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Recruiting

NCT Number: NCT06326567

Comprehensive Connected Cancer Care (C4): Intervention Evaluation

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.

Recruiting

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Key information

Conditions

Cancer Behavior Health Behavior Health Care Utilization Neoplasms Patient Acceptance of Health Care Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location status: Recruiting

Location contact

Yvonne Taul, RN

CONTACT

[email protected]

859-323-2354

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C4 Program

Other

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 outcomes

  1. Change in Health Related Quality of Life (FACT-G7)

    Time frame: 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 outcomes

  1. Overall Survival

    Time frame: 12 months

    1 year survival after diagnosis (12 months)

Study contacts

Contact information is provided by the study sponsor or research team.

Yvonne Taul, RN

CONTACT

[email protected]

859-323-2354

Sponsors and collaborators

Lead sponsor

Timothy Mullett

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 22, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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