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Inpatient Palliative Care for Patients Undergoing Hematopoietic Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03641378
Recruitment Status : Active, not recruiting
First Posted : August 22, 2018
Last Update Posted : August 24, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
El-Jawahri, Areej,M.D., Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stem Cell Transplant Other: Palliative Care Intervention Other: Standard Transplant Care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Site Randomized Trial of Inpatient Palliative Care for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation
Actual Study Start Date : September 30, 2018
Actual Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Patient-reported quality of life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) [ Time Frame: 2 weeks ]
    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


Secondary Outcome Measures :
  1. Patients' quality of life (QOL) longitudinally: FACT-BMT [ Time Frame: up to 1 year ]
    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

  2. Patients' symptom burden [ Time Frame: up to 1 year ]
    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

  3. Patients' fatigue [ Time Frame: up to 1 years ]
    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

  4. Patients' psychological distress [ Time Frame: up to 1 years ]
    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)

  5. Patients' depression [ Time Frame: up to 1 years ]
    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

  6. Patients' post-traumatic stress symptoms (PTSD) [ Time Frame: up to 1 years ]
    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

  7. Caregiver QOL: CARGOQOL [ Time Frame: up to 1 year ]
    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.

  8. Caregiver psychological distress [ Time Frame: up to 1 year ]
    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)

  9. Caregiver depression [ Time Frame: up to 1 year ]
    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.


Other Outcome Measures:
  1. Patient coping [ Time Frame: up to 1 year ]
    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.

  2. Caregiver coping [ Time Frame: up to 1 year ]
    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.

  3. mediation analysis (symptom burden and coping) as mediators of improvement in patient-reported QOL [ Time Frame: 2 week ]
    mediation analysis (mediation analyses are common in these types of studies, there is no novel new outcome measure here, but rather examining mediation)

  4. Moderation analysis to examine whether patient or transplant related characteristics are moderators of the effect of the intervention on patient-reported QOL [ Time Frame: 2 week ]
    moderation analysis (moderation analyses are common in these types of studies. there is no new novel outcome measure here, bur rather examining moderation)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641378


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Areej El-Jawahri, MD Massachusetts General Hospital
More Information
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Responsible Party: El-Jawahri, Areej,M.D., Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03641378    
Other Study ID Numbers: 18-261
R01CA222014 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by El-Jawahri, Areej,M.D., Massachusetts General Hospital:
Cancer Care