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

NCT04602611 | Completed Results DMC

• 3 other identifiers: IRB00081349.00046658LCI-GI-NOS-NAV-001
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Proportion of Participants Surviving at 12 Months

  From the date of randomization up until 12 months

• Hospital Length of Stay

  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

  From the date of hospice referral to death or last follow-up, assessed over 7 months.

• Total Number of 30-day Readmissions

  From the date of randomization until subject discontinued the intervention, assessed up to 34 months

• Proportion of Participants Referred to Supportive Care Services

  From the date of randomization until subject discontinued the intervention, assessed up to 34 months

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of Care

Oncology Nurse Navigation

EXPERIMENTAL

Standard of Care + Oncology Nurse Navigation

Other: Oncology Nurse Navigation

Interventions

Oncology Nurse Navigation OTHER

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

Oncology Nurse Navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent and HIPAA authorization for the release of personal health information
• Aged ≥ 18 years at the time of consent
• Subject is planning to receive their cancer care at LCI at the time of consent
• 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):
• Metastatic/recurrent or locally advanced, unresectable or borderline resectable (as defined per NCCN, Alliance or other acceptable guidelines criteria) pancreatic cancer
• Metastatic/recurrent or locally advanced, unresectable esophageal, gastroesophageal junction (GEJ) or gastric cancer patients or those who are not eligible for surgery
• 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
• 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
• Ability to read and understand the English or Spanish language
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: Danielle M Boselli
• Organization: Wake Forest

Danielle.Boselli@AtriumHealth.org

2017903385

Study Officials

• Mohamed Salem, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 26, 2020
• Study Start: November 3, 2020
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)