Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT06693687

Reclutamiento

A Study of the ApricityCare Program for Early Detection and Management of Treatment-Related Adverse Events in Patients With Cancer

Intervencionista

Fase no especificada

MD Anderson Cancer Center

To evaluate the rate of therapy discontinuation due to toxicity (side effects) among participants with cancer using ApricityCare.

Investigators want to learn if identification of early clinical signs of irAEs with timely treatment can prevent severity progression and reduce treatment discontinuation.

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Categoría de tratamiento

Comportamiento

Erforderliche Mutationen

Ninguna

Ensayo iniciado

2024-12-18

Última actualización por el patrocinador

2025-12-30

Finalización estimada

2027-11-01

Contacto del estudio

Nombre:Bilal A Siddiqui, MD

Correo electrónico:basiddiqui@mdanderson.org

Teléfono:(713) 563-4600

Elegibilidad

Criterios de inclusión

* Age 18 years of age or older

* Confirmed diagnosis of cancer

* Part 1 (Run-in Phase): Only patients with prostate, kidney, and/or bladder cancer will be enrolled with either localized or metastatic disease.

* Part 2 (Expansion Phase): Metastatic patients will be enrolled. Note, evaluable metastatic patients from Ppart 1 will be counted in Cohort A as described in section 8.4.

* Planned to receive systemic anti-cancer therapy

* Ability to understand and the willingness to sign a written informed consent document

* Ability to speak, read, and understand one of the following languages: English, Spanish, Mandarin and Cantonese Chinese

* Ownership of a smartphone and willingness to use it as outlined by the protocol and described in the ICF

Criterios de exclusión

- Have any medical, psychological, or social condition that, in the opinion of the investigator would preclude participation in this study (pregnancy is not exclusionary and pregnant women will be permitted to enroll in the study).

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Detalles del diseño

AsignaciónN/A

Modelo de intervenciónSingle Group Assignment

EnmascaramientoNone (Open Label)

Número a inscribir425

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Other

Descripción: Participants will have 24/7 access to the ApricityCare service. Participants can check in and report any symptoms or side effects through the ApricityCare app, or by phone, at any time. Participants will be asked to report your status at least weekly, even if participants are not experiencing any side effects. ApricityCare nurses will review each participants report and provide appropriate education and/or virtual management or escalate, as needed, to the study doctor or emergency service, based on guidelines. Each encounter with an ApricityCare nurse will be sent to the electronic health record (EHR) in real time for review/inclusion into your medical record. For any in-person visits participants attend, the study doctor will review the ApricityCare symptom summary with participants. For all these visits, please bring your smartphone, which carries the ApricityCare application, for this review.

Intervenciones:

Metastatic Cancer

Medidas de resultado

Medidas de resultado primarias

Safety and Adverse EventsThrough study completion; an average of 1 year.

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03

Medidas de resultado secundarias

Ninguno

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Sitios del ensayo

Este estudio tiene 1 sitio de ensayo

MD Anderson Cancer Center

Houston, Texas, US

Nombre:Bilal A Siddiqui, MD

Correo electrónico:713-563-4600

Teléfono:basiddiqui@mdanderson.org

Reclutando

Houston, Texas, 77030 US

MD Anderson Cancer Center

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