Inpatient Palliative Care for Patients Undergoing Hematopoietic Stem Cell Transplantation

Multi-Site Randomized Trial of Inpatient Palliative Care for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Stem Cell Transplant
• Intervention / Treatment: Other: Palliative Care Intervention; Other: Standard Transplant Care

Detailed Description

The Participant has a type of blood cancer and will be undergoing stem cell transplantation. Frequently people undergoing stem cell transplantation experience physical and emotional symptoms during the course of their hospitalization for stem cell transplantation. These can be very distressing to both patient and the family members. The study doctors want to know if the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these distressing symptoms may improve the participant overall care.

This team of clinicians is called the palliative care team and they focus on ways to improve the participant pain and other symptom management (nausea, fatigue, shortness of breath, anxiety, etc.) and to assist the participant and the participant's family in coping with the emotional and social issues associated with your diagnosis. The team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing serious illness.

The main purpose of this study is to compare two types of care - standard transplant oncology care and standard transplant oncology care with early involvement of palliative care clinicians to see which is better for improving the experience of patients and families with blood cancers 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 the participant and the participant 's caregivers' quality of life, physical symptoms, and mood. Study questionnaires will be completed in the hospital or clinic with assistance provided as need.

• Study Type: Interventional
• Enrollment (Actual): 546
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Massachusetts General Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patient Inclusion Criteria

• 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.

Exclusion Criteria:

Patient Exclusion Criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inpatient Palliative Care Intervention; 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; team of clinicians that specialize in the lessening (palliation) of many distressing symptoms
Experimental: Transplant Care Alone; Patients and Caregivers will complete baseline self-report assessments at the time of obtaining informed consent.; Standard Transplant Care	Other: Standard Transplant Care; Standard care per hospital guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' Quality of Life (QOL) Longitudinally: FACT-BMT	Compare patients' QOL using Functional Assessment of Cancer Therapy- Bone Marrow Transplant (FACT-BMT) longitudinally between the study groups Score range 0-164, with higher score indicating better quality of life	up to 6 months
Patients' Symptom Burden	Compare patients' symptoms using the revised Edmonton Symptom Assessment Scale (ESAS) scores between the study groups score range 0-100 with higher score indicating worse symptom burden	up to 6 months
Patients' Fatigue	Compare patients' fatigue using Functional Assessment of Cancer Therapy- Fatigue (FACT-fatigue) scores between the study groups score range from 0-52 with higher scores indicating lower fatigue symptoms	up to 6 months
Patients' Psychological Distress	Compare patients' depression and anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS) between the study groups The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)	up to 6 months
Patients' Depression	Compare patients' depression using Patient-Health Questionnaire - 9 (PHQ-9) between the study groups the PHQ-9 score ranges from 0-27, with higher score indicative more depressive symptoms	up to 6 months
Patients' Post-traumatic Stress Symptoms (PTSD)	Compare patients' post-traumatic stress symptoms using the PTSD Checklist- Civilian version (PCL-C) between the study groups PCL-C score ranges from 17-85 with higher scores indicating worse PTSD symptoms	up to 6 months
Caregiver QOL: CARGOQOL	Compare caregivers' QOL using caregiver oncology QOL questionnaire (CARGOQOL) scores between the study groups the caregiver oncology QOL questionnaire ranges from 0-116 with higher scores indicating better caregiver QOL.	up to 6 months
Caregiver Psychological Distress	Compare caregivers' psychological distress using hospital anxiety and depression scale (HADS) between the study groups the HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)	up to 6 months
Caregiver Depression	Compare caregivers' depression symptoms using the Patient Health Questionnaire - 9 (PHQ-9) between the study groups the PHQ-9 score ranges from 0-27 with higher scores indicating worse depression symptoms.	up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Coping	Compare patient coping using the Brief Cope questionnaire between the study groups We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy.	up to 1 year
Caregiver Coping	compare caregiver coping (Brief Cope) between the study groups. We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy.	up to 1 year
Mediation Analysis (Symptom Burden and Coping) as Mediators of Improvement in Patient-reported QOL	mediation analysis (mediation analyses are common in these types of studies, there is no novel new outcome measure here, but rather examining mediation)	2 week
Moderation Analysis to Examine Whether Patient or Transplant Related Characteristics Are Moderators of the Effect of the Intervention on Patient-reported QOL	moderation analysis (moderation analyses are common in these types of studies. there is no new novel outcome measure here, bur rather examining moderation)	2 week

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2018
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cancer Care
• Other Study ID Numbers: 18-261; R01CA222014 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No