RECRUITING

Effectiveness of Central Oncology Navigation and the Use of an ORN

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluating the Effectiveness of Central Oncology Navigation and the Use of an Oncology Research Navigator

Quick Facts

Study Start:2025-03-03
Study Completion:2031-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06618274

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  2. * Subject is willing and able to comply with study activities based on the judgement of the investigator.
  3. * Age ≥ 18 years at the time of consent.
  4. * Subject has a new patient appointment for cancer care at a UNC Medical Center and a confirmed cancer diagnosis.
  1. * Lack of internet access.
  2. * Inability to understand the English language.
  3. * Psychological or other disability resulting in the inability to provide informed consent.

Contacts and Locations

Study Contact

Mireille Leone
CONTACT
919-445-0768
Mireille_Leone@med.unc.edu
Onoshoze Bossey
CONTACT
(919)-445-4941
obossey@email.unc.edu

Principal Investigator

William A Wood, MD
PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • William A Wood, MD, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-03
Study Completion Date2031-07-01

Study Record Updates

Study Start Date2025-03-03
Study Completion Date2031-07-01

Terms related to this study

Keywords Provided by Researchers

  • navigation

Additional Relevant MeSH Terms

  • Cancer
  • Malignant Tumor