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

Mass General Brigham

Status: Completed

Conditions: Complication of Transplant

Treatments: Other: transplant with early palliative care

Study type: Interventional

Funder types: Other

Identifiers

NCT02207322

14-241

Details and patient eligibility

About

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.

Full 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

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Standard transplant care

No Intervention group

Description:

* 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

Experimental group

Description:

* 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

Treatment:

Other: transplant with early palliative care