Clinical trial · Interventional
Value-based Integrated Recommendation Software Guiding Ovarian Cancer Treatment (VIRGO2)
NCT05523700CI-TRIAL-00096503VIRGOcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mobile Application | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional Arm
- description
- Use of Mobile Application
- interventionNames
- Other: Mobile Application
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Routine care and symptom management
Primary outcomes (1)
- measure
- Assessment of the NFOSI-18 Function/Well-being subscale score between study groups
- timeFrame
- 12 months
- description
- NFOSI-18 is the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Ovarian Symptoms Index. Higher scores imply better outcomes.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.