Comprehensive Connected Cancer Care (C4): Intervention Evaluation

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Health Care Utilization
• Intervention / Treatment: Other: C4 Program

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yvonne Taul, RN; Phone Number: 859-323-2354; Email: yvonne.taul@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University Of Kentucky
      • Contact: Yvonne Taul, RN; Phone Number: 859-323-2354; Email: yvonne.taul@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with newly diagnosed or recurrent cancer who have not initiated treatment of any kind, including surgery, medical management, and/or radiation
• 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).
• Willingness to provide informed consent to participate

Exclusion Criteria:

• Not able to understand and communicate in English
• Unable and/or unwilling to access the internet on a phone, tablet, or computer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline Phase; 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
Experimental: Implementation; 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	Other: C4 Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health Related Quality of Life (FACT-G7)	The FACT-G7 is a 7-item version of the Functional Assessment of Cancer Therapy-General (FACT-G), a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy. The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. Higher scores represent higher quality of life.	baseline (enrollment) and 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	1 year survival after diagnosis (12 months)	12 months

Collaborators and Investigators

• Sponsor: Timothy Mullett
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Timothy Mullett, MD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Health Equity; Community Programs
• Other Study ID Numbers: MCC-23-MULTI-61; 84032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No