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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02207322
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Actual Duration (Months): 36
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complication of Transplant	Other: transplant with early palliative care	N/A

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

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Randomized Study of a Targeted Inpatient Supportive Care Intervention in Patients Hospitalized for Hematopoietic Stem Cell Transplantation (HSCT)
• Actual Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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
Experimental: 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	Other: 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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

Other Outcome Measures

1. 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

2. 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

3. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Jennifer S Temel, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: El-Jawahri, Areej,M.D., Director MGH BMT Survivorship Program, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02207322
• Other Study ID Numbers: 14-241
• First Posted: Aug 4, 2014
• Last Update Posted: Mar 6, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by El-Jawahri, Areej,M.D., Director MGH BMT Survivorship Program, Massachusetts General Hospital: Hematopoietic stem cell transplantation (HSCT); autologous stem cell transplant; allogeneic stem cell transplant

Study Results

Participant Flow

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	79	81
Week-2	77	80
3-month	74	75
COMPLETED	70	71
NOT COMPLETED	9	10

Baseline Characteristics

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	79	81	160
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.9 (14.1)	57.2 (12.7)	57.1 (13.3)
Sex: Female, Male (Count of Participants)
Female	43 54.4%	48 59.3%	91 56.9%
Male	36 45.6%	33 40.7%	69 43.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 1.3%	3 3.7%	4 2.5%
Not Hispanic or Latino	78 98.7%	78 96.3%	156 97.5%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	77	80
Mean (95% Confidence Interval) [units on a scale]	86.60	94.33

2. Secondary Outcome

Title	FACT-BMT Score at 3 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	74	75
Mean (95% Confidence Interval) [units on a scale]	106.66	112.00

3. Secondary Outcome

Title	FACT-BMT Score at 6 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	70	71
Mean (95% Confidence Interval) [units on a scale]	109.39	112.11

4. Secondary Outcome

Title	Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	77	80
Mean (95% Confidence Interval) [units on a scale]	8.49	6.74

5. Secondary Outcome

Title	Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	74	74
Mean (95% Confidence Interval) [units on a scale]	5.19	3.49

6. Secondary Outcome

Title	Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	70	71
Mean (95% Confidence Interval) [units on a scale]	4.66	3.45

7. Secondary Outcome

Title	Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	77	80
Mean (95% Confidence Interval) [units on a scale]	6.33	4.08

8. Secondary Outcome

Title	Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	74	74
Mean (95% Confidence Interval) [units on a scale]	4.84	4.08

9. Secondary Outcome

Title	Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	72	69
Mean (95% Confidence Interval) [units on a scale]	4.74	4.13

10. Secondary Outcome

Title	Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	77	80
Mean (95% Confidence Interval) [units on a scale]	9.52	8.25

11. Secondary Outcome

Title	Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	74	75
Mean (95% Confidence Interval) [units on a scale]	5.94	3.82

12. Secondary Outcome

Title	Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	71	71
Mean (95% Confidence Interval) [units on a scale]	5.58	3.95

13. Secondary Outcome

Title	Fatigue Scores (as Measured by FACT-Fatigue) at Week-2
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	77	79
Mean (95% Confidence Interval) [units on a scale]	23.71	27.59

14. Secondary Outcome

Title	Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	74	73
Mean (95% Confidence Interval) [units on a scale]	35.60	37.60

15. Secondary Outcome

Title	Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	77	75
Mean (95% Confidence Interval) [units on a scale]	37.74	31.49

16. Secondary Outcome

Title	Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	67	72
Mean (95% Confidence Interval) [units on a scale]	25.79	21.44

17. Secondary Outcome

Title	Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	71	68
Mean (95% Confidence Interval) [units on a scale]	26.18	22.15

18. Other Pre-specified Outcome

Title	Caregiver Quality of Life
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	40	46
Mean (95% Confidence Interval) [units on a scale]	113.32	118.71

19. Other Pre-specified Outcome

Title	Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	42	46
Mean (95% Confidence Interval) [units on a scale]	6	4.05

20. Other Pre-specified Outcome

Title	Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS)
Description	compare caregiver anxiety at week-2 using hospital anxiety and depression scale (HADS)
Time Frame	week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Transplant Care	Transplant With Early Palliative Care
Arm/Group Description	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	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
Measure Participants	42	46
Mean (95% Confidence Interval) [units on a scale]	6.54	6.24

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	this is a supportive care trial. there are no adverse events that have been observed
Arm/Group Title	Standard Transplant Care		Transplant With Early Palliative Care
Arm/Group Description	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		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
All Cause Mortality
	Standard Transplant Care		Transplant With Early Palliative Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Transplant Care		Transplant With Early Palliative Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/79 (0%)		0/81 (0%)
Other (Not Including Serious) Adverse Events
	Standard Transplant Care		Transplant With Early Palliative Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/79 (0%)		0/81 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.