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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard transplant care | No Intervention |
| |
| transplant with early palliative care | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transplant with early palliative care | Other | the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | week-2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| FACT-BMT Score at 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Quality of Life | we will use the CareGiver Oncology QOL questionnaire (CarGOQOL) to compare caregiver QOL at week-2 between the study arms caregiver quality of life score ranges from 0-120 with higher scores indicating better caregiver quality of life | week-2 |
| Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS) |
Inclusion Criteria:
Patients Eligibility Criteria:
Caregivers Eligibility Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Areej El-Jawahri, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39908568 | Derived | 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. | |
| 27893130 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Transplant Care |
|
| FG001 | Transplant With Early Palliative Care |
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Transplant Care |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | week-2 |
|
1 year
this is a supportive care trial. there are no adverse events that have been observed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Transplant Care |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Areej El-Jawahri | Massachusetts General Hospital | 617-724-4000 | ael-jawahri@partners.org |
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| ID | Term |
|---|---|
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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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
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 6-months |
compare caregiver depression at week-2 using hospital anxiety and depression scale (HADS) caregiver depression score ranges from 0-21 with higher score indicating higher depression symptoms |
| week 2 |
| Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS) | compare caregiver anxiety at week-2 using hospital anxiety and depression scale (HADS) | week 2 |
| El-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. |
| BG001 | Transplant With Early Palliative Care |
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Transplant With Early Palliative Care |
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation |
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 6 Months |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | week-2 |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 3 month |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | week-2 |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | week 2 |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 3-month |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 6-month |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | week-2 |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 3-months |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | week-2 |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 3-months |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 6-months |
|
|
|
| Other Pre-specified | Caregiver Quality of Life | we will use the CareGiver Oncology QOL questionnaire (CarGOQOL) to compare caregiver QOL at week-2 between the study arms caregiver quality of life score ranges from 0-120 with higher scores indicating better caregiver quality of life | Posted | Mean | 95% Confidence Interval | units on a scale | week-2 |
|
|
|
| Other Pre-specified | Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS) | compare caregiver depression at week-2 using hospital anxiety and depression scale (HADS) caregiver depression score ranges from 0-21 with higher score indicating higher depression symptoms | Posted | Mean | 95% Confidence Interval | units on a scale | week 2 |
|
|
|
| Other Pre-specified | Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS) | compare caregiver anxiety at week-2 using hospital anxiety and depression scale (HADS) | Posted | Mean | 95% Confidence Interval | units on a scale | week 2 |
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | Transplant With Early Palliative Care |
transplant with early palliative care: the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation | 0 | 81 | 0 | 81 |
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