Recruiting

Observational Study

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06618274

Conditions

Cancer

Malignant Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intervention of oncology research navigator embedded in central oncology navigation

Central oncology navigation (SOC)

Study Details

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

Study ID

NCT06618274

Start date

Mar 3, 2025

Status verified date

Jan, 2026

Completion date

Jul 1, 2031

Anticipated

Primary completion date

Jan 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Design

Enrollment

686 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

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.

experimental: Cohort 2

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.

Interventions

Intervention of oncology research navigator embedded in central oncology navigation

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

Central oncology navigation (SOC)

Central oncology navigation (SOC ) alone.

Primary outcome measure

  • Cohort 1-supportive service offered [ Time Frame: Up to 6 months ]
  • Cohort 2: number of patients enrolled [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Locations

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

William Wood, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Keywords

  • navigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-01-28.