Comprehensive Connected Cancer Care (C4): Intervention Evaluation

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Timothy Mullett
Study ID
NCT06326567
Status
Recruiting
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Conditions

  • Cancer
  • Health Care Utilization

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
Apr 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Yvonne Taul, RN
[email protected]
859-323-2354

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By research site
University of Kentucky· Lexington, KY

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