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

NCT ID: NCT04602611

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-03
• Study Completion Date: 2023-08-10

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.

Conditions

Gastrointestinal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Oncology Nurse Navigation

Standard of Care + Oncology Nurse Navigation

Group Type: EXPERIMENTAL

Oncology Nurse Navigation

Intervention Type: OTHER

Providing the subject with the service of navigation (ONN) performed under LCI Patient Navigation Program (LPNP), led by a registered oncology nurse.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed Salem, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Levine Cancer Institute

Charlotte, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

00046658

Identifier Type: -

Identifier Source: secondary_id

LCI-GI-NOS-NAV-001

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00081349.

Identifier Type: -

Identifier Source: org_study_id