CONNECT Platform for Cancer Care

(PARTNERS Trial)

Overseen By Richard Hoehn

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Inability to consent

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

Compensation: Varies

Number of Visits: 4

375 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the CONNECT platform treatment for cancer care?

Research suggests that using electronic patient-reported outcomes (ePROs) can improve cancer care by enhancing patient quality of life and reducing hospital visits. This indicates that platforms like CONNECT, which likely use similar methods, could be effective in improving cancer care. ^{1 2 3 4 5}

What safety data exists for the CONNECT Platform for Cancer Care?

The research articles discuss various tools and methods to identify and manage adverse events (unwanted side effects) in cancer treatment, which can help improve patient safety. These include developing specific tools to flag potential adverse events, describing the occurrence and severity of adverse events in hospitalized patients, and using electronic platforms for patients to report and manage adverse events during treatment. This information suggests a focus on improving safety in cancer care, although it does not specifically mention the CONNECT Platform. ^{6 7 8 9 10}

How is the CONNECT platform treatment different from other cancer treatments?

The CONNECT platform is unique because it uses a web-based system to connect healthcare professionals from different locations, allowing them to collaborate and make informed decisions about cancer care. This approach is particularly beneficial in low-resource settings, where access to a wide range of expert opinions can improve treatment outcomes. ^{11 12 13 14 15}

What is the purpose of this trial?

The purpose of this research is to evaluate a novel, integrated approach to providing navigation services to improve cancer outcomes and quality of life.

Research Team

Erika Trapl, PhD

Principal Investigator

Case Western Reserve University, Case Comprehensive Cancer Center

Eligibility Criteria

This clinical trial is open to individuals who are currently dealing with cancer. The main requirement is that they need help navigating their care and resources to improve their outcomes and quality of life.

Inclusion Criteria

Investigators will identify individuals who have either had a cancer screening with a suspicious finding or those individuals referred to the UH Seidman Diagnostic Clinic

Investigators will recruit individuals who identify as African American, Hispanic, or living in a prioritized geography as defined by zip code ADI>=75%ile for state

Exclusion Criteria

Any participant who is not willing or able to complete an informed consent form

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Patient Navigation Services

Participants have access to a Patient Navigator to help navigate and connect to local resources. The navigator will track support services and referrals provided.

4 months

Initial visit followed by contact at 4 months

Follow-up

Participants are reassessed for current needs, quality of life, and areas where additional support is needed.

4 months

Treatment Details

Interventions

• CONNECT platform

Trial Overview The trial is evaluating the CONNECT platform, which is a new integrated approach designed to assist patients in managing their cancer treatment by providing navigation services.

Participant Groups

Group I: Patient Navigation Services Experimental Treatment 1 Intervention

Following the consent process, participant will have access to a Patient Navigator, who will serve as a resource for during the time in the study to help navigate and get connected to local resources. The Patient Navigator will keep track of the kinds of support services and referrals provided. The Patient Navigator will contact the participant in 4 months to reassess current needs, quality of life, and areas where additional support is needed.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

Daily electronic patient-reported outcomes (ePROs) significantly improved symptom management for 217 cancer patients undergoing treatment, with over 50% of assessments generating alerts for moderate to severe symptoms.

The study found that red alerts (indicating severe symptoms) were often detected without prior warnings, and these alerts were linked to a higher likelihood of acute care visits, highlighting the importance of regular monitoring in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of a Remote Monitoring Program for Symptoms Among Adults With Cancer Receiving Antineoplastic Therapy. Daly, B., Nicholas, K., Flynn, J., et al.[2022]

Patient-reported outcome measure (PROM) feedback interventions in oncology showed a positive impact on health-related quality of life (HRQL) and patient-healthcare provider communication, with a moderate effect size based on a meta-analysis of 29 studies involving 7071 cancer patients.

The intervention also demonstrated a significant improvement in 1-year overall survival rates, suggesting that providing feedback can enhance care processes and outcomes for cancer patients, although the findings are limited by a high risk of bias in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of routine provision of feedback from patient-reported outcome measurements for cancer care improvement: a systematic review and meta-analysis. Lu, SC., Porter, I., Valderas, JM., et al.[2023]

The study involved interviews with 14 Iranian nurses to explore their experiences and perceptions of palliative care outcomes for cancer patients, revealing that palliative nursing is viewed as an abstract concept.

Two main themes emerged: 'providing excellent palliative care,' which emphasizes the importance of a humanistic approach and unique nursing qualities, and 'palliative care as an alarm,' highlighting the challenges and concerns nurses face in delivering care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Nursing for Cancer Patients as an Abstract Concept: A Hermeneutic Study. Borimnejad, L., Mardani-Hamooleh, M., Seyedfatemi, N., et al.[2018]

The imPROVE platform was developed through user-centered design and agile methods, incorporating feedback from 28 breast cancer care experts and 28 patients, aiming to enhance the collection and use of patient-reported outcomes (PRO) in breast cancer care.

This innovative platform includes a mobile application for patients and a clinician dashboard, integrating standardized outcome measures, which has the potential to significantly improve patient care delivery and engagement in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-centered design and agile development of a novel mobile health application and clinician dashboard to support the collection and reporting of patient-reported outcomes for breast cancer care. Tsangaris, E., Edelen, M., Means, J., et al.[2022]

The Tell Us™ Web-based tool was developed to enhance communication and symptom management among hospice and palliative care patients, caregivers, and providers, based on feedback from clinicians and researchers.

This tool allows for the collection of patient-reported outcomes, automated alerts for providers regarding patient needs, and educational resources, aiming to improve proactive patient management and overall care effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tell Us™: a Web-based tool for improving communication among patients, families, and providers in hospice and palliative care through systematic data specification, collection, and use. Dy, SM., Roy, J., Ott, GE., et al.[2022]

The eRAPID system allows cancer patients to securely report adverse events (AEs) online during treatment, providing real-time data to clinicians and immediate self-management advice for different severity levels of AEs.

A randomized controlled trial is currently evaluating the effectiveness of eRAPID in improving AE reporting and management among breast, gynecological, and colorectal cancer patients, with adaptations being tested for other treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an integrated electronic platform for patient self-report and management of adverse events during cancer treatment. Holch, P., Warrington, L., Bamforth, LCA., et al.[2022]

In a study of 322,887 cancer patients undergoing treatment, 19% experienced oncology-specific adverse events, with higher rates in those with metastatic cancers (41% for colorectal and 50% for lung cancer).

The most common triggers for these adverse events included abnormal serum bicarbonate levels and blood transfusions, highlighting the need for targeted monitoring in cancer care to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data. Weingart, SN., Nelson, J., Koethe, B., et al.[2021]

In the ICON8 ovarian cancer clinical trial, 51,019 adverse events were reported, but only 61% of serious adverse events were matched to existing adverse events, indicating a significant gap in safety reporting.

Re-analyzing safety data by including serious adverse events increased the detection of grade 3 or worse safety events, highlighting the importance of comprehensive safety data collection for accurate risk assessment in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial. James, EC., Dunn, D., Cook, AD., et al.[2021]

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]

In a study of 224 hospitalized oncology patients in Switzerland, 42% experienced at least one adverse event (AE) related to care, with pain and constipation being the most common issues identified.

Among the AEs, 61% were deemed not preventable, highlighting the need for improved safety measures in oncology care to reduce the occurrence of these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Describing adverse events in Swiss hospitalized oncology patients using the Global Trigger Tool. Gerber, A., Da Silva Lopes, A., Szüts, N., et al.[2022]

Telecollaboration through web-based platforms allows neurosurgeons in low- and middle-income countries to access expert opinions on challenging tumor cases, enhancing decision-making for patient care.

In a specific case involving a 5-year-old boy in Western Kenya, a multinational group of neurosurgeons provided valuable input on a complex tumor case, demonstrating the effectiveness of this model in improving treatment options in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An online tumor board with international neurosurgical collaboration guides surgical decision-making in Western Kenya. Henderson, F., Lepard, J., Seibly, J., et al.[2021]

Virtual tumor boards (VTBs) significantly enhance the speed and efficiency of cancer care, with an average response time of less than 24 hours for case reviews, allowing for quicker expert analysis and decision-making.

In a review of the Xcures VTB, 76% of patients had primary central nervous system tumors, and 44% of those with confirmed treatments opted for the VTB integrated option, highlighting its importance in managing complex cases like glioblastoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emergence of Virtual Tumor Boards in Neuro-Oncology: Opportunities and Challenges. Ekhator, C., Kesari, S., Tadipatri, R., et al.[2022]

The Onc'Idec platform in the Auvergne region enhances cancer care by coordinating private practice nurses to connect home and hospital care for patients.

By mapping the entire cancer patient pathway, the platform aims to improve the overall care experience for both healthcare professionals and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An oncology nursing coordination platform for the return home]. Rey, P.[2016]

The pilot experiment involved 47 health professionals in a sarcoma group, who utilized an online platform to anonymously discuss clinical imaging cases, resulting in 87 published cases and 261 responses over 13 months.

The platform improved response times significantly, from an average of 15 days to just 1.1 days, and facilitated discussions for both diagnosis/treatment requests and continuous medical training, highlighting its effectiveness and efficiency in enhancing multidisciplinary collaboration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Case report forum: the example of French sarcoma group multidisciplinary discussion tools. Sarcomes de la FNCLCC]. Labrèze, L., Bui, BN., Coindre, JM., et al.[2009]

A facility developed a web-based portal to connect oncology patients with various programs and services, enhancing their access to care.

This innovative approach aims to improve patient support and streamline the process of finding necessary resources for cancer treatment and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based tools steer patient-focused care. Delenardo, C.[2004]

References

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

Analysis of a Remote Monitoring Program for Symptoms Among Adults With Cancer Receiving Antineoplastic Therapy. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of routine provision of feedback from patient-reported outcome measurements for cancer care improvement: a systematic review and meta-analysis. [2023]

3. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Palliative Nursing for Cancer Patients as an Abstract Concept: A Hermeneutic Study. [2018]

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

User-centered design and agile development of a novel mobile health application and clinician dashboard to support the collection and reporting of patient-reported outcomes for breast cancer care. [2022]

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

Tell Us™: a Web-based tool for improving communication among patients, families, and providers in hospice and palliative care through systematic data specification, collection, and use. [2022]

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

Development of an integrated electronic platform for patient self-report and management of adverse events during cancer treatment. [2022]

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

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial. [2021]

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

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

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

Describing adverse events in Swiss hospitalized oncology patients using the Global Trigger Tool. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

An online tumor board with international neurosurgical collaboration guides surgical decision-making in Western Kenya. [2021]

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

The Emergence of Virtual Tumor Boards in Neuro-Oncology: Opportunities and Challenges. [2022]

13. France pubmed.ncbi.nlm.nih.gov

[An oncology nursing coordination platform for the return home]. [2016]

14. France pubmed.ncbi.nlm.nih.gov

[Case report forum: the example of French sarcoma group multidisciplinary discussion tools. Sarcomes de la FNCLCC]. [2009]

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

Web-based tools steer patient-focused care. [2004]