Clinical trial NCT06481774: Promoting Access, Resources and Treatment Through Novel and Equitable Solutions for Cancer Care
Official title: PARTNERS: Promoting Access, Resources and Treatment Through Novel and Equitable Solutions for Cancer Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Patient navigators
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Participant improvement as measured by participant distress screening tool
timeFrame: 4 months
measure: Quality of life as measured by PHQ-9 Patient Depression Questionnaire
timeFrame: 4 months
Secondary outcomes:
measure: The number of social needs as measured by HRSN(Health related social need) questionnaire
timeFrame: 4 months
measure: Rate of patient satisfaction as measured by cancer care survey
timeFrame: 4 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University, Case Comprehensive Cancer Center
name: Erika Trapl, PhD
role: PRINCIPAL_INVESTIGATOR
References: