Effectiveness of Central Oncology Navigation and the Use of an ORN

NCT06618274 | Recruiting DMC

• 1 other identifier: LCCC2334
• Study Type: interventional
• Target: 686
• Locations: 1 country
• Sites: 1

Brief Summary

This health services interventional study investigates the effectiveness of central oncology navigation (SOC ) alone and central oncology navigation with a new role called an "oncology research navigator (ORN)" who is embedded in central oncology navigation cancer care delivery. This study will examine two patient cohorts: Cohort 1 will enroll patients with new cancer appointments within genitourinary (GU) or thoracic cancers. These clinics have not yet implemented the central navigation program. Participants will be enrolled pre- and post-implementation of the central oncology navigator within these cancer groups to evaluate the effectiveness of the central oncology navigator alone. The second cohort will enroll participants with new cancer appointments within gastrointestinal (GI), hematology, and breast cancer (clinics where the central navigation program was implemented). These individuals will be randomized to receive standard of care, which for these cancer types includes central oncology navigation or the intervention of an oncology research navigator in addition to SOC. This intervention will involve baseline and biweekly follow-up for a total of 3 months. Interactions with the ORN will include facilitating participation in supportive care services and clinical trials. All participants will undergo baseline and follow-up patient-reported outcomes and data collection. The study will evaluate the impact of the central oncology navigation program alone, as well as the addition of the ORN on patient quality of life, as well as enrollment into studies and participation in supportive care services. Additional analyses will evaluate the impact of the central oncology navigation program on patient experience, patient activation, net promoter scores, and overall survival.

Conditions

Cancer; Malignant Tumor

Keywords

navigation

Outcome Measures

Primary Outcomes (2)

• Cohort 1-supportive service offered

  Participation in at least 1 supportive service offered will be measured by the number of patients receiving services. This information will be gathered from chart review.

  Up to 6 months

• Cohort 2: number of patients enrolled

  Enrollment into non-treatment clinical studies will be measured by the number of patients enrolled at any time. This information will be gathered from chart review.

  Up to 6 months

Secondary Outcomes (6)

• Cohort 1: Health-related quality of life

  Baseline and 3 months

• Cohort 1: Patient activation

  Baseline and 3 months

• Cohort 1: Patient experience

  Baseline and 3 months

• Cohort 1: Net promoter

  Baseline and 3 months

• Cohort 1: Overall Survival

  Up to 5 years

Study Arms (2)

Cohort 1

EXPERIMENTAL

Cohort 1 will enroll patients with new cancer appointments within genitourinary (GU) or thoracic cancers. These clinics have not yet implemented the central navigation program.

Behavioral: Central oncology navigation (SOC)

Cohort 2

EXPERIMENTAL

Cohort 2 will enroll participants with new cancer appointments within gastrointestinal (GI), hematology, and breast cancer (clinics where the central navigation program was implemented). These individuals will be randomized to receive standard of care, which for these cancer types includes central oncology navigation or the intervention of oncology research navigator in addition to SOC.

Behavioral: Intervention of oncology research navigator embedded in central oncology navigation

Interventions

Intervention of oncology research navigator embedded in central oncology navigation BEHAVIORAL

The intervention of oncology research navigator or Oncology research navigator (ORN) is embedded in central oncology navigation cancer care delivery.

Also known as: oncology research navigator (ORN

Cohort 2

Central oncology navigation (SOC) BEHAVIORAL

Central oncology navigation (SOC ) alone.

Cohort 1

Eligibility Criteria

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

You may qualify if:

• In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
• Informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
• Subject is willing and able to comply with study activities based on the judgement of the investigator.
• Age ≥ 18 years at the time of consent.
• Subject has a new patient appointment for cancer care at a UNC Medical Center and a confirmed cancer diagnosis.

You may not qualify if:

• Lack of internet access.
• Inability to understand the English language.
• Psychological or other disability resulting in the inability to provide informed consent.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Neoplasms

Study Officials

• William A Wood, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mireille Leone

CONTACT

919-445-0768; Mireille_Leone@med.unc.edu

Allison Ross

CONTACT

(919)-445-4941; Allison_Ross@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: March 3, 2025
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): July 1, 2031
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)