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Clinical Trial NCT06618274 for Cancer, Malignant Tumor is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effectiveness of Central Oncology Navigation and the Use of an ORN 686 Randomized Overall Survival
Clinical Trial NCT06618274 is an interventional study for Cancer, Malignant Tumor that is recruiting. It started on 3 March 2025 with plans to enroll 686 participants. Led by UNC Lineberger Comprehensive Cancer Center, it is expected to complete by 1 July 2031. The latest data from ClinicalTrials.gov was last updated on 28 January 2026.
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 thoraci...Show More
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)
Conditions
CancerMalignant TumorOther Study IDs
- LCCC2334
NCT ID Number
Start Date (Actual)
2025-03-03
Last Update Posted
2026-01-28
Completion Date (Estimated)
2031-07-01
Enrollment (Estimated)
686
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
navigation
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCohort 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. | Central oncology navigation (SOC) Central oncology navigation (SOC ) alone. |
ExperimentalCohort 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. | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Cohort 1-supportive service offered | Participation in at least 1 supportive service offered will be measured by the number of patients receiving services. This information will be gathered from chart review. | Up to 6 months |
Cohort 2: number of patients enrolled | Enrollment into non-treatment clinical studies will be measured by the number of patients enrolled at any time. This information will be gathered from chart review. | Up to 6 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Cohort 1: Health-related quality of life | Cohort 1: Health-related quality of life will be measured using the PROMIS Global Health. The PROMIS Global Health is a comprehensive tool designed to assess an individual's overall physical, mental, and social health and includes 10 items that cover various health domains. These items are divided into two main components: Global Physical Health and Global Mental Health. Global Physical Health: This includes items related to physical functioning, pain, fatigue, and overall physical health. Global Mental Health: This includes items related to mental health, emotional distress, and social health.Response Options: Each item is rated on a 5-point Likert scale, with higher scores indicating better health.Raw Scores: The responses are summed to create raw scores for both the Global Physical Health and Global Mental Health components. | Baseline and 3 months |
Cohort 1: Patient activation | Cohort 1: Patient activation will be measured using Patient Activation Measure -13 (PAM-13). PAM-13 is a validated questionnaire designed to assess an individual's knowledge, skills, and confidence in managing their own health and healthcare. It consists of 13 items that measure patient activation, which is the extent to which individuals feel capable of managing their health. The PAM 13 includes 13 statements that respondents rate based on their level of agreement, ranging from "Strongly Disagree" to "Strongly Agree." Responses are scored on a scale from 0 to 100. Higher scores indicate greater patient activation. | Baseline and 3 months |
Cohort 1: Patient experience | Cohort 1: Patient experience will be measured using the Consumer Assessment of Healthcare Providers and Systems (CAHPs) cancer care survey. Scoring will be any number from 0 to 10, where 0 is the worst cancer care team possible and 10 is the best cancer care team possible, what number would you use to rate your cancer care team? (0-10 rating, from "worst cancer care team possible" to "best cancer care team possible" 2. Considering all your cancer care at this cancer center, using any number from 0 to 10, where 0 is the worst overall cancer care experience possible and 10 is the best overall cancer care experience possible, what number would you use to rate your overall cancer care experience? (0-10 rating, from "worst overall cancer care experience possible" to "best overall cancer care experience possible") | Baseline and 3 months |
Cohort 1: Net promoter | Cohort 1: Net promoter scores will be measured using the net promoter score survey.
The Net Promoter Score (NPS) is used as a metric for assessing customer loyalty and satisfaction. NPS measures the likelihood of customers to recommend a company's product or service to others. It is based on a single question: "On a scale from 0 to 10, how likely are you to recommend our product/service to a friend or colleague?" | Baseline and 3 months |
Cohort 1: Overall Survival | Cohort 1: Overall Survival, defined as death by any cause from the time of enrollment will be measured. Any patient who has not died by the analysis date will be censored. Sub-analyses for cancer types will be conducted. | Up to 5 years |
Cohort 2: Health-related quality of life | Cohort 2: Health-related quality of life will be measured using the PROMIS Global Health 10-item instrument in all participants The PROMIS Global Health is a comprehensive tool designed to assess an individual's overall physical, mental, and social health and includes 10 items that cover various health domains. These items are divided into two main components: Global Physical Health and Global Mental Health. Global Physical Health: This includes items related to physical functioning, pain, fatigue, and overall physical health. Global Mental Health: This includes items related to mental health, emotional distress, and social health.Response Options: Each item is rated on a 5-point Likert scale, with higher scores indicating better health.Raw Scores: The responses are summed to create raw scores for both the Global Physical Health and Global Mental Health components. | Baseline and 3 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
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.
- Lack of internet access.
- Inability to understand the English language.
- Psychological or other disability resulting in the inability to provide informed consent.
Study Central Contact
Contact: Mireille Leone, 919-445-0768, [email protected]
Contact: Allison Ross, (919)-445-4941, [email protected]
1 Study Locations in 1 Countries
North Carolina
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, 27599, United States
Onoshoze Bossey, Contact, 919-445-4941, [email protected]
William Wood, MD, Principal Investigator
Recruiting