Stem Cell TransplantNCT03641378
Inpatient Palliative Care for Patients Undergoing Hematopoietic Stem Cell Transplantation
A study testing Palliative Care Intervention and Standard Transplant Care in people with Stem Cell Transplant, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stem Cell Transplant
- What is being tested?
- Palliative Care Intervention and Standard Transplant Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Sep 2018to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02215
Duke University
Durham, North Carolina, 27705
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Multi-Site Randomized Trial of Inpatient Palliative Care for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation
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.
Read the detailed description
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.
- Conditions
- Stem Cell Transplant
- Being tested
- Palliative Care Intervention, Standard Transplant Care
- Keywords
- Cancer Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative Care InterventionOther
team of clinicians that specialize in the lessening (palliation) of many distressing symptoms
Standard Transplant CareOther
Standard care per hospital guidelines
| Study group | Role | What they receive |
|---|---|---|
| Inpatient Palliative Care Intervention | Experimental | * 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) Receives: Other: Palliative Care Intervention |
| Transplant Care Alone | Experimental | * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent.
* Standard Transplant Care Receives: Other: Standard Transplant Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start30 Sep 2018
- Primary completion1 Jul 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
- Investigators
- Areej El-Jawahri, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641378
- Sponsor's protocol ID
- 18-261
- Other IDs
- R01CA222014
- Status last verified
- Dec 2023
- First submitted
- 14 Aug 2018
- Last updated
- 7 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40549982Newcomb 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.
PubMed 39908568Yang 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.
PubMed 38280483Newcomb 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.
PubMed 38181820
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Site Randomized Trial of Inpatient Palliative Care for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03641378
- Acronym / sponsor ID
- 18-261
- Conditions
- Stem Cell Transplant
- Keywords
- Cancer Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Posted 7 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient Palliative Care Intervention | Experimental | Other: 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) |
| Transplant Care Alone | Experimental | Other: Standard Transplant Care* Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent. * Standard Transplant Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative Care Interventionteam of clinicians that specialize in the lessening (palliation) of many distressing symptoms | Other | Inpatient Palliative Care Intervention |
| Standard Transplant CareStandard care per hospital guidelines | Other | Transplant Care Alone |
Primary outcome
Patient-reported Quality of Life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
Time frame: 2 weeks
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
9 secondary outcomes
Patients' Quality of Life (QOL) Longitudinally: FACT-BMT
Time frame: up to 6 months
Patients' Symptom Burden
Time frame: up to 6 months
Patients' Fatigue
Time frame: up to 6 months
Patients' Psychological Distress
Time frame: up to 6 months
Patients' Depression
Time frame: up to 6 months
Patients' Post-traumatic Stress Symptoms (PTSD)
Time frame: up to 6 months
Caregiver QOL: CARGOQOL
Time frame: up to 6 months
Caregiver Psychological Distress
Time frame: up to 6 months
Caregiver Depression
Time frame: up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40549982El-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.
- Derived from this study: PubMed 39908568Newcomb 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.
- Derived from this study: PubMed 38280483Yang 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.
- Derived from this study: PubMed 38181820Newcomb 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.
- Individual participant dataSharing planned: No
Related trials for Stem Cell Transplant
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Areej El-Jawahri, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care Intervention and Standard Transplant Care in people with Stem Cell Transplant, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported Quality of Life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03641378, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.