Effectiveness of Central Oncology Navigation and the Use of an ORN
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention of oncology research navigator embedded in central oncology navigation, Central oncology navigation (SOC).
- Who it may be relevant to
- Registry conditions: Cancer, Malignant Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Navigation and Research: Evaluating the Intervention of Central Navigation and an Oncology Research Navigator (ORN) on Cancer Outcomes and Clinical Trial Enrollment (NAVIGATE Trial)
Overview
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.
Interventions
- Behavioral 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. - Behavioral Central oncology navigation (SOC)
Central oncology navigation (SOC ) alone.
Primary outcome measures
- Cohort 1-supportive service offered [Time frame: Up to 6 months]
- Cohort 2: number of patients enrolled [Time frame: Up to 6 months]
Secondary outcome measures (6)
- Cohort 1: Health-related quality of life [Time frame: Baseline and 3 months]
- Cohort 1: Patient activation [Time frame: Baseline and 3 months]
- Cohort 1: Patient experience [Time frame: Baseline and 3 months]
- Cohort 1: Net promoter [Time frame: Baseline and 3 months]
- Cohort 1: Overall Survival [Time frame: Up to 5 years]
- Cohort 2: Health-related quality of life [Time frame: Baseline and 3 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill
Identifiers
NCT: NCT06618274 · LCCC2334