CClinicalTrials.gg
RecruitingNCT06326567Updated Jun 22, 2026

Comprehensive Connected Cancer Care (C4): Intervention Evaluation

An interventional study of C4 Program in Cancer and Health Care Utilization, sponsored by Timothy Mullett. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by Timothy Mullett · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer
  • Health Care Utilization

Keywords

  • Community Programs
  • Health Equity
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 300 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Timothy Mullett is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Not able to understand and communicate in English
  • Unable and/or unwilling to access the internet on a phone, tablet, or computer
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study 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

    Other: C4 Program

Interventions

  • OtherC4 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline (enrollment) and 4 months

Secondary outcomes

  1. Overall Survival

    1 year survival after diagnosis (12 months)

    Time frame: 12 months

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Study locations

1 of 1 sites recruiting
  • University of Kentucky
    Lexington, Kentucky 40506, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06326567
Lead sponsor
Timothy Mullett
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Timothy Mullett (Professor, University of Kentucky) — Sponsor-investigator
First posted
Mar 22, 2024
Start date
Feb 1, 2024
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 22, 2026

Study contacts

Yvonne Taul, RN
Contact
yvonne.taul@uky.edu
859-323-2354
Timothy Mullett, MD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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