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

Gastrointestinal Cancer Clinical Trial

— ACCESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602611
• Other study ID #: IRB00081349.
• Secondary ID: 00046658LCI-GI-N
• Status: Completed
• Phase: N/A
• Start date: November 3, 2020
• Est. completion date: August 10, 2023

Study information

• Verified date: December 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Acute Care Utilization	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.	From the date of randomization until subject is off-intervention, assessed up to 6 months
Primary	Overall Survival	To examine the impact of Oncology Nurse Navigation program on overall survival rate at 6 months.	From the date of randomization until 6 months
Secondary	Oncology Nurse Navigation Comparison Overall Survival	Rate of overall survival and overall survival at 12 months	From the date of randomization up until 12 months
Secondary	Oncology Nurse Navigation Comparison Hospital Stay	Compare the length of hospital stay	From the date of randomization up until 12 months
Secondary	Oncology Nurse Navigation Comparison Hospice	Time from hospice referral to death	From the date of randomization up until 12 months
Secondary	Oncology Nurse Navigation Comparison Readmission Rate	Rate of Readmission after 30 days	From the date of randomization up until 12 months
Secondary	Oncology Nurse Navigation Comparison Referral Rate	Rate of referral to Palliative Care, Hospice, Nutrition Services, and Social Work Services	From the date of randomization up until 12 months
Secondary	Oncology Nurse Navigation Comparison for Compliance	Rate of adherence to clinical care (the number of no-shows as a percent of all scheduled within Atrium Health, regardless of visit type)	From the date of randomization up until 12 months
Secondary	Oncology Nurse Navigation Comparison for Satisfaction	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	From the date of randomization up until 12 months