Comprehensive Connected Cancer Care (C4): Intervention Evaluation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTimothy Mullett
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Not able to understand and communicate in English
Unable and/or unwilling to access the internet on a phone, tablet, or computer
Trial design
Design model
Parallel
Treatments tested in this trial
C4 Program
Other interventionC4 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Baseline PhaseNo intervention 0 interventions
Group B: ImplementationExperimental treatment 1 intervention
Trial outcomes
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 monthsSecondary outcomes
1
Overall Survival
1 year survival after diagnosis (12 months)
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Timothy Mullett
Lead sponsor
University of Kentucky
Sponsor institution
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov