Clinical Nurse Specialist Led Early Palliative Survivorship Care for Patients With Advanced Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed 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.
SUBJECT SELECTION AND WITHDRAWAL Inclusion Criteria Inclusion criteria include adult patients with metastatic solid tumor malignancy who are in the NEAT groups 1 and 2 (very favorable and favorable prognostic curves respectively) and under the care of GSH oncology and radiation oncology clinicians.
Exclusion Criteria Patients with metastatic solid tumor malignancy who are < 21 years of age Adult patients with metastatic solid tumor malignancy who are in the NEAT groups 3 and 4 (standard risk and unfavorable prognostic curves respectively).
Ethical Considerations This study will be conducted with adherence to the International Conference Harmonized Guidelines for Good Clinical Practice (ICH-GCP) and the Code of Federal Regulations on human subjects' research (45 CFR 46). The study protocol is designed using GCP standards and federal regulations protecting human subjects in research. The protocol will undergo IRB review and determination prior to study commencement.
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 and Consent Process We 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. The rate of accrual can be estimated by reviewing prior publications of consecutive patients with metastatic disease referred to radiation oncology. From experience, approximately 70% of eligible patients will consent to a clinical trial.
As not to have undue influence with the oncology nurse specialist consenting patients, initial consent will be obtained by Dr. Johnny Kao, a research team member. The essential elements of consent will be included in the process with subjects being explained the purpose of the study, why they are being recruited to participate in the study, the total sample size of participants in the study, the procedures and interventions that will be conducted in the study, the duration of their participation in the study ( both in months and actual hours of research protocol within that timeframe), the potential and actual risks, discomfort, and benefits of participating in the study, the alternatives of participating in the study, the ability to withdraw from the study at any time without penalty, who to contact during the study with questions about the research protocol, who to contact during the study regarding their rights a s a research participant, how their data will be accessed, stored, and shared, if study findings will be shared with them, what happens in the event of a finding that needs intervention (e.g. high depression score requiring immediate referral and treatment). Potential study subjects will have adequate time to read consent (in 8th grade level), ask questions, and then discuss the study with significant others prior to signing consent. A signed copy of the consent will be provided to the participant. Ongoing consent will be assessed at each study timepoint.
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. Since our patients have various medical oncologists (Cancer Institute, New York Cancer, and Blood Specialists and others), there are varying outpatient Palliative Care and early Survivorship resources available in the control arm.
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. 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. As neither intervention is less than standard of care and are aligned with NCCN guidelines and evidence-based practice there are no additional risks or discomforts to the research participants. Additionally, the intervention in the study is designed based on the gold standard non-prescribing oncology nurse-specialist model, which is less resource intensive, and more sustainable, than requiring a prescriber to coordinate care. Therefore, each arm of the study requires the nurse to coordinate with prescribing practitioners and is not confounded with testing an advanced practice prescriber (physician-led) model. Lastly, the survey instruments measuring participant symptom burden, quality of life and distress are currently used during patient visits for assessment in usual clinical care.
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. Additionally, the signed consents and crosswalk aligning participants to their random ID will be kept in locked office in locked cabinet with access only by the PI. All records will be kept according to 45 CFR guidelines and then shredded.
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).
Early Withdrawal of Subjects from Trial Procedures 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 they also do not want their data used in the study, the subject's data will not be used in the analysis. However, the number of subjects who withdraw from the study, in either arm, will be maintained and compared as a proxy measure of feasibility of each approach.
When and How to Withdraw Subjects Subjects can withdraw from the study at any time by notifying the PI, Ms. 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.
TRIAL ALLOCATION Description 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). Using predetermined alphanumerical identification that complies with GCP principles allocation will occur with each consecutive participant that meets inclusion criteria and consents to participate.
STUDY PROCEDURES SCREENING FOR ELIGIBILITY We 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. The rate of accrual can be estimated by reviewing prior publications of consecutive patients with metastatic disease referred to radiation oncology. From experience, approximately 70% of eligible patients will consent to a clinical trial.
INTERVENTION AND STANDARD OF CARE ARMS
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.
STANDARD OF CARE (COMPARATOR ARM) 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. Since our patients have various medical oncologists (Cancer Institute, New York Cancer, and Blood Specialists and others), there are varying outpatient Palliative Care and early Survivorship resources available in the control arm.
SCHEDULE OF MEASUREMENTS 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.
SAFETY AND ADVERSE EVENTS This is a pragmatic randomized control trial with patient allocation to treatment arms currently used (1) standard of care with traditional management model according to NCCN guidelines and (2) oncology nurse clinical specialist-led multidisciplinary management approach with NCCN guidelines and additional components of assessment, navigation, referral from an oncology nurse clinical specialist. Adverse events (AEs), serious adverse events (SAEs), and unanticipated problems (UPs) are not expected due to the interventions being compared. However, Dr. Kao 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.
STUDY OUTCOME MEASUREMENTS AND ASCERTAINMENT Symptom burden at timepoints 0,1,2,3,4, & 5 is primary outcome measured using ESAS-r .
Secondary outcomes of QOL and distress using the NCCN revised distress thermometer and patient problem tool (see Table 2) [4, 11, 16, 17].
The tertiary outcome will be measured as overall survival rate across patient populations during study duration and up to 36 months after enrollment. Survival rate is a standard collected outcome in cancer registry data.
BASELINE AND INTERVENTION CLINICAL CHARACTERISTICS Baseline and clinical characteristics data will also be collected at each timepoint. These will include age, gender, race, ethnicity, type of malignancy, date of diagnosis, Eastern Cooperative Oncology Group (ECOG) performance status, albumin, Neutrophil to lymphocyte ratio, Primary tumor site, Number of active tumors, Liver metastases, Bone only metastases, Hospitalization within the prior 3 months, Prior systemic therapy regimens for distant metastases, Radiation dose intensity equivalent dose in 2 Gy fractions (EQD2.) STATISTICAL PLAN Primary endpoint The primary end point is the participants' overall change in reported symptom burden. The primary analysis will be a comparison of visit timepoint 3 (3 months post-d/c) for overall symptom burden in both treatment arms for participants belonging to the NEAT highly favorable and favorable groups via a one-tailed paired sample t test. The McNemar test will be used to compare the prevalence of the nine items. In comparison with the prevalence and scores of each category from timepoint 0 to timepoint 3, Fisher's exact test will be used to compare categorical variables, and the Mann-Whitney U-test will be used to compare continuous variables. A value of p < 0.05 will be considered statistically significant. Supplementary analysis of the primary end point will include comparison of average change from baseline to primary endpoint across groups via an ANCOVA estimate. Further, a linear mixed model with observations nested within participants across time (growth model) will provide insight into individual patient trajectories. Comparison of the proportion of patients reporting a clinically significant change across groups will be compared between groups using a chi- square test.
Power analysis A 1-point change in any of the nine items on the ESAS-r is considered clinically significant. To detect a 1-point improvement with 80% power and an alpha value of .05 with a one-tailed t-test requires 140 patients with a paired sample test under the assumption of a standard deviation of 3 points. In contrast, a 2-point change with the same dispersion estimate requires a minimum sample size of 38 patients. As similar prior studies have demonstrated a 5-10-point total score change in symptom burden within this patient population, we expect to have sufficient power for the primary research aim comparing total symptom burden scores. Clinical significance of a 1-point change in any of the nine items will be addressed with clinical interventions outside of the research.
Secondary endpoints Secondary analysis will include constructing a linear mixed model involving a hierarchical design to ascertain the impact of potential confounding covariates on the primary outcome. Each of the secondary end points will be analyzed in a manner similar to that of the primary end point. Correlation coefficients will assess the degree of redundancy and amount of shared variance among the symptom burden and distress end points. As these are longitudinal data, and there are multiple measures, a missing data plan is included in this protocol (see below).
Missing data plan With longitudinal studies there is a high probability of missing data due to study attrition and missed visits. As this is an intent to treat approach to analysis, all participant data (except when participant withdraws consent to use their data) will be included in the analysis. After determining the missingness of the data, a sensitivity analysis will estimate the effect of these data on the primary outcome estimate. Multiple imputations will not be done. Covariance structures used in the linear mixed model estimates, Toeplitz structure, will account for missing datapoints and differences in the timing between subjects' data collection timepoints.
DATA HANDLING AND RECORD KEEPING 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. Additionally, the signed consents and crosswalk aligning participants to their random ID will be kept in locked office in locked cabinet with access only by the PI. All records will be retained according to 45 CFR guidelines and then shredded. Research source documents and case reports will be kept separate from clinical records using the process described above.
SUBJECT STIPENDS OR PAYMENTS There will be no monetary stipends or payments to subjects.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention The oncology nurse-specialist-led multidisciplinary early intervention arm 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. |
Behavioral: Palliative and Survivorship Care Model
oncology clinical nurse specialist-led early intervention multidisciplinary palliative and survivorship model, as compared to the effect of standard of care approach to palliative care
|
| Active Comparator: Standard of Care The standard of care comparator arm is usual clinical care using NCCN guidelines and evidence-based practice for palliative and survivorship care for patients treated with distant metastases. |
Behavioral: Palliative and Survivorship Care Model
oncology clinical nurse specialist-led early intervention multidisciplinary palliative and survivorship model, as compared to the effect of standard of care approach to palliative care
|
Outcome Measures
Primary Outcome Measures
- participant reported symptom burden [24 months]
The Edmonton Symptom Assessment System- Revised (ESAS-r) will be used to measure patient reported symptom burden
Secondary Outcome Measures
- participant reported quality of life [24 months]
Updated NCCN Distress Thermometer Problem List for Patients will be used to measure participant reported quality of life
- participant reported distress [24 months]
Updated NCCN Distress Thermometer will be used to measure participant reported distress
- participant overall survival [60 months]
Measured as survival at 60 months
Eligibility Criteria
Criteria
Inclusion Criteria:
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adult patients (21 yrs and over)
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metastatic solid tumor malignancy with very favorable and favorable prognostic curves
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under the care of GSUH oncology and radiation oncology clinicians
Exclusion Criteria:
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patients with metastatic solid tumor malignancy who are < 21 yrs of age
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adult patients with metastatic solid tumor malignancy who are in standard risk and unfavorable prognostic curves
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patients not under the care of GSUH oncology and radiation oncology clinicians
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Good Samaritan University Hospital | West Islip | New York | United States | 11795 |
Sponsors and Collaborators
- Good Samaritan Hospital Medical Center, New York
Investigators
- Study Chair: Johnny Kao, MD, Good Samaritan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB# 22-009