Comprehensive Connected Cancer Care (C4): Intervention Evaluation

Timothy Mullett

Status: Enrolling

Conditions: Cancer; Health Care Utilization

Treatments: Other: C4 Program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06326567

84032

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Baseline Phase

No Intervention group

Description:

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

Implementation

Experimental group

Description:

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

Treatment:

Other: C4 Program