- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06652347
Comprensión de las preferencias y opiniones de los adultos mayores sobre el uso de evaluaciones funcionales objetivas y geriátricas para la planificación del tratamiento del cáncer.
Facilitating the Engagement and Satisfaction of Older Adults in Their Cancer Care Planning: A Randomized Study to Understand the Preferences and Views of Older Adults Regarding the Use of Geriatric and Objective Functional Assessments for Cancer Treatment Planning
This Interventional clinical study aims to explore how receiving information about their health and physical abilities affects the treatment decisions of older adults. The study will look at whether sharing detailed assessments of their health and functional status helps older adults better understand their condition and make informed decisions about their care.
The main question it aims to answer is if providing this information changes the treatment priorities of older adults, helping them focus on what matters most to them in their medical care.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This randomized, interventional, cancer care delivery trial will test whether receipt of Geriatric Assessment (GA) and Objective Functional Status (OFS) assessment data affects older adults' treatment priorities. It will also assess the preferences of older adults for the collection, sharing, and use of their assessment data. Finally, it will explore whether less fit patients experience a lower level of satisfaction and a greater degree of regret with their decision to undergo anti-cancer therapy. This study will utilize a randomized design where participants will be randomized to either the intervention arm (early sharing of GA and OFS results) or to the control arm (delayed sharing of GA and OFS results). To assess patients' preferences for quality vs quantity of life, the investigators will use the Quality Quantity (QQ) questionnaire. All patients will complete this at baseline and then undergo their GA and OFS assessments. Patients randomized to the intervention group will be provided the results of their GA and OFS assessments, and then complete the QQ Questionnaire for a second time to assess for any changes following receipt of their assessment results. Patients randomized to the control group will undergo the assessments and complete the same questionnaire as the intervention group but will not receive the results of their GA and OFS assessments prior to completing the second QQ Questionnaire. For the control group, assessment results will be shared with patients after completion of the follow-up QQ Questionnaire. After reviewing their assessment results, patients in both groups will then complete a questionnaire that inquire about their preferences for receipt, use, and sharing of their assessment data. It will also inquire about the degree to which receipt of these data affected how they experienced their cancer care.
The Investigators will determine whether sharing of geriatric and OFS assessment results affected patients' treatment priorities by measuring the absolute change from baseline in the QQ questionnaire scores for quantity and quality of life, comparing the change in the intervention versus the control group. The Investigators will also describe patients' preferences for the collection, use and sharing of their assessment data as reported in the preferences questionnaire, both overall and by race/ethnicity. To explore differences in patients' satisfaction with their decision to pursue anti-cancer therapy by functional status level, participants will complete the "Was it Worth It" (WIWI) questionnaire at the first of either 1) the conclusion of their treatment regimen or 2) three months after enrollment. The provider assessment will ask whether patients experienced any of the following: a toxicity of treatment ≥grade 3, treatment dose reduction, treatment interruption, treatment discontinuation, hospitalization, or a decline in performance status.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Zachary Frosch, MD MSHP
- Número de teléfono: 215-728-2674
- Correo electrónico: Zachary.Frosch@fccc.edu
Copia de seguridad de contactos de estudio
- Nombre: Leslie J Fortin, MPH
- Número de teléfono: 215-214-3996
- Correo electrónico: Leslie.Fortin@fccc.edu
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Reclutamiento
- Fox Chase Cancer Center
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Contacto:
- Leslie J Fortin, MPH
- Número de teléfono: 215-214-3996
- Correo electrónico: Leslie.Fortin@fccc.edu
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Contacto:
- Gerald T Nkogbu, MBBS, MSc
- Número de teléfono: 215-214-5378
- Correo electrónico: gerald.nkogbu@fccc.edu
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Investigador principal:
- Zachary Frosch, MD, MSHP
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age ≥ 65
At the time of study screening either:
- Started a new qualifying index regimen within the last 30 days (inclusive)
- Are being considered for a new qualifying index regimen
Exclusion Criteria:
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Patients will be excluded if they
- Do not have the capacity to consent to study procedures
- Are unable to complete English language questionnaires
- Are already using an activity tracker on a daily basis (and therefore may be aware of their current level of activity)
- Are enrolled in another study in which physical activity is a substantial part or all of the therapeutic intervention or where physical activity is specifically being evaluated and shared with patients. Patients on studies not evaluating or sharing physical activity are eligible for the present study if they meet the other inclusion/exclusion criteria and participation in the present study is not excluded by other studies in which they are enrolled.
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 |
|---|---|
|
Experimental: Early Sharing Arm
early sharing of GA and OFS results to participants |
Early vs. delayed sharing of GA and OFS diagnostic results and how that sharing affects patient preferences, decision- making, and satisfaction in the context of participants' cancer care.
Otros nombres:
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|
Sin intervención: Delayed Sharing Arm
delayed sharing of GA and OFS results to participants |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Absolute change in QQ-Length of life from baseline to post-intervention
Periodo de tiempo: From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
|
The QQ uses a 5-point Likert scale to rate each of the 4 questions on the QQ-L subscale. The scores for this subscale are then summed, meaning that patients will receive a score ranging from 4-20 for the QQ-L. The total score from the 4 QQ-L items measures the strength of a participant's preference for length of life, with higher scores meaning greater preference for length of life. |
From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The secondary outcome will be the absolute change in the QQ quality of life subscale (QQ-Q) from baseline to post-intervention.
Periodo de tiempo: From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
|
The QQ uses a 5-point Likert scale to rate each of the 4 questions on the QQ-Q subscale. The scores for the subscale are then summed, meaning that patients will receive a score ranging from 4-20 for the QQ-Q. The total score from the 4 QQ-Q items measures the strength of a participant's preference for quality of life, with higher scores meaning greater preference for quality of life. |
From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The proportion of patients who, on the Was It Worth It (WIWI) questionnaire, report that their treatment was worthwhile, that they would undergo it again, and that they would recommend it to others.
Periodo de tiempo: From enrollment to the end of treatment or at 3 months after study entry, whichever comes first.
|
The proportion of patients who, on the Was It Worth It (WIWI) questionnaire, report that their treatment was worthwhile, that they would undergo it again, and that they would recommend it to others. |
From enrollment to the end of treatment or at 3 months after study entry, whichever comes first.
|
|
Summary/descriptive statistics for participants' answers to the preferences questionnaire.
Periodo de tiempo: From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
|
It inquires about their preferences for receipt, use and sharing of their assessment results, along with the degree to which receipt of these results affected their understanding or approach to their care |
From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Zachary Frosch, MD, MSHP, Fox Chase Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- Ensayo controlado aleatorizado
- seguimiento de actividad física
- Intervención de prestación de atención
- Estado funcional en adultos mayores
- Preferencias de tratamiento del cáncer
- Calidad versus cantidad de vida
- Resultados en oncología informados por los pacientes
- Calidad de vida en la atención del cáncer
- Evaluaciones de salud funcional
- Tratamiento del cáncer centrado en el paciente
Términos MeSH relevantes adicionales
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Terapéutica
- Procedimientos quirúrgicos, operativo
- Recopilación de datos
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Fenómeno fisiológico
- Crecimiento y desarrollo
- Técnicas cosméticas
- Encuestas y cuestionarios
- Envejecimiento
- Body Modification, Non-Therapeutic
Otros números de identificación del estudio
- 24-1020
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual Participant Data will not be shared due to privacy concerns.
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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