Oncology Dashboard for Sarcoma Management

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must be taking: Chemotherapy, Targeted therapy

Disqualifiers: Expected survival < 8 weeks, ECOG 4, Non-English, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 7

92 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial investigates whether measuring and presenting information about a patient's cancer treatment to them, their doctor, and their radiologist using a tool called an "oncology dashboard" may help patients understand the disease better and help the patient's medical team manage their care more efficiently. The oncology dashboard tool may help patients understand the disease better and may help improve the efficiency of their medical care.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. In fact, you need to continue the same therapy for the next 6-8 weeks to participate in the trial.

What data supports the effectiveness of the treatment Oncology Dashboard for sarcoma management?

The Oncology Dashboard uses a digital platform to track and analyze real-time data, which helps improve the quality of sarcoma care by using standardized quality indicators and patient-reported outcomes. This approach allows for better prediction modeling and decision-making, potentially leading to improved patient outcomes and more efficient healthcare management. ^{1 2 3 4 5}

What safety data exists for the Oncology Dashboard treatment?

The research articles do not provide specific safety data for the Oncology Dashboard treatment itself, but they highlight the importance of monitoring and addressing patient safety issues in oncology, including the use of electronic systems and real-world data from patient forums to identify adverse events. ^{6 7 8 9 10}

How is the Oncology Dashboard for Sarcoma Management treatment different from other sarcoma treatments?

The Oncology Dashboard for Sarcoma Management is unique because it uses a digital platform to integrate real-time data and patient-reported outcomes into the care process, allowing for personalized and precise treatment decisions. This approach focuses on improving the quality of care through standardized quality indicators and predictive modeling, which is not typically part of standard sarcoma treatments. ^{1 4 5 11 12}

Research Team

Vinod Ravi, M.D.

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adult sarcoma patients who are not being treated at MDACC but get their follow-up imaging there. They must have been on the same treatment for at least 6 weeks, with stable or mildly progressive disease, and plan to continue it for another 6-8 weeks. They need a history of regular imaging on the affected area and an ECOG performance status better than 4.

Inclusion Criteria

My cancer measurements are consistent and done while on the same treatment, unless my cancer has worsened.

I am currently receiving chemotherapy or targeted therapy for sarcoma.

I have had 3 or more scans of the same area, each 6 weeks apart.

Exclusion Criteria

Non-English-speaking patients and patients with cognitive impairment who cannot complete the questionnaire

I am unable to walk or care for myself.

Expected survival of less than 8 weeks

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of oncology and radiology workflow times and patient understanding of tumor size changes

1 week

1 visit (in-person)

Intervention

Patients are randomized to either receive standard of care or use the oncology dashboard tool to view changes in disease over time

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in workflow times, patient understanding, and satisfaction with communication

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Oncology Dashboard

Trial Overview The study tests if using an 'oncology dashboard'—a tool that displays patient cancer treatment data—can help patients understand their condition better and improve how doctors manage care. It involves best practices, questionnaires, and informational interventions.

Participant Groups

Group I: Group II (standard of care) Experimental Treatment 2 Interventions

Patients receive standard of care.

Group II: Group I (oncology dashboard) Experimental Treatment 2 Interventions

Radiologist records information from patient's recent scan into oncology dashboard. Patients view images of how disease may have changed over time on oncology dashboard.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The PERSARC model, developed from a cohort of 766 patients with primary soft-tissue sarcomas, effectively predicts overall survival and local recurrence rates based on treatment modalities and surgical outcomes.

Patients receiving radiotherapy in addition to surgery had significantly better overall survival and lower local recurrence rates compared to those who underwent surgery alone, highlighting the importance of combined treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prediction model for treatment decisions in high-grade extremity soft-tissue sarcomas: Personalised sarcoma care (PERSARC). van Praag, VM., Rueten-Budde, AJ., Jeys, LM., et al.[2018]

In a study analyzing 827 safety incident reports from a pediatric oncology unit over 18 months, approximately 79% of incidents were related to medication, with nearly 45% linked to the electronic medication management system (EMM).

The EMM contributed to safety issues through technical problems, user experience challenges, unexpected workflow issues, and missing safety features, highlighting the need for users to be aware of the system's automatic behaviors and to be prepared to troubleshoot them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication safety incidents in paediatric oncology after electronic medication management system implementation. Lichtner, V., Baysari, M., Gates, P., et al.[2020]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

A new screening tool was developed to identify adverse events (AEs) in cancer care, consisting of 76 specific triggers that can help detect potential safety issues during treatment.

This tool, which categorizes triggers related to general care, vital signs, medications, and laboratory tests, has the potential to improve patient safety and quality of care in oncology, although further testing is needed to validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ReCAP: Detection of Potentially Avoidable Harm in Oncology From Patient Medical Records. Lipitz-Snyderman, A., Weingart, SN., Anderson, C., et al.[2021]

A total of 3120 adverse event cases related to avapritinib were reported to the FDA, with 44% occurring within the first 30 days of treatment, highlighting the importance of monitoring patients closely during this period.

The study found that elderly male patients are at a higher risk for serious adverse events, indicating that clinicians should exercise caution when prescribing avapritinib to this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A post-marketing pharmacovigilance study of avapritinib: Adverse event data mining and analysis based on the United States Food and Drug Administration Adverse Event Reporting System database. Rong, L., Xie, M., Jiang, M., et al.[2023]

Patient forums can significantly enhance pharmacovigilance by providing real-time, uncensored reports of adverse drug events (ADEs) for rare cancers, as demonstrated in a case study on Gastrointestinal Stromal Tumor patients.

Using machine learning algorithms, the study identified that certain side effects, like cognitive impairment and alopecia from avapritinib, were reported at different rates compared to clinical trials, highlighting the potential of patient forums to uncover long-term and novel ADEs not previously documented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated gathering of real-world data from online patient forums can complement pharmacovigilance for rare cancers. Dirkson, A., Verberne, S., Kraaij, W., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Quality of Sarcoma Care: Longitudinal Real-Time Assessment and Evidence Analytics of Quality Indicators. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Sarcoma-Specific Instrument to Longitudinally Assess Health-Related Outcomes of the Routine Care Cycle. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Health-related quality of life, psychosocial functioning, and unmet health needs in patients with sarcoma: A systematic review. [2020]

4. England pubmed.ncbi.nlm.nih.gov

A prediction model for treatment decisions in high-grade extremity soft-tissue sarcomas: Personalised sarcoma care (PERSARC). [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Unlocking the Power of Benchmarking: Real-World-Time Data Analysis for Enhanced Sarcoma Patient Outcomes. [2023]

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

Medication safety incidents in paediatric oncology after electronic medication management system implementation. [2020]

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

Improving patient safety in the inpatient setting through risk assessment and mitigation. [2016]

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

ReCAP: Detection of Potentially Avoidable Harm in Oncology From Patient Medical Records. [2021]

9. England pubmed.ncbi.nlm.nih.gov

A post-marketing pharmacovigilance study of avapritinib: Adverse event data mining and analysis based on the United States Food and Drug Administration Adverse Event Reporting System database. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Automated gathering of real-world data from online patient forums can complement pharmacovigilance for rare cancers. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Improved survival using specialized multidisciplinary board in sarcoma patients. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Management and outcomes of adolescent and young adult sarcoma patients: results from the French nationwide database NETSARC. [2023]