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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: CONNECT platform

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).

• Study Type: Interventional
• Enrollment (Estimated): 375
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erika Trapl, PhD; Phone Number: 216-368-0098; Email: erika.trapl@case.edu
• Study Contact Backup: Name: Richard Hoehn; Phone Number: 216-844-8904; Email: Richard.Hoehn@uhhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Case Comprehensive Cancer Center
      • Contact: Erika Trapl, PhD; Phone Number: 216-368-0098; Email: erika.trapl@case.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant improvement as measured by participant distress screening tool	Participant distress screening assessment tool is a list of questionnaire with a scale from 0-10, where 0 is none and 10 is extreme distress	4 months
Quality of life as measured by PHQ-9 Patient Depression Questionnaire	Intepretation for PHQ-9 Patient Depression Questionnaire is based on the final score ranging from 1-27, 1-4 is minimal depression, 5-9 is mild, 10-14 is moderate, 15-19 is moderately severe, 20-27 is severe depression	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of social needs as measured by HRSN(Health related social need) questionnaire	HRSN is a list of 19 questions with multiple choice answers with a scale from 1-5 for each question, where 1 is never and 5 is frequently. A score of 11 or more when numerical values for anwers to questions 6-9 are added shows that the person might not be safe.	4 months
Rate of patient satisfaction as measured by cancer care survey	Patient satisfaction with cancer care survey rate based on a scale from 1-5, where 1 is strongly disagree and 5 is strongly agree	4 months

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Erika Trapl, PhD, Case Western Reserve University, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Patient navigators
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CASE4Z24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As a recipient of Merck Foundation funding, investigators are obligated to collect "harmonized metrics" for program participants. This data is shared back (at the individual level) with the National Program Office. There is no PHI in this dataset, and there is no personal identifying information that is shared. The data is not shared beyond the NPO; all data shared by the NPO is aggregated and not identifiable. Additionally, investigator does not intend to share IPD with anyone outside of the NPO
• IPD Sharing Time Frame: Data is shared with the NPO on a quarterly basis
• IPD Sharing Access Criteria: Data is only shared with the NPO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No