- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07772596
An Artificial Intelligence-Powered Supportive Care Chatbot to Address the Supportive Care Needs of Young Adult Cancer Survivors
13 de agosto de 2026 actualizado por: University of Michigan Rogel Cancer Center
Feasibility, Usability, and Acceptability of an AI-Powered MASCC Supportive Care Platform Among Young Adults With Cancer
This clinical trial studies whether an artificial intelligence (AI)-powered supportive care chatbot is helpful for addressing the supportive care needs of young adult cancer survivors.
Young adult cancer survivors often experience ongoing and distressing symptoms following treatment, including extreme tiredness and lack of energy, anxiety, and difficulty sleeping.
Young adult cancer survivors report a variety of strategies to self-manage these symptoms; however, there remains a gap in targeted interventions focused on the needs in young adult survivors.
The AI-powered supportive care chatbot is designed to provide evidence-based information on supportive care for young adult cancer survivors.
Users interact with the chatbot by entering free-text questions or selecting from predefined topics to receive tailored educational responses related to supportive care across the cancer continuum, including treatment effects, symptom management, care transitions, and life after cancer.
The AI-powered supportive care chatbot may be an effective way to help address the supportive care needs of young adult cancer survivors.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
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
- Nombre: Robert Knoerl
- Número de teléfono: 734-764-8617
- Correo electrónico: rjknoerl@med.umich.edu
Ubicaciones de estudio
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan Rogel Cancer Center
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Contacto:
- Robert Knoerl
- Número de teléfono: 734-764-8617
- Correo electrónico: rjknoerl@med.umich.edu
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Investigador principal:
- Robert Knoerl
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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
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 18 - 39 years old
- Able to speak/read English
- Completed primary cancer treatment (e.g., surgery, radiation, chemotherapy, immunotherapy) at least one month prior to the time of consent. Although, participants will be eligible if they are receiving maintenance treatments
- Report at least one moderate to severe symptom, side effect, or supportive care concern from cancer or its treatment
- Able to access Wi-Fi/internet
- Willing to complete surveys electronically
Exclusion Criteria:
- Completed cancer treatment more than three years ago
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 |
|---|---|
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Experimental: Supportive care (AI-powered supportive care chatbot)
Patients interact with AI-powered supportive care chatbot in a self-directed manner for 4 weeks.
Following the initial 4-week use period, patients choose to either continue to use the chatbot for an additional 8 weeks or conclude study participation.
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Estudios complementarios
Estudios complementarios
Interact with AI-powered supportive care chatbot
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acceptability of AI-powered supportive care chatbot
Periodo de tiempo: At end of intervention, assessed up to 12 weeks
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Acceptability will be supported if mean scores on the Acceptability E-Scale are ≥ 4 (on a 5-point scale).
Will be described (i.e., means, medians, standard deviations, and ranges) at the post-intervention time point.
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At end of intervention, assessed up to 12 weeks
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Demand of AI-powered supportive care chatbot
Periodo de tiempo: Up to 12 months
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Demand will be demonstrated by successful recruitment of the target sample (N=30) within 12 months.
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Up to 12 months
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Implementation of AI-powered supportive care chatbot
Periodo de tiempo: During intervention use, assessed up to 12 weeks
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Implementation will be assessed by engagement with the chatbot, defined as ≥ 70% of participants reporting at least one use per week during the initial 4-week period, rather than a fixed duration of use, given the self-directed nature of the intervention.
Will be described (i.e., means, medians, standard deviations, and ranges) weekly.
Given the pilot nature of the study, no hypothesis testing or formal comparisons will be conducted.
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During intervention use, assessed up to 12 weeks
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Retention
Periodo de tiempo: Up to 12 weeks
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Retention will be considered feasible if ≥ 80% of participants complete 4-week assessments, and ≥ 50% elect to continue to the optional extended use period.
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Up to 12 weeks
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Usability of AI-powered supportive care chatbot
Periodo de tiempo: At end of intervention, assessed up to 12 weeks
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Usability will be supported if mean System Usability Scale scores are ≥ 70, indicating acceptable usability.
Will be described (i.e., means, medians, standard deviations, and ranges) at the post-intervention time point.
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At end of intervention, assessed up to 12 weeks
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Patient Reported Outcomes Measurement Information System measure
Periodo de tiempo: At baseline, 4 weeks, and/or 12 weeks
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Will be summarized using descriptive statistics (e.g., means, medians, standard deviations, and ranges) at each time point.
Changes over time (baseline, post-intervention, as applicable) will be examined descriptively.
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At baseline, 4 weeks, and/or 12 weeks
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Digital Health Literacy Scale
Periodo de tiempo: At baseline
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Will be summarized using descriptive statistics (e.g., means, medians, standard deviations, and ranges) at the baseline time point.
The Digital Health Literacy Scale is a 0 to 12 point score (based on 3 items), with higher scores indicating greater digital health care literacy.
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At baseline
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Interview themes and subthemes
Periodo de tiempo: At end of intervention, assessed up to 12 weeks
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The audio-recorded interviews will be transcribed verbatim by a professional transcription company and verified for accuracy by another study team member.
The finalized transcripts will be imported into NVivo 12 (QSR International Pty Ltd).
Inductive content analysis will be used to analyze the interview transcripts.
Two study team members will review the transcripts and the interview guide to create an initial list of codes.
Three transcripts will be independently coded using the initial codebook.
After three interviews are coded, two study team members will meet to resolve any coding discrepancies and to revise the codebook further.
The same process will be repeated after three more interviews are coded.
After the codebook is finalized, one study team member will code the remaining interviews.
Subsequently, the study team will meet as a group to review the transcripts in their entirety, making sense of the data and generating potential major themes and subthemes.
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At end of intervention, assessed up to 12 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Robert Knoerl, University of Michigan Rogel Cancer Center
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 (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de octubre de 2028
Finalización del estudio (Estimado)
1 de octubre de 2028
Fechas de registro del estudio
Enviado por primera vez
30 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de agosto de 2026
Publicado por primera vez (Actual)
19 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UMCC 2026.025
- NCI-2026-05454 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- HUM00288074 (Otro identificador: University of Michigan Rogel Cancer Center)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified participant data will be shared with other researchers upon reasonable request and execution of a data transfer agreement.
Marco de tiempo para compartir IPD
After publication of results and within 7 years after study completion.
Criterios de acceso compartido de IPD
De-identified participant data will be shared with other researchers upon reasonable request and execution of a data transfer agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
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
producto fabricado y exportado desde los 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. .