Recruiting

Observational Study

Sponsor:

Timothy Mullett

Code:

NCT06326567

Conditions

Cancer

Health Care Utilization

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

C4 Program

Study Details

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.

Conditions

Cancer

Health Care Utilization

Study ID

NCT06326567

Start date

Feb 1, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

Interventions

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.

Primary outcome measure

  • Change in Health Related Quality of Life (FACT-G7) [ Time Frame: baseline (enrollment) and 4 months ]

Central Contacts and Locations

Central contacts

Yvonne Taul, RN

859-323-2354yvonne.taul@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Yvonne Taul, RN

859-323-2354Yvonne.Taul@uky.edu

More Information

Sponsor

Timothy Mullett

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Community Programs
  • Health Equity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Timothy Mullett on 2026-06-22.