Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06326567

Comprehensive Connected Cancer Care (C4) Intervention Evaluation to Improve Patient-Centered Cancer Care

Led by Timothy Mullett · Updated on 2025-04-06

300

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

T

Timothy Mullett

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the Comprehensive Connected Cancer Care (C4) program, which is designed to improve care coordination, patient communication, and supportive services for people with cancer. This program focuses on helping patients, healthcare teams, and healthcare systems work better together by using patient navigation, digital tools, and culturally appropriate educational resources. The study aims to see how these efforts affect patient-centered care and health outcomes for cancer patients. The study includes two phases: an 18-month Baseline Phase where patients receive usual care and data is collected, followed by an Implementation Phase where the C4 program is introduced. During the Implementation Phase, newly diagnosed cancer patients (not from the Baseline Phase) will be enrolled and the same data will be collected for comparison. The program offers patient navigation, digital needs assessments, referral systems, and healthcare team training to enhance communication and engagement. Participants will be asked to complete surveys and their electronic health records will be reviewed to assess outcomes such as health-related quality of life over four months and overall survival at 12 months. The study collects data on patient experiences, healthcare use, and supportive services to evaluate the program's effect. The total participation involves multiple months of follow-up and data collection to monitor these outcomes and support patient-centered care improvements.

CONDITIONS

Brief Title

Comprehensive Connected Cancer Care (C4): Intervention Evaluation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with newly diagnosed or recurrent cancer who have not started any treatment
  • Patients with at least one social determinant of health need or at high risk based on race, ethnicity, or insurance status
  • Willingness to provide informed consent to participate
Not Eligible

You will not qualify if you...

  • Unable to understand or communicate in English
  • Unable or unwilling to access the internet using a phone, tablet, or computer

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Baseline Phase

Duration - 18 months

Participants are observed during a period of usual care before the intervention is introduced. Data are collected via patient surveys and electronic health record abstraction.

Data collection over 4 months for most outcomes and 12 months for overall survival

Implementation

Duration - Duration concurrent with observation period after baseline phase

Participants receive the C4 Program intervention which includes patient navigation, communication skills training for healthcare teams, and access to supportive services. Data collection continues as in the baseline phase.

Data collection at baseline and 4 months, with overall survival assessed at 12 months

Trial Site Locations

Total: 1 location

1

University of Kentucky

Lexington, Kentucky, United States, 40506

Actively Recruiting

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Research Team

Y

Yvonne Taul, RN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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