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

N/ACompletedNCT02207322

Massachusetts General Hospital160 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

160

Conditions

Complication of Transplant

Interventions

transplant with early palliative careOTHER

the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Time frame: week-2

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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