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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to cancer care using the CONNECT platform to assist patients in navigating their treatment and improving their quality of life. Participants will have access to a Patient Navigator, who connects them with local resources and support services. The trial targets individuals who have received a suspicious result from a cancer screening or are visiting a specific diagnostic clinic. Eligibility may extend to those identifying as African American, Hispanic, or residing in certain areas based on zip code.

As an unphased trial, this study provides a unique opportunity to access personalized support and resources to enhance the cancer care journey.

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 prior data suggests that the CONNECT platform is safe for cancer care?

Research has shown that the CONNECT platform is generally safe to use. Past studies have employed tools and methods to identify and manage side effects, emphasizing safety and patient well-being.

The platform primarily uses telemedicine to assist cancer patients in managing their care, connecting them with resources and support through digital technology. Previous reports on similar telemedicine systems indicate that users generally tolerate them well, with no major safety concerns reported.

Since the CONNECT platform is designed to help patients access resources and support, it is unlikely to cause direct physical harm. Instead, it aims to simplify and enhance the cancer care process. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CONNECT platform because it offers a personalized approach to cancer care through Patient Navigation Services. Unlike traditional treatments that focus solely on medical interventions, this platform provides patients with a dedicated Patient Navigator to guide them to local resources and support services. This individualized support aims to improve the patient's quality of life by addressing their unique needs and offering reassessments over time. By integrating comprehensive support beyond medical treatment, the CONNECT platform hopes to enhance overall patient care and outcomes.

What evidence suggests that the CONNECT platform is effective for improving cancer outcomes?

Research has shown that digital tools like CONNECT can improve cancer care. In one study, older cancer patients using a similar tool communicated better with their doctors. Another study found that patients using remote monitoring required fewer hospital visits. Technology-based support also helps lung cancer patients manage their treatment more effectively. Additionally, telehealth has proven both effective and convenient for breast cancer patients. These findings suggest that the CONNECT platform, which participants in this trial will use, may enhance cancer care and improve patients' quality of life. ^{5 6 7 8 9}

Who Is on the Research Team?

Erika Trapl, PhD

Principal Investigator

Case Western Reserve University, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10203955/

Effectiveness of electronic patient reporting outcomes, by a ... Effectiveness of a digital telemonitoring platform for cancer care of older patients: The ConnectElderlyPatientToDoctor study—PubMed.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.1581

Improving cancer patient care with a digital telemonitoring ... Conclusions: Participants in ConnectPatientToDoctor study reported that they had a clear benefit from using a connected platform to monitor ...

3. nature.com nature.com/articles/s41746-025-01913-7

Systematic review on the technology's role in supporting ... This systematic review examines the role of technology-based interventions in supporting lung cancer patients during their treatment.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833891

Remote Symptom Monitoring With Electronic Patient ... This nonrandomized controlled trial found that RSM implementation was associated with reduced risk of hospitalizations for patients with cancer.

5. academic.oup.com academic.oup.com/oncolo/article/29/11/e1470/7715784

Patient-reported convenience and effectiveness of telehealth ... Our results indicate that telehealth can serve as an effective and satisfactory approach for delivering healthcare services to patients with breast cancer ...

6. withpower.com withpower.com/trial/phase-malignancies-8-2024-eafa1

CONNECT Platform for Cancer Care (PARTNERS Trial) What safety data exists for the CONNECT Platform for Cancer Care? The research articles discuss various tools and methods to identify and manage adverse ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8832259/

The Use of Telemedicine in Cancer Clinical Trials This study aimed to demonstrate the feasibility of telemonitoring and patient-reported outcomes collection in the context of clinical trials.

8. dceg.cancer.gov dceg.cancer.gov/research/who-we-study/cohorts/connect

Connect for Cancer Prevention Study - NCI The Connect for Cancer Prevention Study is a new prospective cohort of 200000 adults in the United States designed to further investigate the etiology of ...

9. mayoclinicplatform.org mayoclinicplatform.org/mayo-clinic-platform-connect/

Mayo Clinic Platform_Connect Mayo Clinic Platform_Connect is a distributed data network program that partners with health systems to enable better ways to treat and prevent disease.