Clinical Nurse Specialist Led Early Palliative Survivorship Care for Patients With Advanced Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorGood Samaritan Hospital Medical Center, New York

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Palliative and Survivorship Care Model

    Behavioral

    The standard of care comparator arm is usual clinical care using NCCN guidelines and evidence-based practice for palliative and survivorship care.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

participant reported symptom burden

The Edmonton Symptom Assessment System- Revised (ESAS-r) will be used to measure patient reported symptom burden

Time frame
24 months

Secondary outcomes

1

participant reported quality of life

Updated NCCN Distress Thermometer Problem List for Patients will be used to measure participant reported quality of life

Time frame
24 months
2

participant reported distress

Updated NCCN Distress Thermometer will be used to measure participant reported distress

Time frame
24 months
3

participant overall survival

Measured as survival at 60 months

Time frame
60 months

Other outcomes

Sponsors and contacts

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