Gastrointestinal Cancer
Conditions
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.
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.
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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Count of Acute Care Visits | 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. |
| Proportion of Participants Surviving at 6 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Total Number of 30-day Readmissions | 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. |
| Proportion of Participants Surviving at 12 Months | 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. |
| Proportions of Missed Visits of All Scheduled Visits From 0% to 100%. | 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. |
| Average Score of Subject Satisfaction as Assessed by an Adaptation of the EORTC PATSAT C33 | 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). |
| Proportion of Participants Referred to Supportive Care Services | 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. |
| Hospital Length of Stay | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Standard of Care | 115 |
| Oncology Nurse Navigation Standard of Care + Oncology Nurse Navigation
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. | 113 |
| Total | 228 |
Baseline characteristics
| Characteristic | Standard of Care | Oncology Nurse Navigation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 63 Participants | 61 Participants | 124 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 51 Participants | 103 Participants |
| Age, Continuous | 66 years | 65 years | 66 years |
| Diagnosis Colorectal cancer (progression on or intolerant to fluorouracil, oxaliplatin and irinotecan therapy) | 6 Participants | 4 Participants | 10 Participants |
| Diagnosis Locally advanced unresectable pancreatic cancer | 16 Participants | 16 Participants | 32 Participants |
| Diagnosis Metastatic or unresectable biliary cancer | 16 Participants | 16 Participants | 32 Participants |
| Diagnosis Metastatic or unresectable gastroesophageal cancer | 21 Participants | 20 Participants | 41 Participants |
| Diagnosis Metastatic or unresectable hepatocellular carcinoma | 15 Participants | 16 Participants | 31 Participants |
| Diagnosis Metastatic pancreatic | 41 Participants | 41 Participants | 82 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 2 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants | 111 Participants | 217 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 30 Participants | 56 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 85 Participants | 80 Participants | 165 Participants |
| Region of Enrollment United States | 115 participants | 113 participants | 228 participants |
| Sex: Female, Male Female | 34 Participants | 52 Participants | 86 Participants |
| Sex: Female, Male Male | 81 Participants | 61 Participants | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 72 / 115 | 77 / 113 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date and (b) died within six months of enrollment or otherwise were on study for at least 6 months.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Annualized Count of Acute Care Visits | 3 unplanned acute care visits in one year |
| Oncology Nurse Navigation | Annualized Count of Acute Care Visits | 3.8 unplanned acute care visits in one year |
Comparison: The study was designed with co-primary objectives evaluating acute care utilization (ACU) and 6-month OS rate. Power/sample size were calculated based on the OS objective. The overall type I error rate was alpha=0.05; the co-primary objectives were powered at the 2-sided alpha=0.025 significance level. Three hundred evaluable subjects would have provided \>=93% power to detect a 20% reduction in ACU (assuming there were 6 ACUs per year in SOC arm). The study did not achieve targeted enrollment.p-value: 0.895% CI: [-0.368, 0.4773]Regression, Negative binomial
Primary
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
Population: Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date and (b) died within six months of enrollment or otherwise were on study for at least 6 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Proportion of Participants Surviving at 6 Months | 52 Participants |
| Oncology Nurse Navigation | Proportion of Participants Surviving at 6 Months | 58 Participants |
Comparison: The study was designed with co-primary objectives evaluating acute care utilization (ACU) and 6-month OS rate. Power/sample size were calculated based on the OS objective. The overall type I error rate was alpha=0.05; the co-primary objectives were powered at the 2-sided alpha=0.025 significance level. Three hundred evaluable subjects would have provided \>=93% power to detect a 20% reduction in ACU (assuming there were 6 ACUs per year in SOC arm). The study did not achieve targeted enrollment.p-value: 0.88Fisher Exact
Secondary
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
Population: Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date, (b) died within six months of enrollment or otherwise were on study for at least 6 months, and (c) completed the subject satisfaction survey 10-14 weeks after randomization (86/228 participants).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Average Score of Subject Satisfaction as Assessed by an Adaptation of the EORTC PATSAT C33 | 4.4 score on a scale (out of 5) | Standard Deviation 0.6 |
| Oncology Nurse Navigation | Average Score of Subject Satisfaction as Assessed by an Adaptation of the EORTC PATSAT C33 | 4.6 score on a scale (out of 5) | Standard Deviation 0.5 |
p-value: 0.0995% CI: [-0.0315, 0.4378]Regression, Linear
Secondary
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
Population: Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date and (b) died within six months of enrollment or otherwise were on study for at least 6 months.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Hospital Length of Stay | 1 Days |
| Oncology Nurse Navigation | Hospital Length of Stay | 4 Days |
p-value: 0.5795% CI: [-0.3905, 0.7054]Regression, Negative binomial
Secondary
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
Population: Enrolled participants who both (a) receive at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date and (b) die within six months of enrollment or otherwise are on study for at least 6 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Proportion of Participants Referred to Supportive Care Services | 22 Participants |
| Oncology Nurse Navigation | Proportion of Participants Referred to Supportive Care Services | 50 Participants |
p-value: <0.0195% CI: [1.75, 6.15]Regression, Logistic
Secondary
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
Population: Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date and (b) died within six months of enrollment or otherwise were on study for at least 6 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Proportion of Participants Surviving at 12 Months | 23 Participants |
| Oncology Nurse Navigation | Proportion of Participants Surviving at 12 Months | 28 Participants |
p-value: 0.74Fisher Exact
Secondary
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
Population: Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date and (b) died within six months of enrollment or otherwise were on study for at least 6 months.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Proportions of Missed Visits of All Scheduled Visits From 0% to 100%. | 3.1 percentage of missed scheduled visits |
| Oncology Nurse Navigation | Proportions of Missed Visits of All Scheduled Visits From 0% to 100%. | 2.2 percentage of missed scheduled visits |
p-value: 0.1195% CI: [-5.9538, 0.5659]Regression, Linear
Secondary
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.
Population: Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date, (b) died within six months of enrollment or otherwise were on study for at least 6 months, and (c) were referred to hospice (82/228 participants).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Time From Hospice Referral to Death for Participants Referred to Hospice | 0.427 months |
| Oncology Nurse Navigation | Time From Hospice Referral to Death for Participants Referred to Hospice | 0.526 months |
p-value: 0.4595% CI: [0.57, 1.309]Log Rank
Secondary
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
Population: Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date, (b) died within six months of enrollment or otherwise were on study for at least 6 months, and (c) had at least one in-patient admission (115/228 participants).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Total Number of 30-day Readmissions | 0 number of 30-day readmissions |
| Oncology Nurse Navigation | Total Number of 30-day Readmissions | 0 number of 30-day readmissions |
p-value: 0.2195% CI: [-1.0763, 0.2374]Regression, Negative binomial