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Completed

NCT Number: NCT05523700

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

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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Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095-1406, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female ≥18 years of age at Screening Visit.
  • Diagnosed with ovarian cancer, fallopian tube, or primary peritoneal cancer
  • 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.
  • 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.
  • Access to IOS or Android-based smart phone

Exclusion criteria

  • Unwilling or unable to adhere to the protocol
  • Unwilling or unable to adhere to the informed consent
  • Age <18yo
  • Concurrent non-gynecologic cancer diagnosis requiring active treatment at enrollment
  • 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.

Treatment and study plan

Mobile application

Other

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

Primary outcomes

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

    Time frame: 12 months

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

Secondary outcomes

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

    Time frame: 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.

  2. Comparison of medication adherence (Adherence Index)

    Time frame: 12 months

    Adherence Index

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

    Time frame: 12 months

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

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

    Time frame: 12 months

    Adverse Event Log tracking

  5. Rate of comparison of healthcare utilization

    Time frame: 12 months

    ER visits, hospitalizations, blood transfusions

  6. Determine progression free survival rate

    Time frame: 12 months

    Progression-free survival (PFS)

  7. Determine Over-all survival (OS) rate

    Time frame: 12 months

    Over-all survival (OS)

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • University of California, Davis
  • University of California, Irvine
  • University of California, San Diego
  • University of California, San Francisco

Registry information

Acronym: VIRGO

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 31, 2022
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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