CancerNCT06618274
Effectiveness of Central Oncology Navigation and the Use of an ORN
A study testing Intervention of oncology research navigator embedded in central oncology navigation and Central oncology navigation (SOC) in people with Cancer and Malignant Tumor, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Malignant Tumor
- What is being tested?
- Intervention of oncology research navigator embedded in central oncology navigation and Central oncology navigation (SOC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 686 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2025to 1 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Lack of internet access.
- Inability to understand the English language.
- Psychological or other disability resulting in the inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Onoshoze Bossey, 919-445-4941, onoshoze_bossey@med.unc.edu
William Wood, MD
About this study
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)
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.
- Conditions
- Cancer, Malignant Tumor
- Being tested
- Intervention of oncology research navigator embedded in central oncology navigation, Central oncology navigation (SOC)
- Keywords
- navigation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention of oncology research navigator embedded in central oncology navigationBehavioural
Also called oncology research navigator (ORN
The intervention of oncology research navigator or Oncology research navigator (ORN) is embedded in central oncology navigation cancer care delivery.
Central oncology navigation (SOC)Behavioural
Central oncology navigation (SOC ) alone.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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. Receives: Behavioral: Central oncology navigation (SOC) |
| Cohort 2 | Experimental | 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. Receives: Behavioral: Intervention of oncology research navigator embedded in central oncology navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 6 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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")
Measured: 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?"
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start3 Mar 2025
- Primary completion10 Jan 2027 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 686 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William A Wood, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618274
- Sponsor's protocol ID
- LCCC2334
- Status last verified
- Jan 2026
- First submitted
- 25 Sep 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06618274
- Acronym / sponsor ID
- LCCC2334
- Conditions
- Cancer, Malignant Tumor
- Keywords
- navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 686 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Behavioral: Central oncology navigation (SOC)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. |
| Cohort 2 | Experimental | Behavioral: Intervention of oncology research navigator embedded in central oncology navigationCohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Lack of internet access.
- Inability to understand the English language.
- Psychological or other disability resulting in the inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention of oncology research navigator embedded in central oncology navigationAlso: oncology research navigator (ORNThe intervention of oncology research navigator or Oncology research navigator (ORN) is embedded in central oncology navigation cancer care delivery. | Behavioural | Cohort 2 |
| Central oncology navigation (SOC)Central oncology navigation (SOC ) alone. | Behavioural | Cohort 1 |
Primary outcome
Cohort 1-supportive service offered
Time frame: Up to 6 months
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.
Cohort 2: number of patients enrolled
Time frame: Up to 6 months
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William A Wood, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention of oncology research navigator embedded in central oncology navigation and Central oncology navigation (SOC) in people with Cancer and Malignant Tumor, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mireille Leone (919-445-0768, Mireille_Leone@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1-supportive service offered (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.