Promoting Access, Resources and Treatment Through Novel and Equitable Solutions for Cancer Care

NCT ID: NCT06481774

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-30
• Study Completion Date: 2027-06-30

Brief Summary

The purpose of this research is to evaluate a novel, integrated approach to providing navigation services to improve cancer outcomes and quality of life.

Detailed Description

In a seminal paper published in 1995, Dr. Harold Freeman proposed that "Patient navigators act as patient advocates for patients with abnormal (Cancer) screening findings."Since that article was published, there has been an extensive literature to support the value of patient navigation services to promote timely and complete receipt of cancer care services for participants newly diagnosed with cancer, as well as along the continuum of cancer treatment, including among underserved populations. Despite this literature, it was not until January 2024 that the Centers for Medicare and Medicaid Services (CMS) formally recognized patient navigation as a reimbursable service in clinical settings. A key value that is attributed to PN services is the ability of navigational processes to improve equitable cancer caner service deliver for participants, irrespective of a person's social determinants of health (SDOHs) composition, including factors like financial stability, educational attainment, access to health care, race/ethnicity, and/or rurality of residence.

In response to the unmet and significant need to reduce disparities in cancer care delivery, in 2022, the Merck Foundation launched a national effort to select 8 grantees across the United States (US) to develop a national, sustainable model to improve equitable cancer care services which, in turn, should help reduce the long-standing, pervasive disparities observed in cancer outcomes for persons of minority race/ethnic status and/or SDOHs. As part of this Alliance, the Case CCC and CWRU PARTNERS study team will develop and examine elements of patient navigational processes that promote timely receipt of cancer care services, more effective patient-provider-systems-level communication around cancer care, while addressing the SDOH needs of participants and ensuring receipt of services after participant referrals ("closed loops"). This project proposes an intentional focus on engaging persons who represent medically disadvantaged or fragile populations (defined here as Greater Cleveland area residents who are Black/African American, Hispanic, and/or reside in a zip code with "high" area deprivation indices).

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patient Navigation Services

Following the consent process, participant will have access to a Patient Navigator, who will serve as a resource for during the time in the study to help navigate and get connected to local resources. The Patient Navigator will keep track of the kinds of support services and referrals provided. The Patient Navigator will contact the participant in 4 months to reassess current needs, quality of life, and areas where additional support is needed.

Group Type: EXPERIMENTAL

CONNECT platform

Intervention Type: BEHAVIORAL

CONNECT platform provides access to participant information across the 5 participant sites to facilitate a more holistic approach to addressing participant needs. It is the use of this cloud-based, HIPAA compliant platform that constitutes the uniqueness of this behavioral intervention.

Interventions

CONNECT platform

CONNECT platform provides access to participant information across the 5 participant sites to facilitate a more holistic approach to addressing participant needs. It is the use of this cloud-based, HIPAA compliant platform that constitutes the uniqueness of this behavioral intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

There are two levels of criteria for inclusion.

• First, investigators will identify individuals who have either had a cancer screening with a suspicious finding (ie. requires diagnostic follow-up) or those individuals who are referred to the UH Seidman Diagnostic Clinic (led by Co-I Hoehn).
• Within that group, investigators will recruit those who identify as African American, Hispanic, or living in a prioritized geography as defined by zip code ADI>=75%ile for state

Exclusion Criteria

• Any participant who is not willing or able to complete an informed consent form will not be eligible for this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erika Trapl, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University, Case Comprehensive Cancer Center

Locations

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erika Trapl, PhD

Role: CONTACT

erika.trapl@case.edu

216-368-0098

Richard Hoehn

Role: CONTACT

Richard.Hoehn@uhhospitals.org

216-844-8904

Facility Contacts

Erika Trapl, PhD

Role: primary

erika.trapl@case.edu

216-368-0098

Other Identifiers

CASE4Z24

Identifier Type: -

Identifier Source: org_study_id