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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an "oncology dashboard" can help people with sarcoma and their healthcare teams better understand and manage the disease. The dashboard collects and displays information about the patient's cancer treatment, potentially improving care efficiency and patient understanding. Some participants will use the dashboard, while others will continue with the standard treatment process for comparison. This trial suits those who have sarcoma, are on active chemotherapy or targeted therapy, and have had at least three prior imaging tests at MD Anderson Cancer Center. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future sarcoma 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 prior data suggests that the oncology dashboard is safe for sarcoma management?

Research has shown that specific safety information is not available for the oncology dashboard used in managing sarcoma. This tool assists patients and their medical teams by displaying details about the patient's cancer treatment and its progression over time. As it is not a drug, it typically lacks the side effects associated with medications. Instead, it aims to enhance communication and understanding between patients and healthcare providers.

The trial is in a "not applicable" phase, indicating it does not test a drug or a surgical procedure. This suggests no known safety risks from using the oncology dashboard itself. In such cases, potential risks usually concern data privacy or user comprehension of the tool, rather than physical health risks.

In summary, the oncology dashboard is considered safe for managing sarcoma because it does not involve medication or surgery. However, no specific research data exists on safety issues related to the dashboard. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Oncology Dashboard for sarcoma management because it offers a new way to visualize and track disease progression. Unlike traditional treatments that rely solely on standard care, this dashboard allows patients to see images of how their disease may have changed over time. This can empower patients with more information and potentially improve communication between patients and healthcare providers. By integrating digital tools into sarcoma management, the Oncology Dashboard aims to enhance patient understanding and engagement, which could lead to more personalized care strategies.

What evidence suggests that the oncology dashboard is effective for sarcoma management?

Research shows that an oncology dashboard, which participants in this trial may experience, can help doctors better manage and understand sarcoma care. One study found that this digital tool improved the accuracy of cancer staging, increasing from 29% to 64% over two years. Other studies have found that sharing real-time data and patient feedback through these dashboards can improve patient outcomes. This tool enables medical teams to track changes in cancer over time, simplifying the management of treatment plans. Early signs suggest that both patients and doctors benefit from clear, visual information about disease progression. ^{1 6 7 8 9}

Who Is on the Research Team?

Vinod Ravi, M.D.

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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Oncology Dashboard for Sarcoma Management

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