Clinical trial NCT02207322: Supportive Care Intervention In Patients Hospitalized For Hematopoietic Stem Cell Transplantation (Shield)
Official title: Randomized Study of a Targeted Inpatient Supportive Care Intervention in Patients Hospitalized for Hematopoietic Stem Cell Transplantation (HSCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complication of Transplant
Keywords: Hematopoietic stem cell transplantation (HSCT)
autologous stem cell transplant
allogeneic stem cell transplant
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2
timeFrame: week-2
Secondary outcomes:
measure: FACT-BMT Score at 3 Months
timeFrame: 3 months
measure: FACT-BMT Score at 6 Months
timeFrame: 6 Months
measure: Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: week-2
measure: Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 month
measure: Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months
measure: Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: week-2
measure: Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 months
measure: Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months
measure: Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2
timeFrame: week 2
measure: Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months
timeFrame: 3-month
measure: Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months
timeFrame: 6-month
measure: Fatigue Scores (as Measured by FACT-Fatigue) at Week-2
timeFrame: week-2
measure: Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months
timeFrame: 3-months
measure: Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2
timeFrame: week-2
measure: Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months
timeFrame: 3-months
measure: Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months
timeFrame: 6-months
Other outcomes:
measure: Caregiver Quality of Life
timeFrame: week-2
measure: Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS)
timeFrame: week 2
measure: Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS)
timeFrame: week 2
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.