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Trial Title:
Effectiveness of Central Oncology Navigation and the Use of an ORN
NCT ID:
NCT06618274
Condition:
Cancer
Malignant Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
navigation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Intervention of oncology research navigator embedded in central oncology navigation
Description:
The intervention of oncology research navigator or Oncology research navigator (ORN) is
embedded in central oncology navigation cancer care delivery.
Arm group label:
Cohort 2
Other name:
oncology research navigator (ORN
Intervention type:
Behavioral
Intervention name:
Central oncology navigation (SOC)
Description:
Central oncology navigation (SOC ) alone.
Arm group label:
Cohort 1
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Contact:
Last name:
Onoshoze Bossey
Phone:
919-445-4941
Email:
onoshoze_bossey@med.unc.edu
Investigator:
Last name:
William Wood, MD
Email:
Principal Investigator
Start date:
December 2024
Completion date:
July 1, 2031
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06618274
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
