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

NCT ID: NCT02207322

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-08-31

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

Conditions

Complication of Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

transplant with early palliative care

Intervention Type: OTHER

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

Interventions

transplant with early palliative care

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

El-Jawahri, Areej,M.D.

Director MGH BMT Survivorship Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Areej El-Jawahri, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Newcomb R, Amonoo HL, Kavanaugh AR, Wharton KC, Rowland M, Fausto J, Webb J, Jackson V, Greer JA, Temel JS, Lark P, Rabideau DJ, O'Brien K, LeBlanc TW, Lee SJ, El-Jawahri A. Factors associated with early quality-of-life response to palliative care during hematopoietic cell transplantation. Blood Adv. 2025 May 13;9(9):2033-2043. doi: 10.1182/bloodadvances.2024014574.

Reference Type: DERIVED

PMID: 39908568 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27893130 (View on PubMed)

Other Identifiers

14-241

Identifier Type: -

Identifier Source: org_study_id