Inpatient Palliative Care for Patients Undergoing Hematopoietic Stem Cell Transplantation
NCT ID: NCT03641378
Last Updated: 2023-12-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
546 participants
INTERVENTIONAL
2018-09-30
2023-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Inpatient Palliative Care Intervention
* 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)
Palliative Care Intervention
team of clinicians that specialize in the lessening (palliation) of many distressing symptoms
Transplant Care Alone
* Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent.
* Standard Transplant Care
Standard Transplant Care
Standard care per hospital guidelines
Interventions
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Palliative Care Intervention
team of clinicians that specialize in the lessening (palliation) of many distressing symptoms
Standard Transplant Care
Standard care per hospital guidelines
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients undergoing outpatient HCT.
* Patients with psychiatric or cognitive conditions which the treating clinicians believes prohibits compliance with study procedures
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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El-Jawahri, Areej,M.D.
Principal Investigator
Principal Investigators
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Areej El-Jawahri, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Duke University
Durham, North Carolina, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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References
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El-Jawahri A, LeBlanc TW, Kavanaugh A, Webb J, Fausto J, Traeger L, Greer JA, Jackson V, Horick N, Rabideau DJ, Fenech A, Newcomb R, Ufere NN, Caruso E, Pepper J, DeFilipp Z, Chen YB, Lee SJ, Temel JS. Multisite Randomized Trial of Inpatient Palliative Care Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation. J Clin Oncol. 2025 Aug 20;43(24):2700-2711. doi: 10.1200/JCO-25-00378. Epub 2025 Jun 23.
Newcomb R, Amonoo HL, Kavanaugh AR, Wharton KC, Rowland M, Fausto J, Webb J, Jackson V, Greer JA, Temel JS, Lark P, Rabideau DJ, O'Brien K, LeBlanc TW, Lee SJ, El-Jawahri A. Factors associated with early quality-of-life response to palliative care during hematopoietic cell transplantation. Blood Adv. 2025 May 13;9(9):2033-2043. doi: 10.1182/bloodadvances.2024014574.
Yang D, Newcomb R, Kavanaugh AR, Khalil D, Greer JA, Chen YB, DeFilipp Z, Temel J, Lee SJ, LeBlanc TW, El-Jawahri A. Protocol for multi-site randomized trial of inpatient palliative care for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation. Contemp Clin Trials. 2024 Mar;138:107460. doi: 10.1016/j.cct.2024.107460. Epub 2024 Jan 26.
Newcomb R, Amonoo HL, Nelson AM, Choe J, Holmbeck K, Nabily A, Lee SJ, LeBlanc TW, El-Jawahri A. Coping in patients with hematologic malignancies undergoing hematopoietic cell transplantation. Blood Adv. 2024 Mar 26;8(6):1369-1378. doi: 10.1182/bloodadvances.2023011081.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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18-261
Identifier Type: -
Identifier Source: org_study_id