Impact Of Nurse Navigation Program on Outcomes in Patients With GI Cancers
- Conditions
- Gastrointestinal Cancer
- Interventions
- Other: Oncology Nurse Navigation
- Registration Number
- NCT04602611
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oncology Nurse Navigation Oncology Nurse Navigation Standard of Care + Oncology Nurse Navigation
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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 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 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 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
Trial Locations
- Locations (1)
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States