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 — BEHAVIORAL
    The 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: 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.
  • 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.

Primary Outcome Measure

participant reported symptom burden [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Good Samaritan University HospitalWest IslipNew York11795
Johnny Kao, MD
631-376-4047
LuAnn Rowland, MS, RN
(631) 376-4047

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