Inpatient Palliative Care for Patients Undergoing Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi-Site Randomized Trial of Inpatient Palliative Care for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation

Conditions
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Stem Cell Transplant

Intervention / Treatment
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* Other: Palliative Care Intervention
* Other: Standard Transplant Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inpatient Palliative Care Intervention<br>Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent Palliative Care Intervention Therapeutic Relationship --Develop a strong therapeutic relationship with patients and caregivers Assessment and Treatment of Patient Symptoms --Clarify the symptoms the patient will likely experience and offer reassurance about the methods for reporting and treating symptoms Managing Patients and Caregivers Expectations --Address early on patients and caregivers' concerns about the trajectory of illness during HCT and treatment side effects Coping with Illness and HCT --Introduce strategies to help improve adjustment (e.g., behavioral, cognitive, and spiritual approaches; accepting illness while maintaining hope; social support) | Other: Palliative Care Intervention<br>* team of clinicians that specialize in the lessening (palliation) of many distressing symptoms<br>|
| Experimental: Transplant Care Alone<br>Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent. Standard Transplant Care | Other: Standard Transplant Care<br>* Standard care per hospital guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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) | 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 | up to 6 months | 
| Patients' Post-traumatic Stress Symptoms (PTSD) | Compare patients' post-traumatic stress symptoms using the PTSD Checklist- Civilian version (PCL-C) between the study groups PCL-C score ranges from 17-85 with higher scores indicating worse PTSD symptoms | up to 6 months | 
| Caregiver QOL: CARGOQOL | Compare caregivers' QOL using caregiver oncology QOL questionnaire (CARGOQOL) scores between the study groups the caregiver oncology QOL questionnaire ranges from 0-116 with higher scores indicating better caregiver QOL. | up to 6 months | 
| Caregiver Psychological Distress | Compare caregivers' psychological distress using 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) | up to 6 months | 
| Caregiver Depression | Compare caregivers' depression symptoms using the Patient Health Questionnaire - 9 (PHQ-9) between the study groups the PHQ-9 score ranges from 0-27 with higher scores indicating worse depression symptoms. | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Care