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Implementation for Cancer

N/A
Recruiting
Led By Timothy Mullett, MD
Research Sponsored by Timothy Mullett
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial aims to improve patient care by providing a comprehensive program that includes coordination of care, better communication between patients and healthcare providers, and access to supportive services. The program involves patient navigation, digital needs

Who is the study for?
The C4 trial is for individuals utilizing healthcare services for cancer treatment. Participants should be willing to engage with a multi-level intervention program that includes patient navigation, digital tools for needs assessment and referrals, as well as educational resources.Check my eligibility
What is being tested?
This trial evaluates the C4 Program, which focuses on improving care coordination between patients and various healthcare providers through digital assessments and patient navigation. It also aims to enhance communication skills within healthcare teams and provide culturally appropriate education to patients.See study design
What are the potential side effects?
Since this trial involves non-medical interventions focused on care coordination and support systems rather than drugs or medical procedures, traditional side effects are not applicable. However, participants may experience changes in their health care utilization patterns.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Health Related Quality of Life (FACT-G7)
Secondary outcome measures
Overall Survival

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ImplementationExperimental Treatment1 Intervention
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
Group II: Baseline PhaseActive Control1 Intervention
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

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Who is running the clinical trial?

Timothy MullettLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,846 Total Patients Enrolled
Timothy Mullett, MDPrincipal InvestigatorUniversity of Kentucky

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for participants currently open in this clinical trial?

"As per clinicaltrials.gov, this current trial is actively pursuing volunteers. The study was first listed on 2/1/2024 and the most recent update was made on 3/15/2024."

Answered by AI

What is the current number of individuals receiving medical care as part of this clinical trial?

"Affirmative. The information available on clinicaltrials.gov confirms the ongoing recruitment efforts for this research investigation. This study was first listed on February 1, 2024, with its most recent update recorded on March 15, 2024. Recruitment aims to enroll a total of 300 participants at a single designated site."

Answered by AI
~200 spots leftby Jun 2025