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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment Palliative and Survivorship Care Model, Early Palliative Care, Palliative and Survivorship Care Model, Multidisciplinary Palliative and Survivorship Care for advanced cancer?

Research shows that integrating palliative care with survivorship care can improve outcomes like pain management, self-efficacy (confidence in managing one's health), and depression in cancer survivors. A multidisciplinary approach, where a nurse specialist coordinates care, has been shown to improve quality of life and potentially extend survival for patients with metastatic cancer. ^{1 2 3 4 5}

Is nurse-led palliative care for advanced cancer safe for humans?

The available research on nurse-led palliative care models, including those integrated with survivorship care, does not specifically address safety concerns, but these models are generally focused on improving quality of life and managing symptoms, which suggests they are considered safe in practice. ^{1 2 4 5 6}

How is the Nurse-Led Palliative Care for Advanced Cancer treatment different from other treatments?

This treatment is unique because it integrates palliative care (supportive care for serious illness) with survivorship care, focusing on a multidisciplinary approach led by nurses to address the physical, psychological, and social needs of cancer patients. It aims to improve quality of life and care coordination, which is not typically emphasized in standard cancer treatments. ^{1 2 3 7 8}

Research Team

Johnny Kao, MD

Principal Investigator

Good Samaritan University Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Personalized Palliative and Survivorship Care for Patients With Metastatic Cancer Treated With Radiation Therapy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Bridging the gap: Palliative care integration into survivorship care. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effect and Efficiency of an Embedded Palliative Care Nurse Practitioner in an Oncology Clinic. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Meeting survivors' unmet needs: an integrated framework for survivor and palliative care. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Palliative care clinical nurse specialists leading enhanced supportive care in hepatopancreatobiliary cancer. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A risk analysis of cancer care in Norway: the top 16 patient safety hazards. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Nurse-led integration of palliative care for chronic obstructive pulmonary disease: An integrative literature review. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Primary Palliative Care for Patients with Advanced Hematologic Malignancies: A Pilot Trial of the SHARE Intervention. [2020]