Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Lung Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Patients and care partners receive specialty primary care and participate in pre- and post- functional MRI scans to measure the effects of the specialty palliative care intervention.

Specialty palliative care, as opposed to primary palliative care.

Specialty Palliative Care

Amber Barnato, MD

This feasibility pilot study is designed to learn whether patients and their care partners (e.g., family members) are willing and able to complete two study visits at Dartmouth College while receiving cancer care at Dartmouth-Hitchcock Medical Center.

A feasibility pilot open label, single-arm observational case series of 10 patients with metastatic gastrointestinal and lung cancer patients and 10 care partners. Participants will complete two study visits, separated by approximately 8-16 weeks of usual oncologic care with early integrated specialty palliative care. The palliative care physician will also be a study participant.

Primary Objective: To develop and refine study procedures which can be used in future research in order to further understanding of the mechanisms of action of specialty palliative. Expected products: manual of operating procedures and web-based data collection forms.

Secondary Objectives: To test the feasibility of conducting a mechanism-focused clinical trial of primary palliative care vs. specialty palliative care for advanced cancer patients and their care partners. Expected products: preliminary data demonstrating the feasibility of study procedures sufficient to prove this study design is possible.

The Science of the Art of Palliative Care

The Science of the Art of Palliative Care Pilot

Establish acceptable operating procedures and data collection instruments which can be replicated for future projects.

Percent of participants approached and interested in participating

Percent of participants approached and enrolled

Percent of participants enrolled and willing to be randomized

Percent of participants randomized and completed procedures (specialty palliative care, fMRIs, surveys, bio response measurements).

Percent of participants not completing each study visit and specialty primary care visit

The SUDs Rating Scale, or Subjective Units of Distress Scale (SUDs) as it is officially known, is used to measure the intensity of distress or nervousness in people with social anxiety. The SUDs is a self-assessment tool rated on a scale from 0 to 100.

Percent of participants not completing each study procedures (specialty palliative care, fMRIs, surveys, bio response measurements).

Two closed-ended Likert scale items regarding study burdensomeness. (this investigator-created instrument is in development)

Measured by the Net Promoter Score - The Net Promoter Score is an index that measures the willingness of participants to recommend a services to others. It is used as a proxy for gauging overall satisfaction with a service. Net Promoter Score (scale from 0 to 10 with 3 groups: promoters for 9-10, passive for 7-8 and detractor for below 6).

Dartmouth College

Dartmouth-Hitchcock Medical Center

Director, The Dartmouth Institute

Blood and Lymph Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

- Participants will complete baseline self-report assessments at the time of informed consent

Participants assigned to specialty palliative care will be cared for by both oncology and palliative care clinicians during their hospital stays for AML.

Participants assigned primary palliative care will be cared for by oncology clinicians who have been trained in palliative care during the hospital stays for AML.

Primary Palliative Care

Areej El-Jawahri, MD

Porsha L Lark, MS, MPH

Dio Kavalieratos, MD

Martha Arellano, MD

Larry Cripe, MD

James Cleary, MD

Corey Tapper, MD

B. Douglas Smith, MD

Jennifer Temel, MD

Oreofe Odejide, MD, MPH

James Tulsky, MD

Mark Litzow, MD

Jacob Strand, MD

Laura Hanson, MD, MPH

William Wood, Jr., MD

Thomas LeBlanc, MD

Wil Santivasi, MD

Selina Luger, MD

Kathryn McGrath, MD

This research study is evaluating whether primary palliative care is an alternative strategy to specialty palliative care for improving quality of life, symptoms, mood, coping, and end of life outcomes in patients with acute myeloid leukemia (AML).

Patients with newly diagnosed AML confront a sudden and life-threatening diagnosis, requiring an immediate disruption of their life and an urgent hospitalization to begin therapy. During their hospitalization for chemotherapy, patients with AML often experience difficult physical symptoms that negatively impact their quality of life and physical function. Patients with AML also experience significant psychological distress as they combat the abrupt onset of illness, uncertainty regarding their prognosis, physical and social isolation during hospitalization, and complete loss of independence. The abrupt onset of these symptoms can be distressing to both the patient and their family and friends (also called "caregivers").

Research has shown that early involvement of a team of clinicians specializing in lessening (or "palliating") these physical and emotional symptoms and helping patients and their caregivers cope with AML improves their quality of life and experience with their illness. This team is called "specialty palliative care" and consists of physicians and advanced practice providers who work closely and collaboratively with the oncology team to care for patients and caregivers. Research has also shown that training oncology clinicians to incorporate palliative care skills into their practice, called "primary palliative care," is an alternative strategy to having specialty palliative care clinicians care for patients with leukemia.

The purpose of this study is to determine whether specialty palliative care or primary palliative care is the best way to improve the quality of life and experience of patients with AML and their caregivers. This study will randomly assign hospitals to deliver either specialty palliative care or primary palliative care for patients with AML. Participants in this study will receive either specialty or primary palliative care during their hospital stays based upon which strategy their hospital has been assigned to. Participants assigned to specialty palliative care will be care for by both oncology and palliative care clinicians during their hospital stays for AML. Participants assigned to primary palliative care will be cared for by oncology clinicians who have been trained in palliative care during their hospital stays for AML.

Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Compare patient prognostic understanding between those receiving primary palliative care and specialty palliative care based on the Prognostic Awareness Impact Scale (PAIS). The PAIS items that focus on the likelihood of cure will be used to compare prognostic understanding. Patients will report the likelihood of cure of their leukemia on a Likert's scale. Prognostic understanding will be dichotomized into likely cure versus. unlikely cure and compared between the two groups.

Compare patient coping between those receiving primary palliative care versus specialty palliative care using the Brief Cope. Higher scores on the domains of the Brief Cope indicate higher use of coping strategies.

Compare hospitalization in the last 30 days of life between those receiving primary palliative care versus specialty palliative care.

Compare intensive care unit admissions in the last 30 days of life between those receiving primary palliative care versus specialty palliative care.

Compare hospice utilization between those receiving primary palliative care versus specialty palliative care.

Compare hospice length of stay between those receiving primary palliative care versus specialty palliative care.

Compare patient symptom burden between those receiving primary palliative care versus specialty palliative care using the revised Edmonton Symptom Assessment Scale (ESAS-R).

Higher scores on ESAS-R (range 0 - 100) indicate greater symptom burden.

Compare patients' perception of patient-centeredness of care between those receiving primary palliative care versus specialty palliative care using the Patient Perception of Patient-Centeredness of Care (PPPC).

Higher scores indicate greater satisfaction with care.

Compare caregiver-reported end-of-life (EOL) communication between those receiving primary palliative care versus specialty palliative care measured by the Prognostic Awareness Impact Scale (PAIS). The PAIS includes an item that measures patient self-report of communication about their wishes if they were dying (yes vs. no).

Compare caregiver prognostic understanding between those receiving primary palliative care versus specialty palliative care based on the Prognositic Awareness Impact Scale (PAIS). PAIS items that focus on likelihood of cure will be used to compare prognostic understanding.

Compare caregiver coping between those receiving primary palliative care versus specialty palliative care using the Brief COPE. Higher scores on the domains of the Brief Cope indicate higher use of coping strategies.

Establish that primary palliative care is non-inferior to specialty palliative care in patient-reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia) over 12 weeks.

Higher scores on FACT-Leukemia (range 0-176) indicate a better QOL.

Assess whether primary palliative care is non-inferior to specialty palliative care with respect to patient-reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia).

Assess whether primary palliative care is non-inferior to specialty palliative care with depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).

Higher scores on HADS depression subscale (range 0-21) indicate greater depression symptoms.

Assess whether primary palliative care is non-inferior to specialty palliative care with anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).

Higher scores on HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.

Assess whether primary palliative care is non-inferior to specialty palliative care with respect to post-traumatic stress (PTSD) symptoms as measured by the Post-Traumatic Stress Checklist-Civilian version.

Higher scores on the Post-Traumatic Stress Checklist (range 17-85) indicate greater PTSD symptoms.

Assess whether primary palliative care is non-inferior to specialty palliative care with respect to patient reported end-of-life (EOL) communication measured by the Prognostic Awareness Impact Scale (PAIS).

The PAIS includes an item that measures patient self-report of communication about their wishes if they were dying (yes vs. no).

Assess whether primary palliative care is non-inferior to specialty palliative care with respect to chemotherapy administration in the last 30 days of life based on documentation from the Electronic Health Record.

Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver quality of life measured by the Caregiver Oncology QOL Questionnaire (CARGOQOL).

Higher scores on CARGOQOL (range 0-100) indicate better QOL.

Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver burden measured by the Caregiver Reaction Assessment (CRA).

Higher scores on the CRA (range 24-120) indicate greater caregiving burden.

Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS).

Higher scores on HADS depression subscale (range 0-21) indicate greater depression symptoms.

Assess whether primary palliative care is non-inferior to specialty palliative care with respect to caregiver anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS).

Higher scores on HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Science of the Art of Palliative Care	NCT05137782	Gastrointestina... Lung Cancer Advanced Cancer	Specialty Palli...	18 Years -	Dartmouth-Hitchcock Medical Center
Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia	NCT05237258	Relapsed Adult ... Primary Refract... High Risk Acute...	Specialty Palli... Primary Palliat...	18 Years - 120 Years	Massachusetts General Hospital
Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia	NCT05237258	Relapsed Adult ... Primary Refract... High Risk Acute...	Specialty Palli... Primary Palliat...	18 Years - 120 Years	Massachusetts General Hospital

Spots Global Cancer Trial Database for specialty palliative care