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NCT06618274 | NOT YET RECRUITING | Cancer

Effectiveness of Central Oncology Navigation and the Use of an ORN
Sponsor:

UNC Lineberger Comprehensive Cancer Center

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.

Condition or disease

Cancer

Malignant Tumor

Intervention/treatment

Intervention of oncology research navigator embedded in central oncology navigation

Central oncology navigation (SOC)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 686 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Evaluating the Effectiveness of Central Oncology Navigation and the Use of an Oncology Research Navigator
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2027-01-10
Estimated Study Completion Date : 2031-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Effectiveness of Central Oncology Navigation and the Use of an ORN

Location Details

NCT06618274

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, North Carolina

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27599