Pilot Testing ACCOMPANI: A Nurse-Targeted Intervention to Promote Psychosocial Equity in Pediatric Oncology (ACCOMPANI)
Pilot Testing ACCOMPANI: A Nurse?Targeted Intervention to Promote Psychosocial Equity in Pediatric Oncology
This study is evaluating ACCOMPANI, a nurse-targeted intervention intended to promote psychosocial equity in pediatric oncology nurses and stakeholders.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This protocol, titled "Pilot Testing ACCOMPANI: A Nurse-Targeted Intervention to Promote Psychosocial Equity in Pediatric Oncology," includes multiple study aims. For qualitative aims, participants will be recruited from the relevant pediatric oncology nurse population, and activities may include focus groups, stakeholder sessions, and semi-structured interviews conducted remotely or in approved private settings.
For the pilot intervention aim, nurse participants will attend four study visits, with sessions planned at approximately 30 minutes weekly. Participants will be randomized in waves until the target of 20 participants per group is reached for the intervention and usual care groups. Each intervention group will include 5 to 10 participants, and sessions will be offered on a rolling basis approximately 1 to 2 weeks apart depending on enrollment and study team availability.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ijeoma Eche-Ugwu, MD
- Número de teléfono: 857-215-1248
- Correo electrónico: ijeomaj_eche@dfci.harvard.edu
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Pediatric oncology nurses who work at Dana-Farber Cancer Institute or Boston Children's Hospital in a:
- Full time OR Part time
- Provide direct care to children with cancer and their families
- Inpatient OR outpatient setting
- Age 18 years and older
Exclusion Criteria:
-
Nurses will be excluded if they are:
- In orientation OR
- no longer working as a bedside pediatric oncology nurse
Plan de estudios
¿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 |
Intervención / Tratamiento |
|---|---|
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Experimental: ACCOMPANI Intervention
Nurse participants receive the ACCOMPANI intervention through four study visits. Sessions are planned to be about 30 minutes weekly, delivered in groups of 5-10 participants, with rolling scheduling based on enrollment and staff availability. Sessions occur in private areas within the DFCI/BCH campus. Participants are reminded of consent elements at the beginning of each session. |
Nurse participants receive the ACCOMPANI intervention through four study visits. Sessions are planned to be about 30 minutes weekly, delivered in groups of 5-10 participants, with rolling scheduling based on enrollment and staff availability. Sessions occur in private areas within the DFCI/BCH campus. Participants are reminded of consent elements at the beginning of each session. |
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Comparador activo: Usual Care
Participants in the comparator group are assigned to usual care. |
Participants in the comparator group are assigned to usual care. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Enrollment Rate
Periodo de tiempo: 6 months
|
Enrollment rate is defined as the proportion of approached nurses who enroll in the pilot randomized controlled trial. |
6 months
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Intervention completion rate
Periodo de tiempo: Up to 5 weeks
|
Completion will be defined as the proportion of enrolled participants who complete the post-intervention follow-up survey assessment. |
Up to 5 weeks
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Acceptability of Intervention (AIM) Rate
Periodo de tiempo: At post-intervention follow-up (T2), approximately 5 weeks after baseline.
|
The AIM assessment has 4 items scored on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). A higher score is greater perceived acceptability. An overall score for each participant is calculated as the mean of the responses to the 4 items. The AIM rate is the proportion of particpants who have an overall mean score of 4 or higher. |
At post-intervention follow-up (T2), approximately 5 weeks after baseline.
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Appropriateness of Intervention (IAM) Rate
Periodo de tiempo: At post-intervention follow-up (T2), approximately 5 weeks after baseline.
|
The IAM assessment has 4 items scored on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). A higher score is greater perceived appropriateness. An overall score for each participant is calculated as the mean of the responses to the 4 items. The IAM rate is the proportion of particpants who have an overall mean score of 4 or higher. |
At post-intervention follow-up (T2), approximately 5 weeks after baseline.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in New General Self-Efficacy Scale (NGSE) score from Baseline to Post-Intervention Follow-Up
Periodo de tiempo: At baseline and post-intervention follow-up (T2), up to approximately 5 weeks
|
The NGSE assessment has 8 items scored on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). A higher score is greater self-efficacy. An overall score for each participant is calculated as the mean of the responses to the 8 items. The change in NGSE score is the NGSE score at post-intervention follow-up less the NGSE score at baseline. |
At baseline and post-intervention follow-up (T2), up to approximately 5 weeks
|
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Change in Inventory for Assessing the Process of Cultural Competence Among Healthcare Professionals-Revised (IAPCC-R) score from Baseline to Post-Intervention Follow-Up
Periodo de tiempo: At baseline and post-intervention follow-up (T2), up to approximately 5 weeks
|
The IAPCC-R assessment has 25 items scored on a 4-point scale (1 = strongly agree to 4 = strongly disagree). A higher score is greater self-efficacy. An overall score for each participant is calculated with a range of 25-100. The change in IAPCC-R score is the IAPCC-R score at post-intervention follow-up less the IAPCC-R score at baseline. |
At baseline and post-intervention follow-up (T2), up to approximately 5 weeks
|
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Duration of Contact with Components of the Intervention
Periodo de tiempo: Weekly up to 4 weeks
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The duration of contact with components of the intervention is measured in minutes for each week and summed across all 4 sessions. |
Weekly up to 4 weeks
|
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Number of Components Accessed
Periodo de tiempo: Weekly up to 4 weeks
|
The number of components accessed is counted for each week and summed across all 4 sessions. |
Weekly up to 4 weeks
|
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Number of Modules Completed
Periodo de tiempo: Weekly up to 4 weeks
|
The number of modules completed is counted for each week and summed across all 4 sessions. |
Weekly up to 4 weeks
|
|
Number of Access Attempts
Periodo de tiempo: Weekly up to 4 weeks
|
The number of access attempts is counted for each week and summed across all 4 sessions. |
Weekly up to 4 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ijeoma Eche-Ugwu, MD, Dana-Farber Cancer Institute
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-474
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Marco de tiempo para compartir IPD
Data can be shared no earlier than 1 year following the date of publication
Criterios de acceso compartido de IPD
Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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