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Comprehensive Connected Cancer Care (C4): Intervention Evaluation

Comprehensive Connected Cancer Care (C4): Intervention Evaluation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06326567
Enrollment
300
Registered
2024-03-22
Start date
2024-02-01
Completion date
2027-12-01
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Health Care Utilization

Keywords

Community Programs, Health Equity

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.

Interventions

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.

Sponsors

Timothy Mullett
Lead SponsorOTHER
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Health Related Quality of Life (FACT-G7)baseline (enrollment) and 4 monthsThe 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

MeasureTime frameDescription
Overall Survival12 months1 year survival after diagnosis (12 months)

Countries

United States

Contacts

CONTACTYvonne Taul, RN
yvonne.taul@uky.edu859-323-2354
PRINCIPAL_INVESTIGATORTimothy Mullett, MD

University of Kentucky

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026