Impact Of Nurse Navigation Program on Outcomes in Patients With GI Cancers

Study Overview
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Brief Summary
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The purpose of this study is to learn about the impact of the Oncology Nurse Navigation program on the frequency of Emergency Department, urgent care visits and inpatient hospital admissions; and overall survival rate at 6 months. The investigators aim to understand if prompt and effective coordination of care provided by Oncology Nurse Navigation (ONN) service will reduce the number of avoidable, unplanned ED visits and hospitalizations, as well as adding measurable value to cancer care, and improve patient overall survival.

Detailed Description
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A randomized controlled prospective trial evaluating the effectiveness of a nurse navigation program for gastrointestinal cancer patients undergoing oncological treatment. Upon accrual, patients will be randomized 1:1 to receive standard of care plus ONN service (n = 107) or standard of care only (without ONN service; n = 107). Patients in both arms will be assessed for acute care utilization and overall survival (OS) rate at 6 months. Anticipated accrual period will be 30 months.

Official Title
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A Randomized, Controlled Prospective Trial Evaluating The Impact Of A Nurse Navigation Program on Patients With Gastrointestinal Cancers Undergoing Oncological Treatment

Conditions
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Gastrointestinal Cancer

Intervention / Treatment
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* Other: Oncology Nurse Navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Informed consent and HIPAA authorization for the release of personal health information Aged ≥ 18 years at the time of consent Subject is planning to receive their cancer care at LCI at the time of consent Treatment naïve OR adjuvant greater than 6 months ago, histologically or cytologically confirmed one of the following diagnoses (metastatic/recurrent status can be radiologically confirmed): Metastatic/recurrent or locally advanced, unresectable or borderline resectable (as defined per NCCN, Alliance or other acceptable guidelines criteria) pancreatic cancer Metastatic/recurrent or locally advanced, unresectable esophageal, gastroesophageal junction (GEJ) or gastric cancer patients or those who are not eligible for surgery Metastatic/recurrent or locally advanced, unresectable hepatocellular carcinoma (HCC) radiographic confirmation of the HCC diagnoses is acceptable prior locoregional treatment for subjects with HCC is allowed, but no prior systemic therapy is allowed Metastatic/recurrent or advanced, unresectable biliary cancers (e.g. gall bladder cancer, cholangiocarcinoma) • prior locoregional treatment for subjects with biliary cancers is allowed, but no prior systemic therapy is allowed Metastatic colorectal or small bowel cancer patients who had disease progression on or are intolerant to fluorouracil/capecitabine, oxaliplatin, and irinotecan-based therapy (e.g. FOLFOX, FOLFIRI or FOLFOXIRI) Subjects can be enrolled within, but no later than 30 days after initiation of their systemic therapy, however every effort will be made to enroll subjects prior to the initiation of systemic therapy. Subjects who has completed or undergoing a current palliative radiotherapy are allowed Ability to read and understand the English or Spanish language As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study. However, refusal to complete a patient satisfaction questionnaire IL109 should not refrain a subject from being enrolled. Life expectancy is > 3 months Exclusion Criteria Subjects have previously received or are currently receiving LCI Patient Navigation Program services Subjects with colorectal cancer enrolled in the Empower Program Subjects with low grade neuroendocrine tumors

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Standard of Care | |
| Experimental: Oncology Nurse Navigation<br>Standard of Care + Oncology Nurse Navigation | Other: Oncology Nurse Navigation<br>* Providing the subject with the service of navigation (ONN) performed under LCI Patient Navigation Program (LPNP), led by a registered oncology nurse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Care Utilization | The impact of Oncology Nurse Navigation program on the rate of patient Acute Care Utilization, defined as unplanned inpatient admissions, emergency room encounters, and/or urgent care visits. | From the date of randomization until subject is off-intervention, assessed up to 6 months | 
| Overall Survival | To examine the impact of Oncology Nurse Navigation program on overall survival rate at 6 months. | From the date of randomization until 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncology Nurse Navigation Comparison Overall Survival | Rate of overall survival and overall survival at 12 months | From the date of randomization up until 12 months | 
| Oncology Nurse Navigation Comparison Hospital Stay | Compare the length of hospital stay | From the date of randomization up until 12 months | 
| Oncology Nurse Navigation Comparison Hospice | Time from hospice referral to death | From the date of randomization up until 12 months | 
| Oncology Nurse Navigation Comparison Readmission Rate | Rate of Readmission after 30 days | From the date of randomization up until 12 months | 
| Oncology Nurse Navigation Comparison Referral Rate | Rate of referral to Palliative Care, Hospice, Nutrition Services, and Social Work Services | From the date of randomization up until 12 months | 
| Oncology Nurse Navigation Comparison for Compliance | Rate of adherence to clinical care (the number of no-shows as a percent of all scheduled within Atrium Health, regardless of visit type) | From the date of randomization up until 12 months | 
| Oncology Nurse Navigation Comparison for Satisfaction | Subject satisfaction assessed by a modified European Organization for Research and Treatment of Cancer Patient Satisfaction with cancer care questionnaire #33 (EORTC PATSAT C33). Scale from 1-5; the higher scores indicates a better outcome | From the date of randomization up until 12 months |