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

NCT06481774 | Recruiting DMC

• 1 other identifier: CASE4Z24
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Patient navigators

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The number of social needs as measured by HRSN(Health related social need) questionnaire

  4 months

• Rate of patient satisfaction as measured by cancer care survey

  4 months

Study Arms (1)

Patient Navigation Services

EXPERIMENTAL

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

Interventions

CONNECT platform 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.

Patient Navigation Services

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Erika Trapl, PhD

  Case Western Reserve University, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erika Trapl, PhD

CONTACT

216-368-0098; erika.trapl@case.edu

Richard Hoehn

CONTACT

216-844-8904; Richard.Hoehn@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 1, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data is shared with the NPO on a quarterly basis
• Access Criteria: Data is only shared with the NPO

Locations

US (1)