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

Randomized Study of a Targeted Inpatient Supportive Care Intervention in Patients Hospitalized for Hematopoietic Stem Cell Transplantation (HSCT)

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.

Study Overview

• Status: Completed
• Conditions: Complication of Transplant
• Intervention / Treatment: Other: transplant with early palliative care

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 hospitalization3-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 hospitalization3-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2	Compare quality of life (QOL) (FACT-BMT) scores at week-2 (day+5 for autologous, day +8 for myeloablative or reduced intensity allogeneic HSCT) adjusting for baseline QOL scores between the study arms. Score range 0-164 with higher scores indicating better quality of life	week-2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FACT-BMT Score at 3 Months	adjusted patient-reported quality of life (QOL) at 3-month adjusting for baseline QOL scores Score range 0-164 with higher scores indicating better quality of life	3 months
FACT-BMT Score at 6 Months	compare quality of life between the two study arms at 6 months adjusting for baseline scores Score range 0-164 with higher scores indicating better quality of life	6 Months
Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)	compare depression symptoms using HADS at week-2 adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms	week-2
Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)	compare depression symptoms using HADS at 3 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms	3 month
Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)	Compare depression symptoms using HADS at 6 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms	6 months
Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)	compare anxiety symptoms using HADS at week-2 adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms	week-2
Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS)	compare anxiety symptoms using HADS at 3 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms	3 months
Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS)	compare anxiety symptoms using HADS at 6 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms	6 months
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2	compare PHQ-9 score at week-2 between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression	week 2
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months	compare PHQ-9 score at 3-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression	3-month
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months	compare PHQ-9 score at 6-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression	6-month
Fatigue Scores (as Measured by FACT-Fatigue) at Week-2	examine change in fatigue scores at week-2 adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms	week-2
Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months	compare change in fatigue scores at 3 months adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms	3-months
Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2	compare symptom burden as measured by Edmonton Symptom Assessment Scale at week-2 adjusting for baseline scores Symptoms burden range is from 0-90 with higher scores indicating higher symptom burden	week-2
Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months	Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 3 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms	3-months
Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months	Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 6 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms	6-months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Quality of Life	we will use the CareGiver Oncology QOL questionnaire (CarGOQOL) to compare caregiver QOL at week-2 between the study arms caregiver quality of life score ranges from 0-120 with higher scores indicating better caregiver quality of life	week-2
Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS)	compare caregiver depression at week-2 using hospital anxiety and depression scale (HADS) caregiver depression score ranges from 0-21 with higher score indicating higher depression symptoms	week 2
Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS)	compare caregiver anxiety at week-2 using hospital anxiety and depression scale (HADS)	week 2

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• El-Jawahri A, LeBlanc T, VanDusen H, Traeger L, Greer JA, Pirl WF, Jackson VA, Telles J, Rhodes A, Spitzer TR, McAfee S, Chen YA, Lee SS, Temel JS. Effect of Inpatient Palliative Care on Quality of Life 2 Weeks After Hematopoietic Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2016 Nov 22;316(20):2094-2103. doi: 10.1001/jama.2016.16786.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: July 31, 2014
• First Posted (Estimated): August 4, 2014

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: autologous stem cell transplant; allogeneic stem cell transplant; Hematopoietic stem cell transplantation (HSCT)
• Other Study ID Numbers: 14-241