Actively Recruiting
A Randomized Controlled Trial of Clinical Nurse Specialist Led Early Palliative Survivorship Care for Patients With Advanced Cancer
Led by Good Samaritan Hospital Medical Center, New York · Updated on 2023-09-13
100
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an early intervention led by an oncology clinical nurse specialist that uses a multidisciplinary approach to palliative and survivorship care for adults with metastatic solid tumor malignancies. This randomized control trial aims to compare this nurse-led care model to the standard palliative care approach, focusing on patient-reported symptom burden, overall quality of life, distress, and overall survival. The study targets patients in favorable and very favorable risk groups to evaluate the impact on symptoms like pain, tiredness, nausea, depression, anxiety, and wellbeing. Participants will be assigned randomly to either the nurse-specialist-led intervention or the standard care group. The intervention group receives usual care plus additional coordinated services, patient education, referrals, and ongoing support from the oncology nurse-specialist, including in-person visits and scheduled telephone follow-ups. The standard care group follows usual clinical guidelines with physician and nursing visits scheduled typically at 3, 9, 15, and 24 months. Both groups will complete surveys at multiple timepoints to assess symptoms and quality of life throughout the study period. During the 24-month study, participants will complete validated questionnaires to report symptoms, distress, and quality of life, supported by nursing staff. Data collection occurs at six timepoints using brief surveys that take about 5-6 minutes each. The research team will monitor safety regularly, tracking any adverse events. Survival data will be followed for up to 60 months. Participants can withdraw at any time without affecting their medical care. Total survey time is about 50 minutes for standard care and 85 minutes for the intervention group over 24 months.
CONDITIONS
Brief Title
Clinical Nurse Specialist Led Early Palliative Survivorship Care for Patients With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 21 years and older
- Diagnosis of metastatic solid tumor malignancy with very favorable or favorable prognostic risk groups
- Under the care of Good Samaritan Hospital Medical Center oncology and radiation oncology clinicians
You will not qualify if you...
- Patients younger than 21 years of age
- Patients with metastatic solid tumor malignancy who fall into standard risk or unfavorable prognostic groups
- Patients not under the care of Good Samaritan Hospital Medical Center oncology and radiation oncology clinicians
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants are enrolled and randomized from inpatient or outpatient settings to either the nurse-specialist-led intervention or standard care group.
1 enrollment visit (in-person)
Duration - Up to 24 months
Participants receive either standard clinical care or nurse-specialist-led multidisciplinary care involving additional coordination, education, and referrals to support palliative and survivorship needs.
In-person visits at approximately 3, 9, 15, and 24 months; additional phone calls and visits as needed
Duration - Up to 60 months
Participants are monitored for overall survival and ongoing symptom burden, quality of life, and distress up to 60 months after enrollment.
Periodic assessments aligned with routine clinical visits
Trial Site Locations
Total: 1 location
1
Good Samaritan University Hospital
West Islip, New York, United States, 11795
Actively Recruiting
Research Team
J
Johnny Kao, MD
L
LuAnn Rowland, MS RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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