NCT04602611: ACCESS

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

Completed NA Results posted Last updated 30 January 2025

What this trial tests

NA trial testing Oncology Nurse Navigation in Gastrointestinal Cancer in 228 participants. Completed in 10 August 2023.

Timeline

3 November 2020

Primary endpoint
10 August 2023

10 August 2023

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	228
Start date	3 November 2020
Primary completion	10 August 2023
Estimated completion	10 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Oncology Nurse Navigation

Conditions studied

• Gastrointestinal Cancer — all drugs for Gastrointestinal Cancer →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Gastrointestinal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Annualized Count of Acute Care Visits Primary · From the date of randomization until subject discontinued the intervention, assessed up to 34 months

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.

Group	Value	95% CI
Standard of Care	3	0 – 9.6
Oncology Nurse Navigation	3.8	1.3 – 7.7

Proportion of Participants Surviving at 6 Months Primary · From the date of randomization to death or 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.

Group	Value	95% CI
Standard of Care	52
Oncology Nurse Navigation	58

Proportion of Participants Surviving at 12 Months Secondary · From the date of randomization up until 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.

Group	Value	95% CI
Standard of Care	23
Oncology Nurse Navigation	28

Hospital Length of Stay Secondary · From the date of randomization until subject discontinued the intervention, assessed up to 34 months

Hospital length of stay was calculated for each subject as the total number of unplanned inpatient days while on intervention.

Group	Value	95% CI
Standard of Care	1	0 – 10
Oncology Nurse Navigation	4	0 – 92

Time From Hospice Referral to Death for Participants Referred to Hospice Secondary · From the date of hospice referral to death or last follow-up, assessed over 7 months.

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.

Group	Value	95% CI
Standard of Care	0.427	0.263 – 0.755
Oncology Nurse Navigation	0.526	0.296 – 1.084

Total Number of 30-day Readmissions Secondary · From the date of randomization until subject discontinued the intervention, assessed up to 34 months

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.

Group	Value	95% CI
Standard of Care	0	0 – 1
Oncology Nurse Navigation	0	0 – 1

Proportion of Participants Referred to Supportive Care Services Secondary · From the date of randomization until subject discontinued the intervention, assessed up to 34 months

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.

Group	Value	95% CI
Standard of Care	22
Oncology Nurse Navigation	50

Proportions of Missed Visits of All Scheduled Visits From 0% to 100%. Secondary · From the date of randomization until subject discontinued the intervention, assessed up to 34 months

This proportion was calculated for each participant as the percentage of missed visits of all scheduled within Atrium Health, regardless of visit type.

Group	Value	95% CI
Standard of Care	3.1	0.0 – 47.6
Oncology Nurse Navigation	2.2	0.0 – 60.0

Average Score of Subject Satisfaction as Assessed by an Adaptation of the EORTC PATSAT C33 Secondary · From the date of randomization up until 14 weeks

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

Group	Value	95% CI
Standard of Care	4.4	± 0.6
Oncology Nurse Navigation	4.6	± 0.5

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Patient Navigation in Cancer Treatment: A Systematic Review.
   Chen M, Wu VS, Falk D, Cheatham C, et al · · 2024 · cited 72× · PMID 38581470 · DOI 10.1007/s11912-024-01514-9