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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Cancer
• Intervention / Treatment: Other: Oncology Nurse Navigation

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 Type: Interventional
• Enrollment (Actual): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Count of Acute Care Visits	The annualized count of acute care visits, where acute care visits included all unplanned inpatient admissions, emergency room encounters, and/or urgent care visits, was calculated for each subject as the total number of acute care visits normalized to an annual basis.	From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Proportion of Participants Surviving at 6 Months	The proportion of participants surviving at 6 months was calculated for each treatment arm. Six-month overall survival was determined for each subject as a binary variable indicating whether or not the subject was alive at 6 months after study enrollment. Failure occurred if the subject died from any cause within 6 months of study enrollment. The proportions were compared between the arms.	From the date of randomization to death or 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Surviving at 12 Months	The proportion of participants surviving at 12 months was calculated for each treatment arm. Six-month overall survival was determined for each subject as a binary variable indicating whether or not the subject was alive at 12 months after study enrollment. Failure occurred if the subject died from any cause within 12 months of study enrollment. The proportions were compared between the arms.	From the date of randomization up until 12 months
Hospital Length of Stay	Hospital length of stay was calculated for each subject as the total number of unplanned inpatient days while on intervention.	From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Time From Hospice Referral to Death for Participants Referred to Hospice	Time from hospice referral to death was a time-to-event endpoint defined as the time from hospice referral to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive. This endpoint was only calculated for subjects referred to hospice.	From the date of hospice referral to death or last follow-up, assessed over 7 months.
Total Number of 30-day Readmissions	The number of readmissions within 30 days of in-patient admission discharges was calculated for each participant. This outcome was derived for each subject with at least one in-patient admission.	From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Proportion of Participants Referred to Supportive Care Services	Referral to Supportive Care Services was derived for each participant as a binary variable indicating if there was at least one documented referral to Palliative Care, Nutrition Services, and/or Social Work Services.	From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Proportions of Missed Visits of All Scheduled Visits From 0% to 100%.	This proportion was calculated for each participant as the percentage of missed visits of all scheduled within Atrium Health, regardless of visit type.	From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Average Score of Subject Satisfaction as Assessed by an Adaptation of the EORTC PATSAT C33	Subject satisfaction was assessed by a modified European Organization for Research and Treatment of Cancer Patient Satisfaction with cancer care questionnaire #33 (EORTC PATSAT C33) 10-14 weeks after randomization. Subjects completed the questionnaire assessing thirty-four elements of their experience with regards to hospital environment, hospital personnel, and treatment. Each question was assessed on a Likert-type scale ranging Poor to Excellent (mapped numerically to 1-5), where the higher scores indicated a better experience. The average score was calculated for each subject as the sum of the non-missing standardized scores divided by the number of measures contributing to the sum. The average score could range from 1 (the minimum) to 5 (the maximum).	From the date of randomization up until 14 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oncology Nurse Navigation Provider Comparison for Outcomes	Outcome comparison for subjects within the ONN arm for subjects navigated by GI specialists versus subjects navigated by general oncology nurse navigators	From the date of randomization until 6 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Mohamed Salem, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: IRB00081349.; 00046658; LCI-GI-NOS-NAV-001 (Other Identifier: Atrium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No