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

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer
• Intervention / Treatment: Other: Mobile Application

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Arm; Use of Mobile Application	Other: Mobile Application; Intervention is a mobile application than combines patient data via EMR with PROMIS outcome measures.
No Intervention: Control Arm; Routine care and symptom management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
Comparison of medication adherence (Adherence Index)	Adherence Index	12 months
Comparison of patient activation scores (PAM-13)	PAM-13 is the Patient Activation Measure. Scored as level 1-4. Higher scores imply better outcomes.	12 months
Comparison of adverse events (including medication side-effects)	Adverse Event Log tracking	12 months
Rate of comparison of healthcare utilization	ER visits, hospitalizations, blood transfusions	12 months
Determine progression free survival rate	Progression-free survival (PFS)	12 months
Determine Over-all survival (OS) rate	Over-all survival (OS)	12 months

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: University of California, San Diego; University of California, Davis; University of California, San Francisco; University of California, Irvine
• Investigators: Principal Investigator: Tiffany Lai, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Estimated): October 10, 2025
• Last Update Submitted That Met QC Criteria: October 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Mobile Application
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms
• Other Study ID Numbers: 22-000895

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregate data will be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No