- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07675083
Bereaved Parent Conversations on Hope
Bereaved Parent Conversations on Hope (BeHope)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Primary Objectives
Aim 1: To assess feasibility and acceptability of virtual conversations about hope between bereaved parent advisors and learners at St. Jude Children's Research Hospital.
Aim 2: To evaluate impact of discussions about hope on both bereaved parent advisors and learners.
Secondary Objectives
Aim 1: To explore impact of discussion with bereaved parent advisors and subsequent reflection on participant professional identity formation.
This intervention is designed to facilitate direct conversations between learners and bereaved parent advisors about how hope evolves through the child's cancer journey. Providing a structured, virtual opportunity to discuss hope will allow learners to hear about the lived experiences of bereaved parents as they navigated pediatric cancer treatment, end of life, and bereavement. The intervention incorporates a discussion guide to support the conversation and a post-session reflection exercise. Assessments will include quantitative surveys administered pre-intervention and immediately post-intervention, as well as qualitative written reflections from participants and bereaved parents.
Both participant groups will receive an information sheet detailing the study's purpose, procedures, potential risks, and benefits. An affirmative response on the pre-intervention survey to the item, "I would like to participate in a virtual educational discussion about hope," will be considered as implied consent to participate in the educational intervention portion of the study for both participants and facilitators. Investigators plan to enroll a total of 50 learners and 25 bereaved parent advisors.
For each learner who agrees to participate, two bereaved parent advisors will be identified and scheduled to meet virtually with the learner for approximately 1 hour using a virtual platform. Prior to the meeting, bereaved parent advisors will be instructed to select 3 photos that represent how hope evolved during their child's illness journey. Both the learners and bereaved parent advisors will be provided with the discussion guide for review prior to the session. Each virtual meeting will be recorded for implementation fidelity and for reference should any learner or parent concerns arise retrospectively from the conversation.
Immediately following each virtual meeting, both the learners and bereaved parent advisors will be asked to engage in individual short (15 minute) written reflections. Following this, participants will complete additional post-intervention survey questions with data collection managed through an online software platform. A second meeting with the same parents may be held at the learners request and the parents willingness. The participants who agree to and participate in a second meeting will receive open-ended questions and be prompted to complete a timed written reflection after the second meeting.
On an approximately quarterly basis, learners who have previously completed the intervention will be invited to participate in a facilitated group debrief and reflection session. Separately, bereaved parent advisors who have participated in at least one virtual meeting in the preceding quarter will be invited to a discussion and feedback session to share about their experiences with the program. For parents who do not prefer a group meeting, an individual session will be offered. All debriefing sessions will be recorded.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Brittany Cowfer, MD
- Número de teléfono: 888-226-4343
- Correo electrónico: referralinfo@stjude.org
Ubicaciones de estudio
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38105
- St. Jude Children's Research Hospital
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Investigador principal:
- Brittany Cowfer, MD
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Contacto:
- Brittany Cowfer, MD
- Número de teléfono: 888-226-4343
- Correo electrónico: referralinfo@stjude.org
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria
Intervention Participants must be:
- Students, observers, trainees, and newly hired clinicians,
- ≥18 years old,
- participating in or observing clinical care at St. Jude Children's Research Hospital, and
- willing to participate in the virtual intervention and associated study activities as learners
Intervention Facilitators must be:
- Bereaved parents,
- ≥ 18 years old,
- screened and cleared to volunteer as advisers with St. Jude Children's Research Hospital through Family, Guest and Volunteer Services, and
- willing to participate in the virtual intervention and associated study activities as a facilitator
Exclusion Criteria
Intervention Participants:
- Age < 18 years, decline participation, or unable to speak/write in conversational English.
Intervention Facilitators:
- Age < 18 years, decline participation, or unable to speak/write in conversational English.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- 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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Otro: Educational Intervention
Intervention Participants: Students, observers, trainees, and newly hired clinicians ≥18 years old participating in or observing clinical care at St. Jude Children's Research Hospital, and willing to participate in the virtual intervention and associated study activities as learners. Intervention Facilitators: Bereaved parents ≥ 18 years old screened and cleared to volunteer as advisers with St. Jude Children's Research Hospital and willing to participate in the virtual intervention and associated study activities as a facilitator. |
See Detailed Description
See Detailed Description
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of Intervention and Acceptability of Intervention Measures
Periodo de tiempo: Day 1 after virtual meeting
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Feasibility will be evaluated using the Feasibility of Intervention Measure (FIM), which includes four itemized responses that are scored from one to five, such that one represents the lowest possible mean score and five the highest possible mean score.
Acceptability will be evaluated using the Acceptability of Intervention Measure (AIM), which includes four itemized responses that are scored from one to five, such that one represents the lowest possible mean score and five the highest possible mean score.
Feasibility and acceptability will be evaluated for the overall study cohort, including both learners and bereaved parent advisors, and by subgroup.
Feasibility and Acceptability are standardly considered to be achieved with a mean score ≥3 for each.
Higher scores indicate greater perceived feasibility and acceptability.
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Day 1 after virtual meeting
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Survey
Periodo de tiempo: At enrollment and day 1 after virtual meeting
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To evaluate the impact of discussions about hope on both bereaved parent advisors and learners, investigators will summarize the distribution of responses to the pre and post intervention survey items by reporting frequencies and percentages for each response category.
Pre-intervention surveys will also contain demographic information.
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At enrollment and day 1 after virtual meeting
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Written Reflections
Periodo de tiempo: Day 1 after virtual meeting
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Written reflections, captured after each virtual session, will be de-identified and analyzed using content analysis, an inductive approach which may include memo-writing, codebook development, coding, reconciliation, and synthesis to identify patterns and themes that emerge from the reflections.
These will be used to assess impact of the session on both learners and parent advisors.
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Day 1 after virtual meeting
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Debrief Sessions
Periodo de tiempo: Quarterly over 2 years
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Quarterly debrief sessions will be offered to those who have completed the intervention separately for bereaved parent advisors and learners.
Learner debriefing sessions will be recorded, transcribed, and analyzed qualitatively to assess for impact on professional identity formation.
Optional parent advisor debriefs will also be recorded and analyzed to further assess impact on facilitators.
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Quarterly over 2 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Brittany Cowfer, MD, St. Jude Children's Research Hospital
Publicaciones y enlaces útiles
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
Otros números de identificación del estudio
- BeHope
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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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