A Randomized Controlled Trial of Clinical Nurse Specialist Led Early Palliative Survivorship Care for Patients With Advanced Cancer
Good Samaritan Hospital Medical Center, New York
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…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * adult patients (21 yrs and over) * metastatic solid tumor malignancy with very favorable and favorable prognostic curves * under the care of GSUH oncology and radiation oncology clinicians Exclusion Criteria: * patients with metastatic solid tumor malignancy who are \< 21 yrs of age * adult patients with metastatic solid tumor malignancy who are in standard risk and unfavorable prognostic curves * patients not under the care of GSUH oncology and radiation oncology clinicians
Interventions
- BehavioralPalliative and Survivorship Care Model
The standard of care comparator arm is usual clinical care using NCCN guidelines and evidence-based practice for palliative and survivorship care.
Location
- Good Samaritan University HospitalWest Islip, New York