio de 2019
Publicado por primera vez (Actual)
26 de julio de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de julio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
22 de julio de 2020
Última verificación
1 de julio de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- VICC SUPP 1935
- NCI-2019-04525 (Identificador de registro: NCI, Clinical Trials Reporting Program)
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
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