ACCESS: Impact Of Nurse Navigation Program on Outcomes in Patients With GI Cancers
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Standard of Care Standard of Care |
|
| Experimental: Oncology Nurse Navigation Standard of Care + Oncology Nurse Navigation |
Other: Oncology Nurse Navigation
Providing the subject with the service of navigation (ONN) performed under LCI Patient Navigation Program (LPNP), led by a registered oncology nurse.
|
Outcome Measures
Primary Outcome Measures
- Acute Care Utilization [From the date of randomization until subject is off-intervention, assessed up to 6 months]
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.
- Overall Survival [From the date of randomization until 6 months]
To examine the impact of Oncology Nurse Navigation program on overall survival rate at 6 months.
Secondary Outcome Measures
- Oncology Nurse Navigation Comparison Overall Survival [From the date of randomization up until 12 months]
Rate of overall survival and overall survival at 12 months
- Oncology Nurse Navigation Comparison Hospital Stay [From the date of randomization up until 12 months]
Compare the length of hospital stay
- Oncology Nurse Navigation Comparison Hospice [From the date of randomization up until 12 months]
Time from hospice referral to death
- Oncology Nurse Navigation Comparison Readmission Rate [From the date of randomization up until 12 months]
Rate of Readmission after 30 days
- Oncology Nurse Navigation Comparison Referral Rate [From the date of randomization up until 12 months]
Rate of referral to Palliative Care, Hospice, Nutrition Services, and Social Work Services
- Oncology Nurse Navigation Comparison for Compliance [From the date of randomization up until 12 months]
Rate of adherence to clinical care (the number of no-shows as a percent of all scheduled within Atrium Health, regardless of visit type)
- Oncology Nurse Navigation Comparison for Satisfaction [From the date of randomization up until 12 months]
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
Other Outcome Measures
- Oncology Nurse Navigation Provider Comparison for Outcomes [From the date of randomization until 6 months]
Outcome comparison for subjects within the ONN arm for subjects navigated by GI specialists versus subjects navigated by general oncology nurse navigators
Eligibility Criteria
Criteria
Inclusion Criteria
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Capable of providing written informed consent and HIPAA authorization for the release of personal health information
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Aged ≥ 18 years at the time of consent
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Subject is planning to receive their cancer care at LCI at the time of consent
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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):
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Metastatic/recurrent or locally advanced, unresectable or borderline resectable (as defined per NCCN, Alliance or other acceptable guidelines criteria) pancreatic cancer
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Metastatic/recurrent or locally advanced, unresectable esophageal, gastroesophageal junction (GEJ) or gastric cancer patients or those who are not eligible for surgery
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Metastatic/recurrent or locally advanced, unresectable hepatocellular carcinoma (HCC)
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radiographic confirmation of the HCC diagnoses is acceptable
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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
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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.
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Life expectancy is > 3 months
Exclusion Criteria
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Subjects have previously received or are currently receiving LCI Patient Navigation Program services
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Subjects with low grade neuroendocrine tumors
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Levine Cancer Institute | Charlotte | North Carolina | United States | 28204 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Mohamed Salem, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00081349.
- 00046658
- LCI-GI-NOS-NAV-001