CClinicalTrials.gg
CompletedNCT05523700VIRGOUpdated Oct 10, 2025

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

An interventional study of Mobile Application in Ovarian Cancer, sponsored by Jonsson Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-10-10.

Sponsored by Jonsson Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
Female
01

Study summary

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.

Read the detailed description

The study will employ the complete utility of the mobile application by incorporating highly coordinated ovarian cancer care pathways, associated evidence-based recommendations, and delivering these 'at the fingertips' of providers and patients when appropriate. The AI-based mobile application requires both clinical data-input as well as continuously captured patient-reported outcome measures (PROMs) including those related to disease progression, medication side effects, medication adherence, anxiety and depression, and quality of life. The continuous assessment of outcome measures will provide ongoing monitoring that is delivered directly to the electronic medical record (EMR). This data allows abnormal outcome measures to trigger immediate expert-based recommendations for care management with one click in the EMR through implementation of the AI-driven ovarian cancer care pathways. Provider recommendations will be continuously generated for the optimization of care that is based upon individual risk profiles, disease stage, and health outcomes, resulting in dynamic and risk-dependent recommendations. Remote patient monitoring will also allow for improved education and instruction, including appointment reminders and medication adherence optimization. The application will also provide nutritional support, mental support, and caregiver connectivity. Given ovarian cancer will be a chronic condition for 80% of patients, the critical challenge is to deliver high level care that improves patient outcomes while not increasing the cost of health care. This project will assess a process by which this can be done with the electronic medical record, a patient application, and AI-generated patient care pathways. The development of such AI-powered care pathways designed for ovarian cancer will be coordinated throughout the induction and maintenance treatment phases of ovarian cancer management.

02

Conditions studied

  • Ovarian Cancer

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Keywords

  • Mobile Application
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Interventional Arm

    Use of Mobile Application

    Other: Mobile Application

  • No intervention
    Control Arm

    Routine care and symptom management

Interventions

  • OtherMobile Application

    Intervention is a mobile application than combines patient data via EMR with PROMIS outcome measures.

06

What researchers measure

Primary outcomes

  1. Assessment of the NFOSI-18 Function/Well-being subscale score between study groups

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

    Time frame: 12 months

Secondary outcomes

  1. Comparison of patient-reported outcome measures (FOSI)

    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.

    Time frame: 12 months

  2. Comparison of medication adherence (Adherence Index)

    Adherence Index

    Time frame: 12 months

  3. Comparison of patient activation scores (PAM-13)

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

    Time frame: 12 months

  4. Comparison of adverse events (including medication side-effects)

    Adverse Event Log tracking

    Time frame: 12 months

  5. Rate of comparison of healthcare utilization

    ER visits, hospitalizations, blood transfusions

    Time frame: 12 months

  6. Determine progression free survival rate

    Progression-free survival (PFS)

    Time frame: 12 months

  7. Determine Over-all survival (OS) rate

    Over-all survival (OS)

    Time frame: 12 months

07

Study locations

1 site
  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles, California 90095-1406, United States
08

References and documents

Individual participant data

Plan to share: No — Aggregate data will be published.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05523700
Lead sponsor
Jonsson Comprehensive Cancer Center
Collaborators
University of California, Davis, University of California, Irvine, University of California, San Francisco, University of California, San Diego
Responsible party
Sponsor
First posted
Aug 31, 2022
Start date
Oct 17, 2023
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025
Last update
Oct 10, 2025

Study contacts

Tiffany Lai, MD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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