Comprehensive Connected Cancer Care (C4): Intervention Evaluation

Not Applicable

Recruiting

• Conditions: Cancer; Health Care Utilization
• Interventions: Other: C4 Program

• Registration Number: NCT06326567
• Lead Sponsor: Timothy Mullett

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Primary Completion: 2027-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implementation	C4 Program	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

Primary Outcome Measures

Name	Time	Method
Change in Health Related Quality of Life (FACT-G7)	baseline (enrollment) and 4 months	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	12 months	1 year survival after diagnosis (12 months)

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States