Complication of Transplant
Conditions
Keywords
Hematopoietic stem cell transplantation (HSCT), autologous stem cell transplant, allogeneic stem cell transplant
Brief 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.
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
Interventions
OTHERtransplant 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
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS) | 6 months | 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 |
| Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2 | 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 |
| Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months | 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 |
| Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months | 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 |
| FACT-BMT Score at 3 Months | 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 |
| FACT-BMT Score at 6 Months | 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 |
| Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS) | week-2 | 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 |
| Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS) | 3 month | 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 |
| Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS) | 6 months | 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 |
| Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS) | week-2 | 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 |
| Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS) | 3 months | 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 |
| Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2 | 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 |
| Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months | 3-month | 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 |
| Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months | 6-month | 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 |
| Fatigue Scores (as Measured by FACT-Fatigue) at Week-2 | 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 |
| Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS) | week 2 | compare caregiver anxiety at week-2 using hospital anxiety and depression scale (HADS) |
| Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS) | week 2 | 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 |
| Caregiver Quality of Life | week-2 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Transplant Care * 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 | 79 |
| 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
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 | 81 |
| Total | 160 |
Baseline characteristics
| Characteristic | Standard Transplant Care | Transplant With Early Palliative Care | Total |
|---|---|---|---|
| Age, Continuous | 56.9 years STANDARD_DEVIATION 14.1 | 57.2 years STANDARD_DEVIATION 12.7 | 57.1 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants | 78 Participants | 156 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 43 Participants | 48 Participants | 91 Participants |
| Sex: Female, Male Male | 36 Participants | 33 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 79 | 0 / 81 |
| serious Total, serious adverse events | 0 / 79 | 0 / 81 |
Outcome results
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
Time frame: week-2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2 | 86.60 units on a scale |
| Transplant With Early Palliative Care | Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2 | 94.33 units on a scale |
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS) | 4.84 units on a scale |
| Transplant With Early Palliative Care | Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS) | 4.08 units on a scale |
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS) | 4.74 units on a scale |
| Transplant With Early Palliative Care | Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS) | 4.13 units on a scale |
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
Time frame: week-2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS) | 6.33 units on a scale |
| Transplant With Early Palliative Care | Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS) | 4.08 units on a scale |
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
Time frame: 3-month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months | 5.94 units on a scale |
| Transplant With Early Palliative Care | Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months | 3.82 units on a scale |
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
Time frame: 6-month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months | 5.58 units on a scale |
| Transplant With Early Palliative Care | Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months | 3.95 units on a scale |
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
Time frame: week 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2 | 9.52 units on a scale |
| Transplant With Early Palliative Care | Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2 | 8.25 units on a scale |
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
Time frame: 3 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS) | 5.19 units on a scale |
| Transplant With Early Palliative Care | Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS) | 3.49 units on a scale |
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS) | 4.66 units on a scale |
| Transplant With Early Palliative Care | Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS) | 3.45 units on a scale |
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
Time frame: week-2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS) | 8.49 units on a scale |
| Transplant With Early Palliative Care | Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS) | 6.74 units on a scale |
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | FACT-BMT Score at 3 Months | 106.66 units on a scale |
| Transplant With Early Palliative Care | FACT-BMT Score at 3 Months | 112.00 units on a scale |
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
Time frame: 6 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | FACT-BMT Score at 6 Months | 109.39 units on a scale |
| Transplant With Early Palliative Care | FACT-BMT Score at 6 Months | 112.11 units on a scale |
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
Time frame: 3-months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months | 35.60 units on a scale |
| Transplant With Early Palliative Care | Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months | 37.60 units on a scale |
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
Time frame: week-2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Fatigue Scores (as Measured by FACT-Fatigue) at Week-2 | 23.71 units on a scale |
| Transplant With Early Palliative Care | Fatigue Scores (as Measured by FACT-Fatigue) at Week-2 | 27.59 units on a scale |
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
Time frame: 3-months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months | 25.79 units on a scale |
| Transplant With Early Palliative Care | Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months | 21.44 units on a scale |
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
Time frame: 6-months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months | 26.18 units on a scale |
| Transplant With Early Palliative Care | Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months | 22.15 units on a scale |
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
Time frame: week-2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2 | 37.74 units on a scale |
| Transplant With Early Palliative Care | Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2 | 31.49 units on a scale |
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)
Time frame: week 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS) | 6.54 units on a scale |
| Transplant With Early Palliative Care | Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS) | 6.24 units on a scale |
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
Time frame: week 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS) | 6 units on a scale |
| Transplant With Early Palliative Care | Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS) | 4.05 units on a scale |
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
Time frame: week-2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Transplant Care | Caregiver Quality of Life | 113.32 units on a scale |
| Transplant With Early Palliative Care | Caregiver Quality of Life | 118.71 units on a scale |