Comprehensive Care Program for Cancer

Overseen By Yvonne Taul, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Timothy Mullett

Disqualifiers: Non-English speakers, No internet access

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

Trial Summary

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

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the C4 Program, Comprehensive Connected Cancer Care treatment?

The research on oncology nurse navigation programs shows that they improve coordination of care and patient satisfaction, which are important aspects of comprehensive cancer care. Additionally, clinical care pathways, similar to the C4 Program, have been shown to reduce complications and hospital stays in cancer patients, suggesting potential benefits for this treatment. ^{1 2 3 4 5}

What makes the C4 Program treatment unique for cancer care?

The C4 Program, or Comprehensive Connected Cancer Care, is unique because it focuses on coordinated care and patient self-management, using tools like tailored websites and appointment reminders to improve care delivery and survivorship outcomes, especially in underserved populations. ^{6 7 8 9 10}

What is the purpose of this trial?

The C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the coordination of care with supportive/ancillary care providers and community services through the use of patient navigation and a digital needs assessment and a closed-loop referral system and improves patient-centered communication and engagement in care through skills training for the healthcare team and provision of culturally appropriate patient educational tools and resources. The program components incorporate three areas that are critical to improving patient-centered care: coordination of care, patient-centered communication and engagement, and psychosocial care and other supportive services.

Research Team

Timothy Mullett, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

The C4 trial is for individuals utilizing healthcare services for cancer treatment. Participants should be willing to engage with a multi-level intervention program that includes patient navigation, digital tools for needs assessment and referrals, as well as educational resources.

Inclusion Criteria

Patients with one reported social determinants of health (SDOH) need OR patients at high-risk for SDOH needs based on demographic information (racial & ethnic minorities, medicaid/uninsured populations)

I have cancer that is either new or has returned, and I haven't started any treatment yet.

Willingness to provide informed consent to participate

Exclusion Criteria

Unable and/or unwilling to access the internet on a phone, tablet, or computer

I cannot understand or communicate in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Phase

Patients and sites are observed during a period of usual care, prior to introducing the C4 Program intervention. Data is collected via patient surveys and EHR data abstraction.

18 months

Implementation

Newly diagnosed patients are recruited and enrolled in the Implementation Group, and the same data is collected on them as in the Baseline Group.

4 months

Follow-up

Participants are monitored for overall survival and health-related quality of life after the intervention.

12 months

Treatment Details

Interventions

• C4 Program

Trial Overview This trial evaluates the C4 Program, which focuses on improving care coordination between patients and various healthcare providers through digital assessments and patient navigation. It also aims to enhance communication skills within healthcare teams and provide culturally appropriate education to patients.

Participant Groups

Group I: Implementation Experimental Treatment 1 Intervention

new sample of newly diagnosed patients (excluding anyone from the Baseline Phase) will be recruited and enrolled in the Implementation Group, and the same data will be collected on them that was collected in the Baseline Group, at the same time points

Group II: Baseline Phase Active Control 1 Intervention

Each site will complete an 18-month Baseline Phase, in which patients and sites are observed during a period of usual care, prior to introducing the C4 Program intervention. In this phase, a sample of newly diagnosed patients will be recruited and enrolled in the Baseline Group, and data will be collected on them via patient surveys and EHR data abstraction over a period of four months for most outcomes, except for overall survival, which will be assessed at 12 months after diagnosis

Who Is Running the Clinical Trial?

Timothy Mullett

Lead Sponsor

Trials

2

Recruited

800+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

Oncology nurse navigation programs significantly reduced the time from the first provider visit to the start of therapy for patients with hematologic malignancies, improving access to care.

Patient and provider satisfaction scores were high regarding the navigation program, although it did not lead to an increase in clinical trial enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology Nurse Navigation: Development and Implementation of a Program at a Comprehensive Cancer Center . Gordils-Perez, J., Schneider, SM., Gabel, M., et al.[2018]

The Patient-Centered Outcomes Research Partnership successfully trained 31 scholars from diverse health care organizations over a 2-year program, significantly improving their research skills and self-efficacy in patient-centered outcomes and comparative effectiveness research.

Participants reported high satisfaction (91%) with the program, indicating that such training can effectively enhance collaboration between researchers and health care systems to address evidence gaps and improve clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an experiential training program in patient-centered outcomes and comparative effectiveness research for diverse researcher communities and health care organizations. Buchwald, DS., Rogers, MH., Rose, BA., et al.[2023]

Implementing a comprehensive clinical care pathway for 55 patients undergoing major head and neck surgery significantly reduced pulmonary complications by 32.5% and shortened hospital stays by an average of 7.4 days.

The care pathway was found to be safe, with no increase in flap reoperation rates, suggesting it is an effective strategy for improving postoperative outcomes in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of pulmonary complications and hospital length of stay with a clinical care pathway after head and neck reconstruction. Yeung, JK., Dautremont, JF., Harrop, AR., et al.[2022]

A study of 307 prostate cancer patients in Mexico City found that those treated at the Mexican Institute of Social Security (IMSS) reported significantly better access to decision-making information (80.8%) compared to those at the Ministry of Health (SSA) (58.9%).

Overall, while patients perceived the quality of care as good, both hospitals showed low levels of supportive care for biopsychosocial needs, highlighting the need for a multidisciplinary approach to improve this aspect of patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quality of care in patients with prostate cancer treated in Mexico]. Tristán-Martínez, PD., Doubova, SV., Sauceda-Valenzuela, AL.[2023]

The Comparative Effectiveness Research (CER) program, funded with 1.1 billion USD, was initiated in 2009 to address significant research gaps in patient care by comparing at least two interventions.

By 2012, CER evolved into Patient-Centered Outcomes Research (PCOR), highlighting a shift towards focusing on outcomes that matter most to patients, while still maintaining the core goal of improving healthcare effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Different name, same meaning? Comparative effectiveness research and patient-centered outcomes research in the USA]. Gerhardus, A.[2019]

A systematic review of 22 articles involving 8,114 patients with cancer and multiple chronic conditions revealed that effective communication between primary care providers and oncologists is crucial for patient care coordination.

The study developed a Patient-centered Care Coordination framework that emphasizes the need for clear provider roles, accessible information, and individualized care to meet the complex needs of these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perspectives on primary care and oncology care coordination in the context of multiple chronic conditions: A systematic review. Hohmann, NS., McDaniel, CC., Mason, SW., et al.[2021]

Project CONNECT aims to improve care coordination for 500 complex cancer survivors with chronic conditions by implementing three evidence-based strategies, including an EHR-driven registry and co-locating a nurse practitioner within care teams.

The study will evaluate the effectiveness of these strategies on both system-level and patient-level outcomes, providing insights that could enhance care coordination in safety-net healthcare systems nationwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care coordination for complex cancer survivors in an integrated safety-net system: a study protocol. Lee, SJC., Jetelina, KK., Marks, E., et al.[2023]

Comprehensive cancer control (CCC) involves collaboration among various experts and partners to improve cancer care in communities, leading to better outcomes through coordinated efforts and resource sharing.

CCC aims to create comprehensive cancer plans and support systems that address the full spectrum of cancer-related needs, ultimately achieving greater impact than isolated programs could achieve alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In conclusion: the promise of comprehensive cancer control. True, S., Kean, T., Nolan, PA., et al.[2005]

The 4R Oncology model significantly improved self-management and delivery of interdependent care for breast cancer patients, with 79.9% of patients finding it useful, especially in safety-net settings where 87.6% reported its effectiveness.

Patients in the intervention cohort showed better clarity in care timing and higher referral rates to necessary care services compared to a historical cohort, indicating that the 4R model may help reduce disparities in cancer care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Novel 4R Oncology Care Planning Model in Breast Cancer: Impact on Patient Self-Management and Care Delivery in Safety-Net and Non-Safety-Net Centers. Trosman, JR., Weldon, CB., Rapkin, BD., et al.[2021]

The ConnectedCancerCare (CCC) intervention was found to be feasible and acceptable for women with early-stage breast cancer, with 82% of participants finding it easy to use and 86% willing to recommend it to others.

Women using CCC were more likely to schedule follow-up visits with their primary care provider and had better communication about provider roles, indicating that CCC may enhance patient engagement and knowledge in team-based cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the delivery of team-based survivorship care after primary breast cancer treatment through a multi-level intervention: a pilot randomized controlled trial. Wallner, LP., Abrahamse, P., Gargaro, JG., et al.[2023]

References

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

Oncology Nurse Navigation: Development and Implementation of a Program at a Comprehensive Cancer Center . [2018]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of an experiential training program in patient-centered outcomes and comparative effectiveness research for diverse researcher communities and health care organizations. [2023]

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

Reduction of pulmonary complications and hospital length of stay with a clinical care pathway after head and neck reconstruction. [2022]

4. Mexico pubmed.ncbi.nlm.nih.gov

[Quality of care in patients with prostate cancer treated in Mexico]. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[Different name, same meaning? Comparative effectiveness research and patient-centered outcomes research in the USA]. [2019]

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

Patient perspectives on primary care and oncology care coordination in the context of multiple chronic conditions: A systematic review. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Care coordination for complex cancer survivors in an integrated safety-net system: a study protocol. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

In conclusion: the promise of comprehensive cancer control. [2005]

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

Evaluation of the Novel 4R Oncology Care Planning Model in Breast Cancer: Impact on Patient Self-Management and Care Delivery in Safety-Net and Non-Safety-Net Centers. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Improving the delivery of team-based survivorship care after primary breast cancer treatment through a multi-level intervention: a pilot randomized controlled trial. [2023]