Comprehensive Connected Cancer Care (C4): Intervention Evaluation

Cancer Clinical Trial

Official title:

Comprehensive Connected Cancer Care (C4): Intervention Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326567
• Other study ID #: 84032
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: University of Kentucky
• Contact: Yvonne Taul, RN
• Phone: 859-323-2354
• Email: yvonne.taul[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Health Care Utilization

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Timothy Mullett	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival	1 year survival after diagnosis (12 months)	12 months