Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05947695 |
| Other study ID # |
IRB# 22-009 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2, 2023 |
| Est. completion date |
March 2029 |
Study information
| Verified date |
September 2023 |
| Source |
Good Samaritan Hospital Medical Center, New York |
| Contact |
Johnny Kao, MD |
| Phone |
631-376-4047 |
| Email |
Johnny.Kao[@]chsli.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the randomized control trial is to estimate the effect of an oncology clinical
nurse specialist-led early intervention multidisciplinary approach to palliative and
survivorship care within two previously identified and validated patient groups having
metastatic solid tumor malignancy on patient-reported symptom burden, patient-reported
overall quality of life (QOL), distress, and overall survival. The primary hypothesis is that
the effect of an oncology clinical nurse specialist- led early intervention multidisciplinary
palliative and survivorship care model will be significantly higher, as compared to the
standard of care approach to palliative and survivorship care, on the primary endpoint of
patient-reported symptom burden for patients with metastatic solid tumor malignancy within
favorable and very favorable risk groups. Symptom burden includes pain, tiredness,
drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, and
wellbeing.
Description:
OVERVIEW OF DESIGN SUMMARY This is an unblinded randomized control trial estimating the
effect of an oncology clinical nurse specialist- led early intervention multidisciplinary
approach to palliative and survivorship care within two previously identified and validated
patient groups having metastatic solid tumor malignancy on patient-reported symptom burden,
patient-reported quality of life (QOL), distress, and overall survival.
Randomization Method and Blinding Subjects will be randomized using a stratified approach
consisting of two strata- subjects enrolled from inpatient recruitment and subjects enrolled
from outpatient recruitment. Within each stratum a block randomization design (with varying
block sizes of 4, 6, and 8). Block sizes will be masked to research team as patient
allocation to treatment arm is not blinded. Stratified randomization with varying block sizes
will reduce potential of nonequivalence in treatment arms secondary to the heterogeneity of
the population being sampled.
Subject Recruitment Plans The researchers will recruit n= 100 patients from the favorable and
very favorable NEAT Groups. Recruitment will occur upon admission for inpatients when
diagnosed at stage 4 with metastatic disease (approximately 30% of total way of entry into
our facility's radiation oncology patient population) and outpatient (mainly- approx. 70% of
way of entry into our facility's radiation oncology patient population). All eligible adult
patients with metastatic disease seen in radiation oncology will be offered enrollment in
this trial.
Risks and Benefits The standard of care comparator arm is usual clinical care using NCCN
guidelines and evidence-based practice for palliative and survivorship care. The usual
practice (standard of care) for patients treated with distant metastases. Typically, there
are physician and nursing visits at 3 months, 9 months, 15 months, and 24 months although
this of course varies by diagnosis and whether patients require further treatment.
The risks associated with participation in the study involve:
The risk to confidentiality of data if there is a data breach when the data are being used
for research purposes. For mitigation of this risk a robust data protection plan that
includes de identification of the data with a randomly assigned code; double password
protected files for all research data; encryption and transfer of files via secure firewall
protected networks; storage of paper documents in locked file cabinet in locked office.
Survey fatigue is also a risk. The surveys chosen: Edmonton Symptom Assessment System-
Revised (ESAS-r)- (patient burden- on average less than 5 minutes to complete), Updated NCCN
Distress Thermometer and Problem List for Patients (patient burden- on average less than 5
minutes to complete), NCCN Survivorship Assessment is a 28-question assessment (patient
burden- on average less than 5 minutes to complete).
Subjects can withdraw from the study at any time without risk to relationship with clinicians
or alterations in medical care. There are no risks to early withdrawal. If subjects do
withdraw and determine to not want their data used in the study, the subject's data will not
be used in the analysis.
Subjects can withdraw from the study at any time by notifying the Principal Investigator in
person, via telephone, or in writing.
Data Collection and Follow-up for Withdrawn Subjects Data will be collected at timepoints 0,
1, 2, 3, 4, & 5. Data collection is using valid and reliable instruments for this population.
Data will be collected via paper and pencil with nurse or oncology nurse-specialist
supporting patient and family during survey completion. Each survey(n=2 for standard of care
group and n=3 for the clinical nurse-led group) takes 6 minutes on average to complete and
are used during assessment in usual clinical care.
Subjects who withdraw can determine if the data already collected can be used in the study.
An intention-to treat approach will be used in the analysis of the data.
Block sizes will be masked to research team as patient allocation to treatment arm is not
blinded. Subjects will be randomized using a stratified approach consisting of two strata-
subjects enrolled from inpatient recruitment and subjects enrolled from outpatient
recruitment. Within each stratum a block randomization design (with varying block sizes of 4,
6, and 8).
The oncology nurse-specialist led multidisciplinary early intervention arm also includes
standard of care with additional coordination of services, patient education, and referral to
treatment and other resources aligned with comprehensive best practice models for
multidisciplinary care teams. The patients will see the oncology nurse-specialist in person
in the visits specified . There is the assumption that there will be additional visits via
scheduled telephone calls in response to the patient in-person visit assessments and when
patients reach out directly to the oncology nurse-specialist. The oncology nurse-specialist
and radiation oncologist will work together to facilitate interventions based on the patient
response. For example, if the patient needs medications , the multidisciplinary team will
ensure the patient is prescribed the medications with emphasis placed on follow-up care. The
oncology nurse specialist will utilize resources and coordinate care for the individualized
needs identified by the patient. This will include (but not limited to) empathetic process
and coaching techniques to ensure adherence to prescribed therapeutics. Identified needs may
also result in coordinated care with practitioners/specialists-this all depends on the
identified needs. The main goal is to provide individualized personal care to the patient,
ensure adherence to prescribed treatments, employ the therapeutic process to promote health
and overall well-being.
The standard of care comparator arm is usual clinical care using NCCN guidelines and
evidence-based practice for palliative and survivorship care. The usual practice (standard of
care) for patients treated with distant metastases. Typically, there are physician and
nursing visits at 3 months, 9 months, 15 months, and 24 months although this of course varies
by diagnosis and whether patients require further treatment.
Data will be collected at timepoints 0, 1, 2, 3, 4, and 5 . Data collection is using valid
and reliable instruments for this population . Data will be collected via paper and pencil
with nurse or oncology nurse-specialist supporting patient and family during survey
completion. The surveys (n=3) take < 5 minutes on average to complete for the first 2
instruments that both the standard of care and intervention arm will complete and are used
during assessment in usual clinical care. Additionally, the intervention arm will complete
the NCCN Survivorship Assessment (28-question assessment) at each visit timepoints 0-5. The
total subject burden is 50 minutes (on average) over the 24-month study for the standard of
care arm and 85 minutes (on average) for the intervention arm.
Adverse events (AEs), serious adverse events (SAEs), and unanticipated problems (UPs) are not
expected due to the interventions being compared. However, the treating clinician will
monitor patient safety on an ongoing basis. Any AEs, SAEs, or Ups will be reviewed by the
research and clinical team within 48 hours and a determination made as to required follow up
and reporting. All events will be kept in a research record log for monthly aggregation and
trending analysis by the research team. AEs and Ups will be classified by severity,
relationship, and expectedness. These data will be collected with each timepoint assessment
by the oncology CNS or co-investigator.
There will be no monetary stipends or payments to subjects.
