Trial Outcomes & Findings for Inpatient Palliative Care for Patients Undergoing Hematopoietic Stem Cell Transplantation (NCT NCT03641378)

Results Overview

Compare patient QOL using the Functional Assessment of Cancer Therapy- Bone Marrow Transplant (FACT-BMT) scores at week 2 between the study groups Score range 0-164 with higher score indicating better quality of life

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

546 participants

Primary outcome timeframe

2 weeks

Results posted on

2023-12-07

Participant Flow

Participant milestones

Participant milestones
Measure	Inpatient Palliative Care Intervention Patients * Patients will complete baseline self-report assessments at the time of obtaining informed consent * Palliative Care Intervention entails having patients seen by a palliative care clinician during their hospitalization for HCT at least twice weekly throughout the transplant hospitalization	Transplant Care Alone Patients * Patients will complete baseline self-report assessments at the time of obtaining informed consent. * Standard Transplant Care Standard Transplant Care: Standard care per hospital guidelines	Inpatient Palliative Care Caregivers Patients enrolled in the study and randomized to inpatient palliative care can identify a caregiver who is willing to participate in the study. Patients without an eligible caregiver are still eligible to participate. Caregivers will receive the palliative care intervention based on the patient assignment. Caregivers will be allowed to attend palliative care visits with the patients.	Transplant Care Alone Caregivers Caregivers of patients randomized to transplant care alone will receive standard transplant care offered by the hospital.
Overall Study STARTED	180	180	101	85
Overall Study COMPLETED	173	160	87	79
Overall Study NOT COMPLETED	7	20	14	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inpatient Palliative Care for Patients Undergoing Hematopoietic Stem Cell Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inpatient Palliative Care Intervention - Patients n=180 Participants * Patients will complete baseline self-report assessments at the time of obtaining informed consent * Patients randomized to the intervention will receive the palliative care intervention during their hospitalization for transplant in addition to standard transplant care. the palliative care intervention entails having palliative care clinicians see patients at least twice weekly during hospitalization for transplant.	Transplant Care Alone - Patients n=180 Participants * Patients will complete baseline self-report assessments at the time of obtaining informed consent. * Standard Transplant Care Standard Transplant Care: Standard care per hospital guidelines	Inpatient Palliative Care - Caregivers n=101 Participants \- Caregivers will be randomized based on the patient's randomization. they complete baseline assessment. if the patient is randomized to the palliative care intervention, the caregiver is also considered in this arm. they are permitted to attend the palliative care visits with the patients during hospitalization for transplant.	Transplant Care Alone- Caregivers n=85 Participants Caregivers complete baseline assessments and are randomized based on the random assignment of the patient. if the patient is randomized to standard transplant care, then the caregiver is randomized to standard transplant care.	Total n=546 Participants Total of all reporting groups
Age, Continuous	55.3 years n=5 Participants	55.5 years n=7 Participants	54.7 years n=5 Participants	55.1 years n=4 Participants	55.4 years n=21 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	65 Participants n=7 Participants	78 Participants n=5 Participants	67 Participants n=4 Participants	282 Participants n=21 Participants
Sex: Female, Male Male	108 Participants n=5 Participants	115 Participants n=7 Participants	23 Participants n=5 Participants	18 Participants n=4 Participants	264 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	3 Participants n=4 Participants	33 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants	15 Participants n=7 Participants	7 Participants n=5 Participants	3 Participants n=4 Participants	51 Participants n=21 Participants
Race (NIH/OMB) White	134 Participants n=5 Participants	142 Participants n=7 Participants	75 Participants n=5 Participants	74 Participants n=4 Participants	425 Participants n=21 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	11 Participants n=21 Participants

PRIMARY outcome

Timeframe: 2 weeks

Compare patient QOL using the Functional Assessment of Cancer Therapy- Bone Marrow Transplant (FACT-BMT) scores at week 2 between the study groups Score range 0-164 with higher score indicating better quality of life

Outcome measures

Outcome measures
Measure	Inpatient Palliative Care Intervention n=173 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent * Palliative Care Intervention * Therapeutic Relationship --Develop a strong therapeutic relationship with patients and caregivers * Assessment and Treatment of Patient Symptoms --Clarify the symptoms the patient will likely experience and offer reassurance about the methods for reporting and treating symptoms * Managing Patients and Caregivers Expectations --Address early on patients and caregivers' concerns about the trajectory of illness during HCT and treatment side effects * Coping with Illness and HCT --Introduce strategies to help improve adjustment (e.g., behavioral, cognitive, and spiritual approaches; accepting illness while maintaining hope; social support) Palliative Care Intervention: team of clinicians that specialize in the lessening (palliation) of many distressing symptoms	Transplant Care Alone n=160 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent. * Standard Transplant Care Standard Transplant Care: Standard care per hospital guidelines
Patient-reported Quality of Life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)	94.69 score on a scale Standard Deviation 22.5	90.09 score on a scale Standard Deviation 18.76

SECONDARY outcome

Timeframe: up to 6 months

Compare patients' QOL using Functional Assessment of Cancer Therapy- Bone Marrow Transplant (FACT-BMT) longitudinally between the study groups Score range 0-164, with higher score indicating better quality of life

Outcome measures

Outcome measures
Measure	Inpatient Palliative Care Intervention n=180 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent * Palliative Care Intervention * Therapeutic Relationship --Develop a strong therapeutic relationship with patients and caregivers * Assessment and Treatment of Patient Symptoms --Clarify the symptoms the patient will likely experience and offer reassurance about the methods for reporting and treating symptoms * Managing Patients and Caregivers Expectations --Address early on patients and caregivers' concerns about the trajectory of illness during HCT and treatment side effects * Coping with Illness and HCT --Introduce strategies to help improve adjustment (e.g., behavioral, cognitive, and spiritual approaches; accepting illness while maintaining hope; social support) Palliative Care Intervention: team of clinicians that specialize in the lessening (palliation) of many distressing symptoms	Transplant Care Alone n=180 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent. * Standard Transplant Care Standard Transplant Care: Standard care per hospital guidelines
Patients' Quality of Life (QOL) Longitudinally: FACT-BMT	107.8 score on a scale Standard Deviation 23.85	108.8 score on a scale Standard Deviation 19.64

SECONDARY outcome

Timeframe: up to 6 months

Population: at week-2

Compare patients' symptoms using the revised Edmonton Symptom Assessment Scale (ESAS) scores between the study groups score range 0-100 with higher score indicating worse symptom burden

Outcome measures

Outcome measures
Measure	Inpatient Palliative Care Intervention n=173 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent * Palliative Care Intervention * Therapeutic Relationship --Develop a strong therapeutic relationship with patients and caregivers * Assessment and Treatment of Patient Symptoms --Clarify the symptoms the patient will likely experience and offer reassurance about the methods for reporting and treating symptoms * Managing Patients and Caregivers Expectations --Address early on patients and caregivers' concerns about the trajectory of illness during HCT and treatment side effects * Coping with Illness and HCT --Introduce strategies to help improve adjustment (e.g., behavioral, cognitive, and spiritual approaches; accepting illness while maintaining hope; social support) Palliative Care Intervention: team of clinicians that specialize in the lessening (palliation) of many distressing symptoms	Transplant Care Alone n=160 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent. * Standard Transplant Care Standard Transplant Care: Standard care per hospital guidelines
Patients' Symptom Burden	35.63 score on a scale Standard Deviation 21.51	39.86 score on a scale Standard Deviation 20.83

SECONDARY outcome

Timeframe: up to 6 months

Population: week-2 analyses

Compare patients' fatigue using Functional Assessment of Cancer Therapy- Fatigue (FACT-fatigue) scores between the study groups score range from 0-52 with higher scores indicating lower fatigue symptoms

Outcome measures

Outcome measures
Measure	Inpatient Palliative Care Intervention n=171 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent * Palliative Care Intervention * Therapeutic Relationship --Develop a strong therapeutic relationship with patients and caregivers * Assessment and Treatment of Patient Symptoms --Clarify the symptoms the patient will likely experience and offer reassurance about the methods for reporting and treating symptoms * Managing Patients and Caregivers Expectations --Address early on patients and caregivers' concerns about the trajectory of illness during HCT and treatment side effects * Coping with Illness and HCT --Introduce strategies to help improve adjustment (e.g., behavioral, cognitive, and spiritual approaches; accepting illness while maintaining hope; social support) Palliative Care Intervention: team of clinicians that specialize in the lessening (palliation) of many distressing symptoms	Transplant Care Alone n=158 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent. * Standard Transplant Care Standard Transplant Care: Standard care per hospital guidelines
Patients' Fatigue	28.3 score on a scale Standard Deviation 12.65	25.96 score on a scale Standard Deviation 11.91

SECONDARY outcome

Timeframe: up to 6 months

Population: depression at week-2

Compare patients' depression and anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS) between the study groups The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)

Outcome measures

Outcome measures
Measure	Inpatient Palliative Care Intervention n=170 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent * Palliative Care Intervention * Therapeutic Relationship --Develop a strong therapeutic relationship with patients and caregivers * Assessment and Treatment of Patient Symptoms --Clarify the symptoms the patient will likely experience and offer reassurance about the methods for reporting and treating symptoms * Managing Patients and Caregivers Expectations --Address early on patients and caregivers' concerns about the trajectory of illness during HCT and treatment side effects * Coping with Illness and HCT --Introduce strategies to help improve adjustment (e.g., behavioral, cognitive, and spiritual approaches; accepting illness while maintaining hope; social support) Palliative Care Intervention: team of clinicians that specialize in the lessening (palliation) of many distressing symptoms	Transplant Care Alone n=160 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent. * Standard Transplant Care Standard Transplant Care: Standard care per hospital guidelines
Patients' Psychological Distress	6.17 score on a scale Standard Deviation 7.89	6.63 score on a scale Standard Deviation 4.20

SECONDARY outcome

Timeframe: up to 6 months

Population: depression (PHQ-9) by week-2

Compare patients' depression using Patient-Health Questionnaire - 9 (PHQ-9) between the study groups the PHQ-9 score ranges from 0-27, with higher score indicative more depressive symptoms

Outcome measures

Outcome measures
Measure	Inpatient Palliative Care Intervention n=169 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent * Palliative Care Intervention * Therapeutic Relationship --Develop a strong therapeutic relationship with patients and caregivers * Assessment and Treatment of Patient Symptoms --Clarify the symptoms the patient will likely experience and offer reassurance about the methods for reporting and treating symptoms * Managing Patients and Caregivers Expectations --Address early on patients and caregivers' concerns about the trajectory of illness during HCT and treatment side effects * Coping with Illness and HCT --Introduce strategies to help improve adjustment (e.g., behavioral, cognitive, and spiritual approaches; accepting illness while maintaining hope; social support) Palliative Care Intervention: team of clinicians that specialize in the lessening (palliation) of many distressing symptoms	Transplant Care Alone n=156 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent. * Standard Transplant Care Standard Transplant Care: Standard care per hospital guidelines
Patients' Depression	6.70 score on a scale Standard Deviation 5.20	7.07 score on a scale Standard Deviation 4.91

SECONDARY outcome

Timeframe: up to 6 months

Population: analyses at week-2

Compare patients' post-traumatic stress symptoms using the PTSD Checklist- Civilian version (PCL-C) between the study groups PCL-C score ranges from 17-85 with higher scores indicating worse PTSD symptoms

Outcome measures

Outcome measures
Measure	Inpatient Palliative Care Intervention n=168 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent * Palliative Care Intervention * Therapeutic Relationship --Develop a strong therapeutic relationship with patients and caregivers * Assessment and Treatment of Patient Symptoms --Clarify the symptoms the patient will likely experience and offer reassurance about the methods for reporting and treating symptoms * Managing Patients and Caregivers Expectations --Address early on patients and caregivers' concerns about the trajectory of illness during HCT and treatment side effects * Coping with Illness and HCT --Introduce strategies to help improve adjustment (e.g., behavioral, cognitive, and spiritual approaches; accepting illness while maintaining hope; social support) Palliative Care Intervention: team of clinicians that specialize in the lessening (palliation) of many distressing symptoms	Transplant Care Alone n=156 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent. * Standard Transplant Care Standard Transplant Care: Standard care per hospital guidelines
Patients' Post-traumatic Stress Symptoms (PTSD)	26.04 score on a scale Standard Deviation 9.37	28.17 score on a scale Standard Deviation 10.91

SECONDARY outcome

Timeframe: up to 6 months

Population: at week-2

Compare caregivers' QOL using caregiver oncology QOL questionnaire (CARGOQOL) scores between the study groups the caregiver oncology QOL questionnaire ranges from 0-116 with higher scores indicating better caregiver QOL.

Outcome measures

Outcome measures
Measure	Inpatient Palliative Care Intervention n=87 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent * Palliative Care Intervention * Therapeutic Relationship --Develop a strong therapeutic relationship with patients and caregivers * Assessment and Treatment of Patient Symptoms --Clarify the symptoms the patient will likely experience and offer reassurance about the methods for reporting and treating symptoms * Managing Patients and Caregivers Expectations --Address early on patients and caregivers' concerns about the trajectory of illness during HCT and treatment side effects * Coping with Illness and HCT --Introduce strategies to help improve adjustment (e.g., behavioral, cognitive, and spiritual approaches; accepting illness while maintaining hope; social support) Palliative Care Intervention: team of clinicians that specialize in the lessening (palliation) of many distressing symptoms	Transplant Care Alone n=79 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent. * Standard Transplant Care Standard Transplant Care: Standard care per hospital guidelines
Caregiver QOL: CARGOQOL	73.86 score on a scale Standard Deviation 12.88	73.51 score on a scale Standard Deviation 12.53

SECONDARY outcome

Timeframe: up to 6 months

Population: caregiver anxiety at week-2

Compare caregivers' psychological distress using hospital anxiety and depression scale (HADS) between the study groups the HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)

Outcome measures

Outcome measures
Measure	Inpatient Palliative Care Intervention n=87 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent * Palliative Care Intervention * Therapeutic Relationship --Develop a strong therapeutic relationship with patients and caregivers * Assessment and Treatment of Patient Symptoms --Clarify the symptoms the patient will likely experience and offer reassurance about the methods for reporting and treating symptoms * Managing Patients and Caregivers Expectations --Address early on patients and caregivers' concerns about the trajectory of illness during HCT and treatment side effects * Coping with Illness and HCT --Introduce strategies to help improve adjustment (e.g., behavioral, cognitive, and spiritual approaches; accepting illness while maintaining hope; social support) Palliative Care Intervention: team of clinicians that specialize in the lessening (palliation) of many distressing symptoms	Transplant Care Alone n=79 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent. * Standard Transplant Care Standard Transplant Care: Standard care per hospital guidelines
Caregiver Psychological Distress	6.82 score on a scale Standard Deviation 4.24	7.84 score on a scale Standard Deviation 9.13

SECONDARY outcome

Timeframe: up to 6 months

Population: week-2 caregiver depression (PHQ-9)

Compare caregivers' depression symptoms using the Patient Health Questionnaire - 9 (PHQ-9) between the study groups the PHQ-9 score ranges from 0-27 with higher scores indicating worse depression symptoms.

Outcome measures

Outcome measures
Measure	Inpatient Palliative Care Intervention n=87 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent * Palliative Care Intervention * Therapeutic Relationship --Develop a strong therapeutic relationship with patients and caregivers * Assessment and Treatment of Patient Symptoms --Clarify the symptoms the patient will likely experience and offer reassurance about the methods for reporting and treating symptoms * Managing Patients and Caregivers Expectations --Address early on patients and caregivers' concerns about the trajectory of illness during HCT and treatment side effects * Coping with Illness and HCT --Introduce strategies to help improve adjustment (e.g., behavioral, cognitive, and spiritual approaches; accepting illness while maintaining hope; social support) Palliative Care Intervention: team of clinicians that specialize in the lessening (palliation) of many distressing symptoms	Transplant Care Alone n=79 Participants * Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent. * Standard Transplant Care Standard Transplant Care: Standard care per hospital guidelines
Caregiver Depression	4.64 score on a scale Standard Deviation 4.54	4.73 score on a scale Standard Deviation 4.00

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 1 year

Other events: 0 other events

Deaths: 0 deaths

Inpatient Palliative Care Intervention Caregiver

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Transplant Care Alone Caregivers

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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place