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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to improve cancer care coordination and communication. It aims to assist patients by strengthening connections with supportive services and enhancing communication with healthcare teams. The program, called the C4 Program (Comprehensive Connected Cancer Care), uses digital tools and patient education to make care more patient-focused. Individuals newly diagnosed with cancer who have not yet started treatment, particularly those facing challenges like financial hardship, are ideal candidates for this trial. Participants must be able to communicate in English and use the internet. As an unphased trial, this study offers patients the opportunity to contribute to innovative approaches in cancer care coordination.

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 prior data suggests that the C4 Program is safe for cancer patients?

Research has shown that the C4 Program aims to improve cancer care by making it more personalized and connected for each patient. It enhances collaboration among doctors and healthcare teams and provides patients with essential tools and support.

As a program rather than a drug or medical procedure, it does not involve side effects. The main goal is to enhance communication and teamwork between patients and healthcare teams. The program seeks to improve the overall experience for cancer patients by ensuring they receive the necessary support.

For those considering joining, it's important to know that this program focuses on improving how care is delivered, not on introducing new medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Comprehensive Care Program for Cancer because it aims to improve patient outcomes by integrating personalized care with standard treatment protocols. Unlike traditional cancer treatments that often focus solely on medication or surgery, this program emphasizes a holistic approach, combining medical care with patient education, psychosocial support, and lifestyle adjustments. The goal is to not only address the cancer itself but also enhance the overall quality of life and long-term health of patients. By collecting comprehensive data during both the baseline and implementation phases, researchers hope to demonstrate how such an integrated approach can be more effective than current standard care methods alone.

What evidence suggests that the C4 Program is effective for improving cancer care?

The C4 Program, which participants in this trial may experience, has improved cancer care by helping patients, healthcare teams, and services collaborate more effectively, as studies have shown. Research indicates it enhances communication and connection between patients and doctors. The program also aims to provide educational resources that respect patients' cultural backgrounds, potentially leading to better healthcare experiences. By focusing on patient needs and offering supportive services, the C4 Program strives to make cancer care more patient-centered and effective. Initial findings suggest these improvements can lead to better overall patient outcomes. ^{2 3 4 6 7}

Who Is on the Research Team?

Timothy Mullett, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06326567

Comprehensive Connected Cancer Care (C4): Intervention ... The C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the coordination of ...

2. scholars.uky.edu scholars.uky.edu/en/projects/comprehensive-connected-cancer-care-c4-2/

Comprehensive Connected Cancer Care (C4) - Scholars@UK Disseminate program results to advance best practices for improving the delivery of patient-centered, culturally-sensitive cancer care. Status, Finished.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6375583/

Cancer Care Collaborative Approach to Optimize Clinical ... In 2004, the Clinical Cancer Care Collaborative (C4), a national VA program, was launched to improve timeliness, quality, access improvement, efficiency ...

4. trialx.com trialx.com/clinical-trials/listings/314495/comprehensive-connected-cancer-care-c4-intervention-evaluation/

Comprehensive Connected Cancer Care (C4): Intervention ... The C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves ...

5. uky.trialstoday.org uky.trialstoday.org/trial/NCT06326567

Comprehensive Connected Cancer Care (C4) The C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the ...

6. c4qi.net c4qi.net/

Comprehensive Cancer Center Consortium | Initiatives The C4QI seeks to improve the quality of care for all cancer patients by identifying and promoting best practices that provide optimal clinical outcomes and ...

7. ukhealthcare.uky.edu ukhealthcare.uky.edu/markey-cancer-center/research/csri

Cancer Survivorship Research Initiative - UK HealthCare The Markey Cancer Center Cancer Survivorship Research Initiative helps encourage research focused on the experiences and outcomes of people living with and ...