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

NCT02207322 | Completed Results DMC

• 1 other identifier: 14-241
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication of Transplant

Keywords

Hematopoietic stem cell transplantation (HSCT); autologous stem cell transplant; allogeneic stem cell transplant

Outcome Measures

Primary Outcomes (1)

• 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

  week-2

Secondary Outcomes (16)

• FACT-BMT Score at 3 Months

  3 months

• FACT-BMT Score at 6 Months

  6 Months

• Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)

  week-2

• Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)

  3 month

• Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)

  6 months

Other Outcomes (3)

• Caregiver Quality of Life

  week-2

• Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS)

  week 2

• Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS)

  week 2

Study Arms (2)

Standard transplant care

NO INTERVENTION

* 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

* 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

Other: transplant with early palliative care

Interventions

transplant with early palliative care OTHER

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

transplant with early palliative care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• 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.

  PMID: 39908568 DERIVED

• 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.

  PMID: 27893130 DERIVED

MeSH Terms

Interventions

Transplantation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Results Point of Contact

• Title: Areej El-Jawahri
• Organization: Massachusetts General Hospital

ael-jawahri@partners.org

617-724-4000

Study Officials

• Areej El-Jawahri, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director MGH BMT Survivorship Program

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 4, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2017
• Last Updated: October 17, 2024
• Results First Posted: March 6, 2019

Record last verified: 2024-10

Locations

US (1)