Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT05523700

Not Yet Recruiting

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

Interventional

Phase not listed

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.

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Treatment Category

Other

Required Mutations

None

Trial Started

2023-10-17

Last Updated by Sponsor

2025-03-25

Estimated Completion

2026-10-01

Eligibility

Inclusion Criteria

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

Exclusion Criteria

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.

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Design Details

AllocationRandomized

Intervention ModelParallel Assignment

MaskingNone (Open Label)

Number to Enroll200

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: Use of Mobile Application

Interventions:

Mobile Application

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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Trial Sites

This study has 1 trial site

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

Recruiting

Los Angeles, California, 90095-1406 US

UCLA / Jonsson Comprehensive Cancer Center

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