Mobile App for Ovarian Cancer Treatment Guidance

(VIRGO Trial)

Overseen By Cortney M Eakin, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Non-gynecologic cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app to track health outcomes during your cancer treatment.

What data supports the effectiveness of the treatment VIRGO2 for ovarian cancer?

The ASCO value framework and NCCN guideline-adherent care studies suggest that using structured frameworks and guidelines can help in assessing and improving the value of ovarian cancer treatments, which may indirectly support the effectiveness of VIRGO2 in guiding treatment decisions. ^{1 2 3 4 5}

How does the mobile app for ovarian cancer treatment guidance differ from other treatments?

The mobile app for ovarian cancer treatment guidance is unique because it provides personalized treatment guidance through a digital platform, which may enhance patient engagement and adherence to treatment plans compared to traditional methods. This approach is novel as it leverages technology to support patients in managing their condition, potentially improving outcomes by offering real-time support and information. ^{1 2 5 6 7}

What is the purpose of this trial?

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.

Research Team

Tiffany Lai, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for women aged 18 or older with advanced ovarian, fallopian tube, or primary peritoneal cancer. Participants must be undergoing or about to start treatment within 30 days and have access to an iOS or Android smartphone. Those with other active cancers or conditions that could risk safety/data quality can't join.

Inclusion Criteria

I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.

I am a woman aged 18 or older.

I will start or am currently on cancer treatment like chemotherapy during the study.

Exclusion Criteria

Unwilling or unable to adhere to the informed consent

I am currently being treated for a non-gynecologic cancer.

Unwilling or unable to adhere to the protocol

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants begin treatment with the mobile application to manage ovarian cancer care pathways

12 months

Continuous remote monitoring

Maintenance Treatment

Ongoing use of the mobile application for continuous monitoring and management of ovarian cancer

12 months

Continuous remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

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

Trial Overview The study tests a mobile app designed to improve health outcomes by tracking patient-reported data alongside clinical information from medical records, aiming to enhance the care team's decision-making during treatments like chemotherapy.

Participant Groups

Group I: Interventional Arm Experimental Treatment 1 Intervention

Use of Mobile Application

Group II: Control Arm Active Control 1 Intervention

Routine care and symptom management

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Findings from Research

Dose-dense paclitaxel demonstrated the highest net health benefit (NHB) of 38 points at a relatively low additional cost of $16 per cycle, making it the most cost-effective frontline treatment for ovarian cancer.

In contrast, concurrent plus maintenance bevacizumab had the lowest NHB of 24 points with a high cost of $7,581 per cycle, indicating that while it is a treatment option, it offers less value compared to dose-dense paclitaxel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ASCO Value Framework Highlights the Relative Value of Treatment Options in Ovarian Cancer. Foote, J., Secord, AA., Liang, M., et al.[2018]

A cost-effectiveness analysis of an intervention to improve adherence to NCCN guidelines for ovarian cancer showed that a program costing $100 per patient and reducing non-adherence by 25% is highly cost-effective, with an incremental cost-effectiveness ratio (ICER) of $22 per year of life saved.

The study suggests that even more expensive interventions (up to $8000 per patient for targeted groups) can still be cost-effective, indicating that improving adherence to cancer care guidelines could significantly benefit patient outcomes and reduce racial disparities in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving NCCN guideline-adherent care for ovarian cancer: Value of an intervention. Dottino, JA., Cliby, WA., Myers, ER., et al.[2015]

Universal PARP inhibitor (PARPi) maintenance therapy for advanced ovarian cancer is more expensive and provides greater progression-free survival (PFS) benefits compared to a biomarker-directed approach, with costs per patient ranging from $166,269 to $366,506 depending on the trial.

The study found that the cost-effectiveness of the universal PARPi strategy is significantly lower than that of the biomarker-directed strategy, indicating that maintenance therapy should be limited to patients with specific genetic mutations until costs decrease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis comparing "PARP inhibitors-for-all" to the biomarker-directed use of PARP inhibitor maintenance therapy for newly diagnosed advanced stage ovarian cancer. Gonzalez, R., Havrilesky, LJ., Myers, ER., et al.[2021]

Adding bevacizumab to the standard treatment of paclitaxel and carboplatin for advanced-stage ovarian cancer results in higher costs and less favorable quality-adjusted cost-effectiveness, with PCB+B being the most expensive regimen at $122,700 for 1.25 quality-adjusted progression-free years.

Incorporating quality-of-life measures into the cost-effectiveness analysis significantly increased the incremental cost-effectiveness ratio for bevacizumab-containing regimens, highlighting the importance of considering patient quality of life in treatment evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cost-utility analysis of NRG Oncology/Gynecologic Oncology Group Protocol 218: incorporating prospectively collected quality-of-life scores in an economic model of treatment of ovarian cancer. Cohn, DE., Barnett, JC., Wenzel, L., et al.[2019]

A systematic review of follow-up care after primary treatment for endometrial and ovarian cancer found no evidence that such follow-up improves survival rates for patients, indicating a need to rethink its purpose.

Current follow-up methods, which primarily involve gynecologic examinations and ultrasounds, lack the sensitivity and specificity needed to effectively detect recurrences, suggesting that follow-up should focus on other outcomes like quality of life and treatment costs rather than just early detection of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of gynecologic cancer follow-up: evidence-based ignorance? Lajer, H., Jensen, MB., Kilsmark, J., et al.[2019]

In a study of 21 women with epithelial ovarian cancer under surveillance for recurrence, preferences for second-line treatment varied widely, with about half preferring to avoid chemotherapy or tamoxifen, even at the cost of life expectancy.

Most participants reported good psychological well-being during surveillance, indicating that individual preferences for treatment should be considered, as some women viewed early treatment as a positive coping mechanism despite having unrealistic expectations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rising cancer antigen 125 level and the type and timing of treatment for recurrent ovarian cancer: a clinical dilemma, but what would women do? Harrison, JD., Juraskova, I., Anderson, C., et al.[2018]

Maintenance therapy with letrozole for patients with low grade serous ovarian cancer (LGSC) is cost-effective, showing a lifetime cost of approximately $69,985 CAD and improving quality-adjusted life years (QALYs) by 0.91 compared to routine observation.

Letrozole maintenance therapy also significantly enhances overall survival, with a median of 150 months compared to 126 months for observation, and reduces the rate of disease recurrences by 34% at 5 years and 17% at 10 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of maintenance hormonal therapy in patients with advanced low grade serous ovarian cancer. Nica, A., Lee, JYJ., Hong, NL., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

ASCO Value Framework Highlights the Relative Value of Treatment Options in Ovarian Cancer. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Improving NCCN guideline-adherent care for ovarian cancer: Value of an intervention. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis comparing "PARP inhibitors-for-all" to the biomarker-directed use of PARP inhibitor maintenance therapy for newly diagnosed advanced stage ovarian cancer. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A cost-utility analysis of NRG Oncology/Gynecologic Oncology Group Protocol 218: incorporating prospectively collected quality-of-life scores in an economic model of treatment of ovarian cancer. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The value of gynecologic cancer follow-up: evidence-based ignorance? [2019]

6. England pubmed.ncbi.nlm.nih.gov

Rising cancer antigen 125 level and the type and timing of treatment for recurrent ovarian cancer: a clinical dilemma, but what would women do? [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of maintenance hormonal therapy in patients with advanced low grade serous ovarian cancer. [2021]