Trial Outcomes & Findings for Supportive Care Intervention In Patients Hospitalized For Hematopoietic Stem Cell Transplantation (Shield) (NCT NCT02207322)

NCT ID: NCT02207322

Last Updated: 2024-10-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 160 participants
• Primary outcome timeframe: week-2
• Results posted on: 2024-10-17

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	79	81
Overall Study Week-2	77	80
Overall Study 3-month	74	75
Overall Study COMPLETED	70	71
Overall Study NOT COMPLETED	9	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Supportive Care Intervention In Patients Hospitalized For Hematopoietic Stem Cell Transplantation (Shield)

Baseline characteristics by cohort

Measure	Standard Transplant Care n=79 Participants * 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 n=81 Participants * 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	Total n=160 Participants Total of all reporting groups
Age, Continuous	56.9 years STANDARD_DEVIATION 14.1 • n=5 Participants	57.2 years STANDARD_DEVIATION 12.7 • n=7 Participants	57.1 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	48 Participants n=7 Participants	91 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	78 Participants n=5 Participants	78 Participants n=7 Participants	156 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=77 Participants * 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 n=80 Participants * 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
Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2	86.60 units on a scale Interval 82.0 to 91.2	94.33 units on a scale Interval 89.81 to 98.84

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=74 Participants * 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 n=75 Participants * 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
FACT-BMT Score at 3 Months	106.66 units on a scale Interval 102.91 to 110.41	112.00 units on a scale Interval 108.28 to 115.73

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=70 Participants * 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 n=71 Participants * 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
FACT-BMT Score at 6 Months	109.39 units on a scale Interval 105.38 to 113.41	112.11 units on a scale Interval 108.12 to 116.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=77 Participants * 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 n=80 Participants * 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
Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)	8.49 units on a scale Interval 7.59 to 9.39	6.74 units on a scale Interval 5.86 to 7.63

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=74 Participants * 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 n=74 Participants * 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
Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)	5.19 units on a scale Interval 4.45 to 5.93	3.49 units on a scale Interval 2.75 to 4.23

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=70 Participants * 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 n=71 Participants * 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
Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)	4.66 units on a scale Interval 3.93 to 5.38	3.45 units on a scale Interval 2.7 to 4.19

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=77 Participants * 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 n=80 Participants * 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
Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)	6.33 units on a scale Interval 5.64 to 7.02	4.08 units on a scale Interval 3.4 to 4.75

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=74 Participants * 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 n=74 Participants * 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
Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS)	4.84 units on a scale Interval 4.15 to 5.53	4.08 units on a scale Interval 3.39 to 4.78

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=72 Participants * 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 n=69 Participants * 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
Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS)	4.74 units on a scale Interval 3.99 to 5.49	4.13 units on a scale Interval 3.36 to 4.9

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=77 Participants * 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 n=80 Participants * 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
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2	9.52 units on a scale Interval 8.42 to 10.63	8.25 units on a scale Interval 7.16 to 9.33

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=74 Participants * 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 n=75 Participants * 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
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months	5.94 units on a scale Interval 5.02 to 6.86	3.82 units on a scale Interval 2.91 to 7.47

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=71 Participants * 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 n=71 Participants * 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
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months	5.58 units on a scale Interval 4.57 to 6.6	3.95 units on a scale Interval 2.93 to 4.98

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=77 Participants * 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 n=79 Participants * 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
Fatigue Scores (as Measured by FACT-Fatigue) at Week-2	23.71 units on a scale Interval 21.11 to 26.31	27.59 units on a scale Interval 25.01 to 30.16

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=74 Participants * 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 n=73 Participants * 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
Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months	35.60 units on a scale Interval 33.43 to 37.77	37.60 units on a scale Interval 35.42 to 39.79

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=77 Participants * 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 n=75 Participants * 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
Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2	37.74 units on a scale Interval 34.09 to 41.4	31.49 units on a scale Interval 27.79 to 35.19

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=67 Participants * 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 n=72 Participants * 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
Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months	25.79 units on a scale Interval 23.79 to 27.79	21.44 units on a scale Interval 19.53 to 23.35

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=71 Participants * 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 n=68 Participants * 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
Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months	26.18 units on a scale Interval 23.96 to 28.39	22.15 units on a scale Interval 19.91 to 24.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=40 Participants * 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 n=46 Participants * 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
Caregiver Quality of Life	113.32 units on a scale Interval 107.79 to 118.85	118.71 units on a scale Interval 114.4 to 123.03

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Standard Transplant Care n=42 Participants * 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 n=46 Participants * 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
Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS)	6 units on a scale Interval 4.51 to 7.49	4.05 units on a scale Interval 3.01 to 5.1

OTHER_PRE_SPECIFIED outcome

Timeframe: week 2

compare caregiver anxiety at week-2 using hospital anxiety and depression scale (HADS)

Outcome measures

Measure	Standard Transplant Care n=42 Participants * 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 n=46 Participants * 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
Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS)	6.54 units on a scale Interval 5.09 to 7.99	6.24 units on a scale Interval 5.1 to 7.37

Adverse Events

Standard Transplant Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Transplant With Early Palliative Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Areej El-Jawahri

Massachusetts General Hospital

Phone: 617-724-4000

Email: ael-jawahri@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place