Clinical trial NCT04602611: Impact Of Nurse Navigation Program on Outcomes in Patients With GI Cancers
Official title: A Randomized, Controlled Prospective Trial Evaluating The Impact Of A Nurse Navigation Program on Patients With Gastrointestinal Cancers Undergoing Oncological Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria

1. Informed consent and HIPAA authorization for the release of personal health information
2. Aged ≥ 18 years at the time of consent
3. Subject is planning to receive their cancer care at LCI at the time of consent
4. 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):

   1. Metastatic/recurrent or locally advanced, unresectable or borderline resectable (as defined per NCCN, Alliance or other acceptable guidelines criteria) pancreatic cancer
   2. Metastatic/recurrent or locally advanced, unresectable esophageal, gastroesophageal junction (GEJ) or gastric cancer patients or those who are not eligible for surgery
   3. 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
   4. 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
   5. 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
5. Ability to read and understand the English or Spanish language
6. 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.
7. Life expectancy is \> 3 months

Exclusion Criteria

1. Subjects have previously received or are currently receiving LCI Patient Navigation Program services
2. Subjects with colorectal cancer enrolled in the Empower Program
3. Subjects with low grade neuroendocrine tumors

Primary outcomes:
measure: Annualized Count of Acute Care Visits
timeFrame: From the date of randomization until subject discontinued the intervention, assessed up to 34 months
measure: Proportion of Participants Surviving at 6 Months
timeFrame: From the date of randomization to death or 6 months
Secondary outcomes:
measure: Proportion of Participants Surviving at 12 Months
timeFrame: From the date of randomization up until 12 months
measure: Hospital Length of Stay
timeFrame: From the date of randomization until subject discontinued the intervention, assessed up to 34 months
measure: Time From Hospice Referral to Death for Participants Referred to Hospice
timeFrame: From the date of hospice referral to death or last follow-up, assessed over 7 months.
measure: Total Number of 30-day Readmissions
timeFrame: From the date of randomization until subject discontinued the intervention, assessed up to 34 months
measure: Proportion of Participants Referred to Supportive Care Services
timeFrame: From the date of randomization until subject discontinued the intervention, assessed up to 34 months
measure: Proportions of Missed Visits of All Scheduled Visits From 0% to 100%.
timeFrame: From the date of randomization until subject discontinued the intervention, assessed up to 34 months
measure: Average Score of Subject Satisfaction as Assessed by an Adaptation of the EORTC PATSAT C33
timeFrame: From the date of randomization up until 14 weeks
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mohamed Salem, MD
role: PRINCIPAL_INVESTIGATOR
References: