Recruiting

Cancer Care Solutions

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT06481774

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CONNECT platform

Study Details

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

Study ID

NCT06481774

Start date

Jul 30, 2024

Status verified date

Sep, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

375 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Participant improvement as measured by participant distress screening tool [ Time Frame: 4 months ]
  • Quality of life as measured by PHQ-9 Patient Depression Questionnaire [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Erika Trapl, PhD

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

Richard Hoehn

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

Locations

Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Erika Trapl, PhD

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

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Keywords

  • Patient navigators

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2025-09-29.