Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT06693687

Rekrutierung

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

Interventionsstudie

Phase nicht angegeben

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.

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Verhalten

Erforderliche Mutationen

Keine

Studie gestartet

2024-12-18

Zuletzt vom Sponsor aktualisiert

2025-12-30

Voraussichtlicher Abschluss

2027-11-01

Studienkontakt

Name:Bilal A Siddiqui, MD

E-Mail:basiddiqui@mdanderson.org

Telefon:(713) 563-4600

Eignung

Einschlusskriterien

* 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

Ausschlusskriterien

- 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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Design-Details

ZuteilungN/A

InterventionsmodellSingle Group Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer425

Arme & Interventionen

Arme

Interventionen

Typ: Other

Beschreibung: 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.

Interventionen:

Metastatic Cancer

Ergebnismessungen

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Keine

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Studienzentren

Diese Studie hat 1 Studienzentrum

MD Anderson Cancer Center

Houston, Texas, US

Name:Bilal A Siddiqui, MD

E-Mail:713-563-4600

Telefon:basiddiqui@mdanderson.org

Rekrutierend

Houston, Texas, 77030 US

MD Anderson Cancer Center

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