Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT05523700

Non ancora in reclutamento

VIRGO: Value-based Integrated Recommendation Software Guiding Ovarian Cancer Treatment (VIRGO2)

Interventistico

Fase non elencata

UCLA / Jonsson Comprehensive Cancer Center

This study will evaluate the use of a mobile application in improving the patient-reported health outcome measures (PROMIS) for patients diagnosed with advanced stage ovarian, fallopian tube, and primary peritoneal cancer. The application will incorporate clinical data from the patient's medical chart as well as capture patient-reported outcome measures on an ongoing basis to better inform physicians and the care team so that necessary interventions may be implemented.

Mostra Descrizione Dettagliata

Categoria di Trattamento

Altri

Mutazioni richieste

Nessuno

Studio Iniziato

2023-10-17

Ultimo Aggiornamento dello Sponsor

2025-03-25

Completamento Stimato

2026-10-01

Idoneità

Criteri di Inclusione

1. Female ≥18 years of age at Screening Visit.

2. Diagnosed with ovarian cancer, fallopian tube, or primary peritoneal cancer

3. Undergoing active treatment at some point during the study period including chemotherapy, immunotherapy, targeted agent or hormonal therapy. If active treatment has not yet started at time of screening, active treatment must be anticipated to begin within 30 days of enrollment.

4. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

5. Access to IOS or Android-based smart phone

Criteri di Esclusione

1. Unwilling or unable to adhere to the protocol

2. Unwilling or unable to adhere to the informed consent

3. Age <18yo

4. Concurrent non-gynecologic cancer diagnosis requiring active treatment at enrollment

5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Pensi che questo studio appaia erroneamente?

Dettagli del Disegno

AllocazioneRandomized

Modello di InterventoParallel Assignment

MascheramentoNone (Open Label)

Numero da Arruolare200

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: Use of Mobile Application

Interventi:

Mobile Application

Misure di Esito

Misure di Esito Primarie

Assessment of the NFOSI-18 Function/Well-being subscale score between study groups12 months

NFOSI-18 is the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Ovarian Symptoms Index. Higher scores imply better outcomes.

Misure di Esito Secondarie

Comparison of patient-reported outcome measures (FOSI)12 months

FOSI-8 is the Functional Assessment of Cancer Therapy-Ovarian Symptoms Index-8 Item version (range 0-32). Higher scores imply better outcomes. This will not be compared between groups as it is only collected in the intervention arm.

Comparison of medication adherence (Adherence Index)12 months

Adherence Index

Comparison of patient activation scores (PAM-13)12 months

PAM-13 is the Patient Activation Measure. Scored as level 1-4. Higher scores imply better outcomes.

Comparison of adverse events (including medication side-effects)12 months

Adverse Event Log tracking

Rate of comparison of healthcare utilization12 months

ER visits, hospitalizations, blood transfusions

Determine progression free survival rate12 months

Progression-free survival (PFS)

Determine Over-all survival (OS) rate12 months

Over-all survival (OS)

Interessato a partecipare?

Scopri di più su questo studio e se potresti essere idoneo a partecipare.

Aggiungi studio ai preferiti

Condividi Studio via Email

Scarica lo studio

Pensi che questo studio appaia erroneamente?

Segnala Studio

Scarica lo studio

Siti dello Studio

Questo studio ha 1 sito

UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, US

In fase di reclutamento

Los Angeles, California, 90095-1406 US

UCLA / Jonsson Comprehensive Cancer Center

Loading Maps...