Inpatient Palliative Care for Patients Undergoing Hematopoietic Stem Cell Transplantation

Massachusetts General Hospital546 enrolled

Overview

This research study is evaluating the impact of early involvement of a palliative care team working with the transplant oncology team will have on the quality of life, symptoms, and mood of patients undergoing stem cell transplantation.

The Participant has a type of blood cancer and will be undergoing stem cell transplantation. Frequently people undergoing stem cell transplantation experience physical and emotional symptoms during the course of their hospitalization for stem cell transplantation. These can be very distressing to both patient and the family members. The study doctors want to know if the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these distressing symptoms may improve the participant overall care. This team of clinicians is called the palliative care team and they focus on ways to improve the participant pain and other symptom management (nausea, fatigue, shortness of breath, anxiety, etc.) and to assist the participant and the participant's family in coping with the emotional and social issues associated with your diagnosis. The team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing serious illness. The main purpose of this study is to compare two types of care - standard transplant oncology care and standard transplant oncology care with early involvement of palliative care clinicians to see which is better for improving the experience of patients and families with blood cancers undergoing stem cell transplantation. The purpose of this research study is to find out whether introducing patients and families undergoing stem cell transplantation to the palliative care team that specializes in symptom management can improve the physical and psychological symptoms that patients and families experience during hospitalization for stem cell transplantation. The study will use a series of questionnaires to measure the participant and the participant 's caregivers' quality of life, physical symptoms, and mood. Study questionnaires will be completed in the hospital or clinic with assistance provided as need.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

546

Conditions

Stem Cell Transplant

Interventions

Palliative Care InterventionOTHER

team of clinicians that specialize in the lessening (palliation) of many distressing symptoms

Standard Transplant CareOTHER

Standard care per hospital guidelines

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patient Inclusion Criteria * adult patients (≥ 18 years) with hematologic malignancy admitted for autologous or allogeneic HCT. * ability to read and respond to questions in English or Spanish or to complete questionnaires with assistance from an interpreter. Caregiver Eligibility Criteria: * adult (≥ 18 years) relative or a friend of a patient who agrees to participate in the study whom the patient identified as living with them or having in-person contact with him or her at least twice per week. * ability to read and respond to questions in English or Spanish or to complete questionnaires with the assistance of an interpreter. Exclusion Criteria: Patient Exclusion Criteria * Patients undergoing HCT for benign hematologic conditions * Patients undergoing outpatient HCT. * Patients with psychiatric or cognitive conditions which the treating clinicians believes prohibits compliance with study procedures

Locations (3)

Massachusetts General Hospital

Boston, Massachusetts, United States

Duke University

Durham, North Carolina, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

Patient-reported Quality of Life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)

Compare patient QOL using the Functional Assessment of Cancer Therapy- Bone Marrow Transplant (FACT-BMT) scores at week 2 between the study groups Score range 0-164 with higher score indicating better quality of life

Time frame: 2 weeks

Secondary Outcomes

Patients' Quality of Life (QOL) Longitudinally: FACT-BMT

Compare patients' QOL using Functional Assessment of Cancer Therapy- Bone Marrow Transplant (FACT-BMT) longitudinally between the study groups Score range 0-164, with higher score indicating better quality of life

Time frame: up to 6 months

Patients' Symptom Burden

Compare patients' symptoms using the revised Edmonton Symptom Assessment Scale (ESAS) scores between the study groups score range 0-100 with higher score indicating worse symptom burden

Time frame: up to 6 months

Patients' Fatigue

Compare patients' fatigue using Functional Assessment of Cancer Therapy- Fatigue (FACT-fatigue) scores between the study groups score range from 0-52 with higher scores indicating lower fatigue symptoms

Time frame: up to 6 months

Patients' Psychological Distress

Compare patients' depression and anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS) between the study groups The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)

Time frame: up to 6 months

Patients' Depression

Compare patients' depression using Patient-Health Questionnaire - 9 (PHQ-9) between the study groups the PHQ-9 score ranges from 0-27, with higher score indicative more depressive symptoms

Data from ClinicalTrials.gov

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