Nurse-Led Palliative Care for Advanced Cancer

Overseen By LuAnn Rowland, MS RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Good Samaritan Hospital Medical Center, New York

Disqualifiers: Under 21, Standard risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 24 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to improve the well-being of patients with advanced cancer through a nurse-led care team. The aim is to determine if this approach, known as the Palliative and Survivorship Care Model, enhances patients' physical and emotional well-being compared to standard care. Participants will be divided into two groups: one receiving the new nurse-led care and the other receiving standard care. This study is suitable for adults with advanced solid tumors who have been consulting specific cancer specialists and maintain a positive outlook on their diagnosis. As an unphased trial, it offers patients the chance to contribute to innovative care strategies that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this palliative care model is safe?

Research has shown that early palliative care, which provides supportive care for serious illnesses, is generally safe and well-tolerated for adults with advanced cancer. Studies have found that this care can enhance quality of life by addressing physical, emotional, and social needs. No specific reports of negative effects from this approach exist. Instead, it focuses on relieving symptoms like pain and anxiety and improving overall well-being. Thus, joining a trial for palliative and survivorship care should be safe, with an emphasis on helping patients feel better during treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nurse-Led Palliative Care for Advanced Cancer because it introduces a unique approach centered around an oncology nurse-specialist who leads a multidisciplinary team. Unlike the standard care options, which follow NCCN guidelines for managing symptoms, this model adds an extra layer of coordinated care and patient education. This means patients receive personalized attention and faster referrals to necessary treatments, potentially improving their quality of life and making the care experience more seamless.

What evidence suggests that this palliative and survivorship care model is effective for advanced cancer?

Research has shown that starting palliative care early for people with advanced cancer can help manage symptoms like pain and anxiety and improve overall wellbeing. Studies have found that this approach boosts both physical and mental health, enhancing patients' comfort. In this trial, participants in the nurse-led intervention arm will receive early palliative care, focusing on organizing services, educating patients, and connecting them with resources. This supports findings that early palliative care is linked to less intense treatment at the end of life and possibly longer survival. Overall, early palliative care helps manage symptoms and enhances the quality of life for patients with advanced cancers. ^{1 6 7 8 9}

Who Is on the Research Team?

Johnny Kao, MD

Principal Investigator

Good Samaritan University Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 21 with metastatic solid tumors and a favorable prognosis, under the care of GSUH oncology. It's not for those younger than 21 or patients with standard to unfavorable prognostic curves who aren't treated by GSUH oncologists.

Inclusion Criteria

I am over 21 with a metastatic solid tumor and under care at GSUH.

Exclusion Criteria

I have a widespread cancer with a high-risk outlook.

I am under 21 years old with a metastatic solid tumor.

Patients not under the care of GSUH oncology and radiation oncology clinicians

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Oncology nurse-specialist-led multidisciplinary early intervention with standard of care, additional coordination of services, patient education, and referral to treatment

24 months

Visits at 3, 9, 15, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Palliative and Survivorship Care Model

Trial Overview

The study tests an early palliative and survivorship care model led by clinical nurse specialists against standard care. It aims to improve symptom burden, quality of life, distress levels, and overall survival in advanced cancer patients.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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.

Group II: Standard of Care Active Control 1 Intervention

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.

Palliative and Survivorship Care Model is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Palliative and Survivorship Care Model for:

• Advanced cancer
• Metastatic solid tumor malignancy

Approved in European Union as Early Palliative Care for:

• Advanced cancer
• Incurable cancer

Approved in Canada as Palliative and Survivorship Care Model for:

• Advanced cancer
• Metastatic solid tumor malignancy

Who Is Running the Clinical Trial?

Good Samaritan Hospital Medical Center, New York

Lead Sponsor

Trials

7

Recruited

6,900+

Published Research Related to This Trial

Patients with hepatopancreatobiliary cancer who received nurse-led enhanced supportive care (ESC) experienced less severe symptoms and improved mood over time, indicating better overall quality of life.

The ESC model also resulted in patients receiving 31% less chemotherapy towards the end of life while maintaining comparable survival rates, suggesting a more patient-centered approach to cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care clinical nurse specialists leading enhanced supportive care in hepatopancreatobiliary cancer. Benson, S., Wong, H., Olsson-Brown, A., et al.[2023]

Embedding a palliative care nurse practitioner in oncology clinics significantly improved advance care planning and increased hospice referrals for patients with advanced cancer, with referrals rising from 23% to 53% compared to control oncologists.

The study involved approximately 10,000 patients, with 2,829 having advanced cancer, and demonstrated that the model not only enhanced patient care but also revealed that about half of the NP's tasks could be performed by other staff, indicating potential for efficiency in care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and Efficiency of an Embedded Palliative Care Nurse Practitioner in an Oncology Clinic. Walling, AM., D'Ambruoso, SF., Malin, JL., et al.[2018]

A prognostic model developed at Good Samaritan University Hospital categorizes patients with metastatic solid tumors into four groups based on survival, which can help tailor palliative and survivorship care more effectively.

The proposed multidisciplinary care model emphasizes the role of a Clinical Nurse Specialist in radiation oncology to coordinate interventions that address the physical and emotional needs of cancer survivors, aiming to enhance their quality of life and potentially improve survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Palliative and Survivorship Care for Patients With Metastatic Cancer Treated With Radiation Therapy. Siddiqui, S., Rowland, L., Copel, E., et al.[2023]

Integrating palliative care (PC) into survivorship care for cancer survivors shows promise, with 20 articles reviewed highlighting various multidisciplinary models that address physical, psychological, and social needs.

Some studies indicated that this integrated approach can lead to improvements in pain management, self-efficacy, depression, and overall function, but the overall evidence is limited, suggesting a need for more rigorous research to evaluate outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the gap: Palliative care integration into survivorship care. Morgan, B., Kapadia, V., Crawford, L., et al.[2023]

Nurse-led models integrating palliative care for patients with chronic obstructive pulmonary disease (COPD) are rare, but when implemented, they have shown positive outcomes, particularly in advance care planning and improving end-of-life discussions.

The review highlighted a significant gap in qualitative research on nurse-led palliative care models for COPD, indicating a need for further exploration to address the comprehensive needs of patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-led integration of palliative care for chronic obstructive pulmonary disease: An integrative literature review. Ora, L., Mannix, J., Morgan, L., et al.[2020]

A nurse-led primary palliative care intervention was developed and tested for patients with advanced hematologic malignancies, showing that 69% of patients and 100% of caregivers felt it helped them understand the illness and cope better.

While the intervention was well-received by caregivers and oncologists, the study faced challenges with enrollment, indicating that future efforts should focus on enhancing patient and clinician involvement to improve feasibility and acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Palliative Care for Patients with Advanced Hematologic Malignancies: A Pilot Trial of the SHARE Intervention. Resick, JM., Sefcik, C., Arnold, RM., et al.[2020]

A national risk analysis in Norway identified 16 critical hazards in cancer care, focusing on diagnosis, treatment interactions, and complications, which were selected by a consensus of health professionals.

Follow-up studies revealed that hospital trusts struggled to implement effective solutions to mitigate these hazards, highlighting a need for increased capacity to address patient safety in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A risk analysis of cancer care in Norway: the top 16 patient safety hazards. Hannisdal, E., Arianson, H., Braut, GS., et al.[2019]

An integrated framework for survivorship and palliative care in cancer patients can enhance the coordination of care and prioritize patient needs throughout their treatment journey.

This proposed model can be utilized in nursing practice to develop survivorship care plans, promoting a multidisciplinary approach to managing the complex needs of cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting survivors' unmet needs: an integrated framework for survivor and palliative care. Griffith, KA., McGuire, DB., Russo, M.[2013]

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Finally, current models of palliative, supportive, and survivorship care are not uniformly defined and organized within health care systems.

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Treatment, Palliative Care, and Survivorship Research

Interventions focused on symptoms management, treatment adherence, patient-reported outcomes, co-morbidities, psychological, spiritual, and physical well-being, ...