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CompletedNCT04602611ACCESSUpdated Jan 30, 2025Results posted

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

An interventional study of Oncology Nurse Navigation in Gastrointestinal Cancer, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-30.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
228
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gastrointestinal Cancer
03

In context

Gastrointestinal Neoplasms

795 studies on the registry are indexed under Gastrointestinal Neoplasms; 235 are open to participants now.

This study's enrollment of 228 is above the median of 60 across 580 interventional studies indexed under Gastrointestinal Neoplasms.

Browse Gastrointestinal Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.

Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.

Browse Wake Forest University Health Sciences studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
228 participants (actual)

Study arms

  • No intervention
    Standard of Care

    Standard of Care

  • Experimental
    Oncology Nurse Navigation

    Standard of Care + Oncology Nurse Navigation

    Other: Oncology Nurse Navigation

Interventions

  • OtherOncology Nurse Navigation

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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

    Time frame: From the date of randomization to death or 6 months

Secondary outcomes

  1. 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.

    Time frame: From the date of randomization up until 12 months

  2. Hospital Length of Stay

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

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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).

    Time frame: From the date of randomization up until 14 weeks

07

Results

Posted Jan 30, 2025

Participant flow

Participant flow — Overall Study
MilestoneStandard of CareOncology Nurse Navigation
Started115113
Completed115113
Not completed00

Outcome measures

PrimaryAnnualized 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.

Time frame:
From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Reported as:
Median · unplanned acute care visits in one year
Annualized Count of Acute Care Visits
unplanned acute care visits in one yearStandard of CareOncology Nurse Navigation
Annualized Count of Acute Care Visits3 (0 to 9.6)3.8 (1.3 to 7.7)
Statistical analysis
  • Standard of Care vs Oncology Nurse Navigation · Regression, Negative binomial · p = 0.80 (The a priori threshold for statistical significance was 0.025.) · Coefficient of negative binomial model: 0.0547 · 95% CI -0.3680 to 0.4773The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.
PrimaryProportion 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.

Time frame:
From the date of randomization to death or 6 months
Reported as:
Count of participants · Participants
Proportion of Participants Surviving at 6 Months
ParticipantsStandard of CareOncology Nurse Navigation
Proportion of Participants Surviving at 6 Months5258
Statistical analysis
  • Standard of Care vs Oncology Nurse Navigation · Fisher Exact · p = 0.88 (The a priori threshold for statistical significance was 0.025.)No adjustments were made in this analysis.
SecondaryProportion 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.

Time frame:
From the date of randomization up until 12 months
Reported as:
Count of participants · Participants
Proportion of Participants Surviving at 12 Months
ParticipantsStandard of CareOncology Nurse Navigation
Proportion of Participants Surviving at 12 Months2328
Statistical analysis
  • Standard of Care vs Oncology Nurse Navigation · Fisher Exact · p = 0.74 (This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.)No adjustments were made in this analysis.
SecondaryHospital Length of Stay

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

Time frame:
From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Reported as:
Median · Days
Hospital Length of Stay
DaysStandard of CareOncology Nurse Navigation
Hospital Length of Stay1 (0 to 10)4 (0 to 92)
Statistical analysis
  • Standard of Care vs Oncology Nurse Navigation · Regression, Negative binomial · p = 0.57 (This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.) · Coefficient of negative binomial model: 0.1574 · 95% CI -0.3905 to 0.7054The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.
SecondaryTime 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.

Time frame:
From the date of hospice referral to death or last follow-up, assessed over 7 months.
Reported as:
Median · months
Time From Hospice Referral to Death for Participants Referred to Hospice
monthsStandard of CareOncology Nurse Navigation
Time From Hospice Referral to Death for Participants Referred to Hospice0.427 (0.263 to 0.755)0.526 (0.296 to 1.084)
Statistical analysis
  • Standard of Care vs Oncology Nurse Navigation · Log Rank · p = 0.45 (This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.) · Hazard ratio (hr): 0.864 · 95% CI 0.570 to 1.309The estimated hazard ratio was associated with Oncology Nurse Navigation with reference to Standard of Care; the model was estimated without adjustments (the sole covariate was treatment).
SecondaryTotal 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.

Time frame:
From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Reported as:
Median · number of 30-day readmissions
Total Number of 30-day Readmissions
number of 30-day readmissionsStandard of CareOncology Nurse Navigation
Total Number of 30-day Readmissions0 (0 to 1)0 (0 to 1)
Statistical analysis
  • Standard of Care vs Oncology Nurse Navigation · Regression, Negative binomial · p = 0.21 (This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.) · Coefficient of negative binomial model: -0.4194 · 95% CI -1.0763 to 0.2374The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.
SecondaryProportion 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.

Time frame:
From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Reported as:
Count of participants · Participants
Proportion of Participants Referred to Supportive Care Services
ParticipantsStandard of CareOncology Nurse Navigation
Proportion of Participants Referred to Supportive Care Services2250
Statistical analysis
  • Standard of Care vs Oncology Nurse Navigation · Regression, Logistic · p = <0.01 (This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.) · Odds ratio (or): 3.28 · 95% CI 1.75 to 6.15The estimated odds ratio was associated with Oncology Nurse Navigation with reference to Standard of Care.
SecondaryProportions 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.

Time frame:
From the date of randomization until subject discontinued the intervention, assessed up to 34 months
Reported as:
Median · percentage of missed scheduled visits
Proportions of Missed Visits of All Scheduled Visits From 0% to 100%.
percentage of missed scheduled visitsStandard of CareOncology Nurse Navigation
Proportions of Missed Visits of All Scheduled Visits From 0% to 100%.3.1 (0.0 to 47.6)2.2 (0.0 to 60.0)
Statistical analysis
  • Standard of Care vs Oncology Nurse Navigation · Regression, Linear · p = 0.11 (This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.) · Slope: -2.6939 · 95% CI -5.9538 to 0.5659The estimated slope was associated with Oncology Nurse Navigation with reference to Standard of Care.
SecondaryAverage 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).

Time frame:
From the date of randomization up until 14 weeks
Reported as:
Mean · score on a scale (out of 5)
Average Score of Subject Satisfaction as Assessed by an Adaptation of the EORTC PATSAT C33
score on a scale (out of 5)Standard of CareOncology Nurse Navigation
Average Score of Subject Satisfaction as Assessed by an Adaptation of the EORTC PATSAT C334.4 ± 0.64.6 ± 0.5
Statistical analysis
  • Standard of Care vs Oncology Nurse Navigation · Regression, Linear · p = 0.09 (This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.) · Slope: 0.1197 · 95% CI -0.0315 to 0.4378The estimated slope was associated with Oncology Nurse Navigation with reference to Standard of Care.

Adverse events

Collected over From the date of randomization until subject discontinued study involvement, assessed up to 34 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Standard of Care72/115 (62.6%)——
Oncology Nurse Navigation77/113 (68.1%)——

Baseline characteristics

All randomized participants

Age, Categorical
Age, Categorical(Participants)Standard of CareOncology Nurse NavigationTotal
<=18 years011
Between 18 and 65 years5251103
>=65 years6361124
Age, Continuous
Age, Continuous(years)Standard of CareOncology Nurse NavigationTotal
Median66 (29 to 91)65 (18 to 88)66 (18 to 91)
Sex: Female, Male
Sex: Female, Male(Participants)Standard of CareOncology Nurse NavigationTotal
Female345286
Male8161142
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Standard of CareOncology Nurse NavigationTotal
Hispanic or Latino8210
Not Hispanic or Latino106111217
Unknown or Not Reported101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Standard of CareOncology Nurse NavigationTotal
American Indian or Alaska Native000
Asian224
Native Hawaiian or Other Pacific Islander000
Black or African American263056
White8580165
More than one race000
Unknown or Not Reported213
Region of Enrollment
Region of Enrollment(participants)Standard of CareOncology Nurse NavigationTotal
United States115113228
Diagnosis
Diagnosis(Participants)Standard of CareOncology Nurse NavigationTotal
Colorectal cancer (progression on or intolerant to fluorouracil, oxaliplatin and irinotecan therapy)6410
Locally advanced unresectable pancreatic cancer161632
Metastatic or unresectable biliary cancer161632
Metastatic or unresectable gastroesophageal cancer212041
Metastatic or unresectable hepatocellular carcinoma151631
Metastatic pancreatic414182
08

Study locations

1 site
  • Levine Cancer Institute
    Charlotte, North Carolina 28204, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 11, 2023
  • Informed consent form · May 8, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2020 to primary completion in Aug 2023, 33 months.

Results were first posted in Jan 2025, 1 year 5 months after primary completion.

Of 165 non-industry interventional studies with no phase under Gastrointestinal Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 71. This study's 33 months is close to that.

Counting every sponsor, half of 175 studies reached it within 32 months; a quarter within 16 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2020
First posted
Oct 26, 2020
StartActual
Nov 3, 2020
Primary completionActual
Aug 10, 2023
CompletionActual
Aug 10, 2023
Results first posted
Jan 30, 2025
Last update
Jan 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04602611
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Oct 26, 2020
Start date
Nov 3, 2020
Primary completion
Aug 10, 2023
Completion
Aug 10, 2023
Results posted
Jan 30, 2025
Last update
Jan 30, 2025

Study contacts

Mohamed Salem, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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