Complication of TransplantSHIELDNCT02207322
Supportive Care Intervention In Patients Hospitalized For Hematopoietic Stem Cell Transplantation (Shield)
A study testing transplant with early palliative care in people with Complication of Transplant, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The main purpose of this study is to assess whether early integration of palliative and supportive care services in care of patients hospitalized for hematopoietic stem cell transplantation (HSCT) can improve patients' and family caregivers' quality of life and mood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complication of Transplant
- What is being tested?
- transplant with early palliative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Aug 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients Eligibility Criteria:
- Adult patients (≥18 years) with hematologic malignancy admitted to Massachusetts General Hospital for HSCT are eligible for the study.
- Ability to speak English or able to complete questionnaires with minimal assistance required from an interpreter or family member.
- Caregivers Eligibility Criteria:
- Adult caregivers (>18 years) of patients undergoing HSCT at MGH who agreed to participate in study.
- A relative or a friend, identified by the patient who either lives with the patient or has in-person contact with him or her at least twice per week.
- Ability to read questions in English or willing to complete questionnaires with the assistance of an interpreter.
Who cannot join
- Patients with prior history of HSCT.
- Patients undergoing HSCT for a benign hematologic condition (myelodysplastic syndrome (MDS) is not considered a benign hematologic condition and patients with MDS are eligible for the study)
- Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits informed consent or participation in the study.
- Patients enrolled on other supportive care intervention trials.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Randomized Study of a Targeted Inpatient Supportive Care Intervention in Patients Hospitalized for Hematopoietic Stem Cell Transplantation (HSCT)
The main purpose of this study is to assess whether early integration of palliative and supportive care services in care of patients hospitalized for hematopoietic stem cell transplantation (HSCT) can improve patients' and family caregivers' quality of life and mood.
Read the detailed description
This research study is evaluating the impact of early involvement of supportive 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 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 participant's and their caregivers' quality of life, physical symptoms, and mood. Study questionnaires will be completed in the hospital or clinic with assistance provided as needed
- Conditions
- Complication of Transplant
- Being tested
- transplant with early palliative care
- Keywords
- Hematopoietic stem cell transplantation (HSCT), autologous stem cell transplant, allogeneic stem cell transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transplant with early palliative careOther
the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Standard transplant care | No intervention | * Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital) -- Complete baseline data collection, and registration * Patient Randomization * Standard transplant oncology care -- Palliative care consults only upon request * Longitudinal Data Collection (patient \& family caregivers) * Week-2 of hospitalization * 3-months, and 6-months post HSCT |
| transplant with early palliative care | Experimental | * Standard transplant oncology care with early palliative care
* Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment)
--Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits
* Longitudinal Data Collection (patient \& family caregivers)
* Week-2 of hospitalization
* 3-months, and 6-months post HSCT Receives: Other: transplant with early palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2
Compare quality of life (QOL) (FACT-BMT) scores at week-2 (day+5 for autologous, day +8 for myeloablative or reduced intensity allogeneic HSCT) adjusting for baseline QOL scores between the study arms. Score range 0-164 with higher scores indicating better quality of life
Measured: week-2
Secondary outcomes (16)
FACT-BMT Score at 3 Months
adjusted patient-reported quality of life (QOL) at 3-month adjusting for baseline QOL scores Score range 0-164 with higher scores indicating better quality of life
Measured: 3 months
FACT-BMT Score at 6 Months
compare quality of life between the two study arms at 6 months adjusting for baseline scores Score range 0-164 with higher scores indicating better quality of life
Measured: 6 Months
Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)
compare depression symptoms using HADS at week-2 adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms
Measured: week-2
Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)
compare depression symptoms using HADS at 3 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms
Measured: 3 month
Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)
Compare depression symptoms using HADS at 6 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms
Measured: 6 months
Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)
compare anxiety symptoms using HADS at week-2 adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms
Measured: week-2
Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS)
compare anxiety symptoms using HADS at 3 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms
Measured: 3 months
Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS)
compare anxiety symptoms using HADS at 6 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms
Measured: 6 months
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2
compare PHQ-9 score at week-2 between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression
Measured: week 2
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months
compare PHQ-9 score at 3-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression
Measured: 3-month
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months
compare PHQ-9 score at 6-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression
Measured: 6-month
Fatigue Scores (as Measured by FACT-Fatigue) at Week-2
examine change in fatigue scores at week-2 adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms
Measured: week-2
Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months
compare change in fatigue scores at 3 months adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms
Measured: 3-months
Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2
compare symptom burden as measured by Edmonton Symptom Assessment Scale at week-2 adjusting for baseline scores Symptoms burden range is from 0-90 with higher scores indicating higher symptom burden
Measured: week-2
Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months
Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 3 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms
Measured: 3-months
Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months
Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 6 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2016
- Study completionAug 2017
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 (2)Papers the sponsor has linked to this study.
- Other trials for Complication of 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- 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
- NCT02207322
- Sponsor's protocol ID
- 14-241
- Acronym
- SHIELD
- Status last verified
- Oct 2024
- First submitted
- 31 Jul 2014
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 39908568El-Jawahri A, LeBlanc T, VanDusen H, Traeger L, Greer JA, Pirl WF, Jackson VA, Telles J, Rhodes A, Spitzer TR, McAfee S, Chen YA, Lee SS, Temel JS. Effect of Inpatient Palliative Care on Quality of Life 2 Weeks After Hematopoietic Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2016 Nov 22;316(20):2094-2103. doi: 10.1001/jama.2016.16786.
PubMed 27893130
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of a Targeted Inpatient Supportive Care Intervention in Patients Hospitalized for Hematopoietic Stem Cell Transplantation (HSCT)
- ClinicalTrials.gov ID
- NCT02207322
- Acronym / sponsor ID
- SHIELD / 14-241
- Conditions
- Complication of Transplant
- Keywords
- Hematopoietic stem cell transplantation (HSCT), autologous stem cell transplant, allogeneic stem cell transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Posted 6 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess whether early integration of palliative and supportive care services in care of patients hospitalized for hematopoietic stem cell transplantation (HSCT) can improve patients' and family caregivers' quality of life and mood.
Detailed description
This research study is evaluating the impact of early involvement of supportive 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 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 participant's and their caregivers' quality of life, physical symptoms, and mood. Study questionnaires will be completed in the hospital or clinic with assistance provided as needed
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard transplant care | No intervention | –* Patient Enrollment and Caregiver Enrollment (within 72 hours of hospital) -- Complete baseline data collection, and registration * Patient Randomization * Standard transplant oncology care -- Palliative care consults only upon request * Longitudinal Data Collection (patient \& family caregivers) * Week-2 of hospitalization * 3-months, and 6-months post HSCT |
| transplant with early palliative care | Experimental | Other: transplant with early palliative care* Standard transplant oncology care with early palliative care * Patient Enrollment and Caregiver Enrollment (within 72 hours of patient enrollment) --Complete baseline data collection, and registration Intervention description: Inpatient palliative care intervention description: 1st visit within 72 hours of randomization, At least twice weekly follow up visits * Longitudinal Data Collection (patient \& family caregivers) * Week-2 of hospitalization * 3-months, and 6-months post HSCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients Eligibility Criteria:
- Caregivers Eligibility Criteria:
Key exclusion criteria (4 listed)
- Patients with prior history of HSCT.
- Patients undergoing HSCT for a benign hematologic condition (myelodysplastic syndrome (MDS) is not considered a benign hematologic condition and patients with MDS are eligible for the study)
- Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits informed consent or participation in the study.
- Patients enrolled on other supportive care intervention trials.
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 |
|---|---|---|
| transplant with early palliative carethe intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation | Other | transplant with early palliative care |
Primary outcome
Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2
Time frame: week-2
Compare quality of life (QOL) (FACT-BMT) scores at week-2 (day+5 for autologous, day +8 for myeloablative or reduced intensity allogeneic HSCT) adjusting for baseline QOL scores between the study arms. Score range 0-164 with higher scores indicating better quality of life
16 secondary outcomes
FACT-BMT Score at 3 Months
Time frame: 3 months
FACT-BMT Score at 6 Months
Time frame: 6 Months
Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)
Time frame: week-2
Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 month
Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months
Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)
Time frame: week-2
Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 months
Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2
Time frame: week 2
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months
Time frame: 3-month
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months
Time frame: 6-month
Fatigue Scores (as Measured by FACT-Fatigue) at Week-2
Time frame: week-2
Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months
Time frame: 3-months
Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2
Time frame: week-2
Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months
Time frame: 3-months
Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months
Time frame: 6-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 27893130El-Jawahri A, LeBlanc T, VanDusen H, Traeger L, Greer JA, Pirl WF, Jackson VA, Telles J, Rhodes A, Spitzer TR, McAfee S, Chen YA, Lee SS, Temel JS. Effect of Inpatient Palliative Care on Quality of Life 2 Weeks After Hematopoietic Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2016 Nov 22;316(20):2094-2103. doi: 10.1001/jama.2016.16786.
Related trials for Complication of Transplant
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transplant with early palliative care in people with Complication of Transplant, run by Massachusetts General Hospital at 1 site 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 7 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 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 6 Mar 2019). 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?
Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2 (time frame: week-2). 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 NCT02207322, which also lists 2 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 17 Oct 2024.