Randomized Study of a Targeted Inpatient Supportive Care Intervention in Patients Hospitalized for Hematopoietic Stem Cell Transplantation (HSCT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2
Study Overview
Brief Summary
The main purpose of this study is to assess whether early integration of palliative and supportive care services in care of patients hospitalized for hematopoietic stem cell transplantation (HSCT) can improve patients' and family caregivers' quality of life and mood.
Detailed Description
This research study is evaluating the impact of early involvement of supportive care team working with the transplant oncology team will have on the quality of life, symptoms, and mood of patients undergoing stem cell transplantation.
The purpose of this research study is to find out whether introducing patients and families undergoing stem cell transplantation to the palliative care team that specializes in symptom management can improve the physical and psychological symptoms that patients and families experience during hospitalization for stem cell transplantation.
The study will use a series of questionnaires to measure participant's and their caregivers' quality of life, physical symptoms, and mood. Study questionnaires will be completed in the hospital or clinic with assistance provided as needed
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
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
Intervention: transplant with early palliative care (Other)
Outcomes
Primary Outcomes
Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2
Time Frame: 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 Outcomes
- Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months(3-month)
- Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months(6-month)
- FACT-BMT Score at 3 Months(3 months)
- FACT-BMT Score at 6 Months(6 Months)
- Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)(week-2)
- Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)(6 months)
- Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)(3 month)
- Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS)(6 months)
- Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2(week 2)
- Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)(week-2)
- Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS)(3 months)
- Fatigue Scores (as Measured by FACT-Fatigue) at Week-2(week-2)
- Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months(3-months)
- Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2(week-2)
- Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months(6-months)
- Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months(3-months)
Investigators
El-Jawahri, Areej,M.D.
Director MGH BMT Survivorship Program
Massachusetts General Hospital