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Completed

NCT Number: NCT04602611

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

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.

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Key information

Conditions

Gastrointestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Life expectancy is > 3 months

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Annualized Count of Acute Care Visits

    Time frame: 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.

  2. Proportion of Participants Surviving at 6 Months

    Time frame: 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.

Secondary outcomes

  1. Proportion of Participants Surviving at 12 Months

    Time frame: 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.

  2. Hospital Length of Stay

    Time frame: 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.

  3. Time From Hospice Referral to Death for Participants Referred to Hospice

    Time frame: 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.

  4. Total Number of 30-day Readmissions

    Time frame: 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.

  5. Proportion of Participants Referred to Supportive Care Services

    Time frame: 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.

  6. Proportions of Missed Visits of All Scheduled Visits From 0% to 100%.

    Time frame: 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.

  7. Average Score of Subject Satisfaction as Assessed by an Adaptation of the EORTC PATSAT C33

    Time frame: 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 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).

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Acronym: ACCESS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2020
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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