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

NCT05523700 | Completed

• 1 other identifier: 22-000895
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Keywords

Mobile Application

Outcome Measures

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.

  12 months

Secondary Outcomes (7)

• Comparison of patient-reported outcome measures (FOSI)

  12 months

• Comparison of medication adherence (Adherence Index)

  12 months

• Comparison of patient activation scores (PAM-13)

  12 months

• Comparison of adverse events (including medication side-effects)

  12 months

• Rate of comparison of healthcare utilization

  12 months

Study Arms (2)

Interventional Arm

EXPERIMENTAL

Use of Mobile Application

Other: Mobile Application

Control Arm

NO INTERVENTION

Routine care and symptom management

Interventions

Mobile Application OTHER

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

Interventional Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Must have been diagnosed with ovarian cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• University of California, Davis: collaborator
• University of California, Irvine: collaborator
• University of California, San Francisco: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095-1406, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Tiffany Lai, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective multicenter, randomized control trial to assess the efficacy of an AI-based recommendation program to improve healthcare outcomes in women with ovarian, fallopian tube, or primary peritoneal cancer occurring in the outpatient setting.

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 31, 2022
• Study Start: October 17, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: October 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)