Clinical Nurse Specialist Led Early Palliative Survivorship Care for Patients With Advanced Cancer
Part of paid clinical trials in West Islip, New York.
- Sponsor
- Good Samaritan Hospital Medical Center, New York
- Study ID
- NCT05947695
- Status
- Recruiting
Conditions
- Metastasis
- Solid Tumor, Adult
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Palliative and Survivorship Care Model — BEHAVIORALThe standard of care comparator arm is usual clinical care using NCCN guidelines and evidence-based practice for palliative and survivorship care.
Study Details
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.
Key Dates
- Start date
- Mar 2, 2023
- Status verified
- Sep 2023
- Primary completion
- Mar 31, 2026
- Completion
- Mar 31, 2029
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: InterventionThe 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.
- Active Comparator: Standard of CareThe 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.
Primary Outcome Measure
participant reported symptom burden [ Time Frame: 24 months ]
Central Contacts
- Johnny Kao, MD631-376-4047
- LuAnn Rowland, MS RN631-376-4047
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Good Samaritan University Hospital | West Islip | New York | 11795 |
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