Inpatient Palliative Care for Patients Undergoing Hematopoietic Stem Cell Transplantation

NCT03641378 | Completed Results

• 2 other identifiers: 18-261R01CA222014
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 3

Brief Summary

This research study is evaluating the impact of early involvement of a palliative care team working with the transplant oncology team will have on the quality of life, symptoms, and mood of patients undergoing stem cell transplantation.

Conditions

Stem Cell Transplant

Keywords

Cancer Care

Outcome Measures

Primary Outcomes (1)

• Patient-reported Quality of Life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)

  Compare patient QOL using the Functional Assessment of Cancer Therapy- Bone Marrow Transplant (FACT-BMT) scores at week 2 between the study groups Score range 0-164 with higher score indicating better quality of life

  2 weeks

Secondary Outcomes (9)

• Patients' Quality of Life (QOL) Longitudinally: FACT-BMT

  up to 6 months

• Patients' Symptom Burden

  up to 6 months

• Patients' Fatigue

  up to 6 months

• Patients' Psychological Distress

  up to 6 months

• Patients' Depression

  up to 6 months

Other Outcomes (4)

• Patient Coping

  up to 1 year

• Caregiver Coping

  up to 1 year

• Mediation Analysis (Symptom Burden and Coping) as Mediators of Improvement in Patient-reported QOL

  2 week

Study Arms (2)

Inpatient Palliative Care Intervention

EXPERIMENTAL

* Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent * Palliative Care Intervention * Therapeutic Relationship --Develop a strong therapeutic relationship with patients and caregivers * Assessment and Treatment of Patient Symptoms --Clarify the symptoms the patient will likely experience and offer reassurance about the methods for reporting and treating symptoms * Managing Patients and Caregivers Expectations --Address early on patients and caregivers' concerns about the trajectory of illness during HCT and treatment side effects * Coping with Illness and HCT --Introduce strategies to help improve adjustment (e.g., behavioral, cognitive, and spiritual approaches; accepting illness while maintaining hope; social support)

Other: Palliative Care Intervention

Transplant Care Alone

EXPERIMENTAL

* Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent. * Standard Transplant Care

Other: Standard Transplant Care

Interventions

Palliative Care Intervention OTHER

team of clinicians that specialize in the lessening (palliation) of many distressing symptoms

Inpatient Palliative Care Intervention

Standard Transplant Care OTHER

Standard care per hospital guidelines

Transplant Care Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients (≥ 18 years) with hematologic malignancy admitted for autologous or allogeneic HCT.
• ability to read and respond to questions in English or Spanish or to complete questionnaires with assistance from an interpreter.
• Caregiver Eligibility Criteria:
• adult (≥ 18 years) relative or a friend of a patient who agrees to participate in the study whom the patient identified as living with them or having in-person contact with him or her at least twice per week.
• ability to read and respond to questions in English or Spanish or to complete questionnaires with the assistance of an interpreter.

You may not qualify if:

• Patients undergoing HCT for benign hematologic conditions
• Patients undergoing outpatient HCT.
• Patients with psychiatric or cognitive conditions which the treating clinicians believes prohibits compliance with study procedures

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (4)

• El-Jawahri A, LeBlanc TW, Kavanaugh A, Webb J, Fausto J, Traeger L, Greer JA, Jackson V, Horick N, Rabideau DJ, Fenech A, Newcomb R, Ufere NN, Caruso E, Pepper J, DeFilipp Z, Chen YB, Lee SJ, Temel JS. Multisite Randomized Trial of Inpatient Palliative Care Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation. J Clin Oncol. 2025 Aug 20;43(24):2700-2711. doi: 10.1200/JCO-25-00378. Epub 2025 Jun 23.

  PMID: 40549982 DERIVED

• 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

• Yang D, Newcomb R, Kavanaugh AR, Khalil D, Greer JA, Chen YB, DeFilipp Z, Temel J, Lee SJ, LeBlanc TW, El-Jawahri A. Protocol for multi-site randomized trial of inpatient palliative care for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation. Contemp Clin Trials. 2024 Mar;138:107460. doi: 10.1016/j.cct.2024.107460. Epub 2024 Jan 26.

  PMID: 38280483 DERIVED

• Newcomb R, Amonoo HL, Nelson AM, Choe J, Holmbeck K, Nabily A, Lee SJ, LeBlanc TW, El-Jawahri A. Coping in patients with hematologic malignancies undergoing hematopoietic cell transplantation. Blood Adv. 2024 Mar 26;8(6):1369-1378. doi: 10.1182/bloodadvances.2023011081.

  PMID: 38181820 DERIVED

Results Point of Contact

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

ael-jawahri@mgb.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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 22, 2018
• Study Start: September 30, 2018
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2023
• Last Updated: December 7, 2023
• Results First Posted: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)