Clinical trial NCT03641378: Inpatient Palliative Care for Patients Undergoing Hematopoietic Stem Cell Transplantation
Official title: Multi-Site Randomized Trial of Inpatient Palliative Care for Patients With Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stem Cell Transplant
Keywords: Cancer Care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2018-08-22
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Patient-reported Quality of Life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
timeFrame: 2 weeks
Secondary outcomes:
measure: Patients' Quality of Life (QOL) Longitudinally: FACT-BMT
timeFrame: up to 6 months
measure: Patients' Symptom Burden
timeFrame: up to 6 months
measure: Patients' Fatigue
timeFrame: up to 6 months
measure: Patients' Psychological Distress
timeFrame: up to 6 months
measure: Patients' Depression
timeFrame: up to 6 months
measure: Patients' Post-traumatic Stress Symptoms (PTSD)
timeFrame: up to 6 months
measure: Caregiver QOL: CARGOQOL
timeFrame: up to 6 months
measure: Caregiver Psychological Distress
timeFrame: up to 6 months
measure: Caregiver Depression
timeFrame: up to 6 months
Other outcomes:
measure: Patient Coping
timeFrame: up to 1 year
measure: Caregiver Coping
timeFrame: up to 1 year
measure: Mediation Analysis (Symptom Burden and Coping) as Mediators of Improvement in Patient-reported QOL
timeFrame: 2 week
measure: Moderation Analysis to Examine Whether Patient or Transplant Related Characteristics Are Moderators of the Effect of the Intervention on Patient-reported QOL
timeFrame: 2 week
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
References: