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Preparación para la vida y el ámbito académico para los supervivientes de cáncer infantil (PLAY)

30 de octubre de 2026 actualizado por: Emily Moscato, Nationwide Children's Hospital

Intervención de salud digital para mejorar los resultados del desarrollo neurológico de los sobrevivientes de cáncer infantil en comunidades desatendidas

The goal of this clinical trial is to test and improve an online program for caregivers of young childhood cancer survivors called the Preparing for Life and Academics for Young Survivors program (PLAY). The PLAY program was created with a group of caregivers of young children with cancer and healthcare providers. Ultimately, investigators hope to see if the program can improve positive parenting behaviors, reduce caregiver stress, and help get young children ready for school. In the preliminary phase of this clinical trial, investigators are aiming to answer these questions:

  1. Are caregivers of childhood cancer survivors willing to participate in the PLAY program and complete assessments before and after the program?
  2. Do caregivers of childhood cancer survivors rate the PLAY program as easy to use?
  3. Are caregivers of childhood cancer survivors satisfied with the PLAY program?
  4. How can the PLAY program be improved in the future?
  5. Does PLAY help improve how caregivers interact and read with their children or how they manage their own stress?

When the child is transitioning to maintenance phase therapies or is no longer actively in cancer treatment, caregivers will be invited to participate. If they agree to participate, they will complete surveys when they begin the study as well as a videotaped interaction task reading and playing with their child. Children will complete brief developmental testing at the beginning of the program.

Caregivers will then complete the PLAY Program, which will involve completing 7 weekly or bi-weekly online modules and meeting with a trained coach by videoconference for up to 10 one-hour sessions over three months. Sessions will focus on helping their child get ready for school and helping their family adjust and cope with stress.

Caregivers will repeat the surveys and videotaped interaction task again three months later, after the PLAY program is completed. They will also be invited to participate in an interview to learn about their experience in the program.

This study will happen over two phases. Participants in Phase I of this study will complete all parts of the study as described above. Participants in Phase II (beginning in winter 2025) will complete all parts of the study as described above and a six month follow up that will involve repeating the similar questionnaires and an additional videotaped interaction with their child. Teachers of children will also take part in Phase II with questionnaires at baseline and 3-months later, after participants have completed the PLAY program.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This study will occur in two phases. Phase I will involve rapid cycle testing of the intervention and Phase II will be a single-arm trial of the PLAY program.

For phase I, the aim of this study is to refine PLAY to optimize feasibility and acceptability (ORBIT Phase Ib) through rapid-cycle testing with families of YCCS (n=5 per group, up to 15 total) in partnership with advisory boards comprised of 10 families of YCCS, including rural and Appalachian YCCS, and 10 healthcare providers ("co-designers"). Rapid cycle testing to iteratively refine PLAY will determine its optimal timing, dose, and duration until three caregivers sequentially endorse above-average usability (System Usability Scale score >68), feasibility, and acceptability ratings (>80%), or up to n=15 families have completed the PLAY program.

Following rapid cycle testing, phase II will involve a single-arm trial of PLAY program with up to 20 new families of YCCS to evaluate the refined program's feasibility, acceptability, and proof-of-concept. Caregivers will be recruited and will participate using analogous procedures and measures, as described in Phase I, with the addition of 6-month post-baseline assessments.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

105

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Ohio
      • Columbus, Ohio, Estados Unidos, 43205
        • Reclutamiento
        • Nationwide Children's Hospital
        • Contacto:
        • Investigador principal:
          • Emily Moscato, PhD

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

For the caregiver:

  • Caregiver is the legal guardian of the child (e.g., mothers, fathers, grandparents, adoptive parents)
  • Caregiver lives with the child more than 50% of the time
  • Caregiver primary language is English
  • Caregiver lives within 150 miles of Nationwide Children's Hospital

For the childhood cancer survivor:

  • Received treatment for their cancer (e.g., chemotherapy, surgical resection, radiation therapy)
  • Completed cancer treatment or on maintenance therapy only, without evidence of recurrent disease
  • Childhood cancer survivor is currently between the ages of 3 years old to 6 years old, but no older than 6.5 years old at study enrollment

Exclusion Criteria for the childhood cancer survivor:

  • Has a documented neurodevelopmental disorder prior to their cancer diagnosis (e.g., neurofibromatosis, tuberous sclerosis, Down's syndrome, autism)
  • Did not receive any treatment for their cancer (e.g., chemotherapy, surgical resection, radiation)
  • Treated for a benign tumor

For the teacher:

Classroom or daycare teacher of the childhood cancer survivor

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: Preparing for Life and Academics for Young (PLAY) survivors program

PLAY is a digital health intervention involving 7 self-directed web-modules and up to 10 virtual coaching sessions conducted weekly to biweekly (7 paired plus up to 3 booster sessions) for caregivers of young childhood cancer survivors (3-6 years). The module content focuses on psychoeducation and positive parenting skills and the coaching focuses on live practice of positive parenting skills.

The PLAY Program is a web-based program created for caregivers of childhood cancer survivors. The program consists of seven modules with the following topics: 1) Introduction to the program 2) Self-Care 3) Relationships 4) Getting Ready for School 5) Talking, Reading, and Counting together 6) Social and Emotional Development 7) Review Module. The program is meant to be completed over approximately three months, and caregivers in the program will meet with a coach on a weekly or bi-weekly basis to discuss what they learned in the modules and how to practice it in their daily lives.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
System Usability Scale
Periodo de tiempo: 3 months post-enrollment

This is a 10-item measure that will quantitatively assess usability of our web-based program. The SUS measures how accessible the website is and whether participants can understand the content of the website on a scale of 0-100. We will continue to recruit until our website has achieved an average score of >68% (above average).

3 months post-enrollment
Intervention Appropriateness Measure (IAM)
Periodo de tiempo: 3 Months Post-Enrollment

Participants will use this four-item measure to rate the appropriateness of the PLAY program. Each item is rated from 1-5 and the final score for the measure is the average number for all answers. A higher score means a participant rated the PLAY program as more appropriate, an overall score of 4 or higher (80%) means a participant found the program to be appropriate.

3 Months Post-Enrollment
Acceptability of Intervention Measure (AIM)
Periodo de tiempo: 3 Months Post-Enrollment

This is a four-item measure that will have participants rate the acceptability of the PLAY program. Each item is rated from 1-5 and the final score for the measure is the average number for all answers. A higher score means a participant rated the PLAY program as more acceptable, an overall score of 4 or higher (80%) means a participant found the program to be acceptable.

3 Months Post-Enrollment
Adapted Website Evaluation Questionnaire (WEQ)
Periodo de tiempo: 3 months post-enrollment

This measure will assess accessibility and satisfaction with the PLAY Program. Four overall items will be rated from 1-10 by participants. The overall score will be the average response across items. A higher score indicates higher satisfaction with the program. Overall scores of 8 or higher (> 80%) are an indication of satisfaction with the PLAY program.

3 months post-enrollment
Feasibility of the PLAY program
Periodo de tiempo: 3 month post-enrollment (Phase I); 3 and 6 month post-enrollment (Phase II)

Enrollment rate (#enrolled/#approached; milestone greater than or equal to 50%), completion rate (# completing core PLAY sessions/#enrolled; milestone greater than or equal to 75%), retention rate (#completers of 3 and 6 month assessments/ # enrolled at baseline; milestone greater than or equal to 70%); Caregivers who rate the intervention greater than or equal to 80% on the Feasibility Intervention Measure (FIM; milestone >80%), which is a four-item measure. Each item is rated from 1-5 and the final score for the measure is the average number for all answers. A higher score means a participant rated the PLAY program as more feasible, an overall score of 4 or higher (80%) means a participant found the program to be feasible.

3 month post-enrollment (Phase I); 3 and 6 month post-enrollment (Phase II)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Play and Alternative Learning Strategies parent-child interaction coding
Periodo de tiempo: Baseline, 3 and 6 month follow up (Phase II)

Caregivers will record themselves playing with with their child for at least 10 minutes for a measure of observed positive parenting behaviors which will be rated with the standardized Play and Learning Strategies coding scheme by trained raters blinded to timepoint. The coding scheme involves 1 to 5 Likert scale ratings of positive parenting behaviors (i.e., warmth, contingent responsiveness, maintaining, verbal scaffolding, demonstration/physical teaching). Proof of concept will be determined if 8 of 15 caregivers demonstrate improvements by greater than 1 point on observed positive parenting behaviors from baseline.

Baseline, 3 and 6 month follow up (Phase II)
Parenting Stress Index-Short Form
Periodo de tiempo: Baseline, 3 and 6 months post-enrollment (Phase II)

Caregivers will complete the Parenting Stress Inventory, Short Form (PSI-SF), yielding a Total Parenting Stress Score. Proof-of-concept will be determined if at least 8 of 15 caregivers report either maintenance of non-clinical levels of parenting stress or reduction to non-clinical levels post-intervention (i.e., Total Parenting Stress < 85th percentile).

Baseline, 3 and 6 months post-enrollment (Phase II)
Hospital Depression and Anxiety Scale (HADS)
Periodo de tiempo: Baseline, 3 and 6 months post-enrollment (Phase II)

Caregivers will complete the Hospital Anxiety and Depression Scale (HADS) which yields Anxiety and Depression Total Scores. Proof-of-concept will be determined if at least 8 of 15 caregivers report either maintenance of non-clinical levels of anxiety/depression or reduction to non-clinical levels post-intervention (i.e., HADS scores less than a score of 8).

Baseline, 3 and 6 months post-enrollment (Phase II)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Behavior Rating Inventory of Executive Function (BRIEF-P or -2)
Periodo de tiempo: Baseline, 3 and 6 months post-enrollment (Phase II)

Caregivers and teachers will complete the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P; ages 2 to 5 years) or the BRIEF-2 (ages 5 years+), yielding a General Executive Composite. Proof of concept will be determined if 8 of 15 caregivers and teachers report either that the child has maintained non-clinical levels of executive functioning problems or has reduced executive functioning problems to the non-clinical range post-intervention (i.e., General Executive Composite T-score less than or equal to 65).

Baseline, 3 and 6 months post-enrollment (Phase II)
Adaptive Behavior Assessment System, Third Edition (ABAS-3; Pre-Academics or Functional Academics subscale)
Periodo de tiempo: Baseline, 3 and 6 months post-enrollment (Phase II)

Caregivers and teachers will also complete the Adaptive Behavior Assessment System, Third Edition (ABAS-3; Pre-Academics or Functional Academics subscale). Proof of concept will be determined if 8 of 15 caregivers and teachers either report that the child has maintained on track performance for pre-academic skills, or has improved in their pre-academic skills to a non-delayed range (i.e., scaled score greater than or equal to 6).

Baseline, 3 and 6 months post-enrollment (Phase II)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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)

12 de diciembre de 2024

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

6 de enero de 2025

Primero enviado que cumplió con los criterios de control de calidad

6 de enero de 2025

Publicado por primera vez (Actual)

10 de enero de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • STUDY00004302
  • K08CA290060 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

All collected, deidentified quantitative IPD for the primary and secondary outcomes of the study for participants who consent to have their data shared.

Marco de tiempo para compartir IPD

IPD will be made available after the primary outcomes manuscript is published and will be available for at least seven years post study-closure.

Criterios de acceso compartido de IPD

Interested parties will be able to access the IPD by contacting the PI or through request at the Inter-university Consortium for Political and Social Research.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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