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

Not Applicable

Completed

Conditions: Complication of Transplant

Interventions: Other: transplant with early palliative care

Registration Number: NCT02207322

Lead Sponsor: Massachusetts General Hospital

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 160

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transplant with early palliative care	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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