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

October 15, 2024 updated by: El-Jawahri, Areej,M.D., Massachusetts General Hospital

Randomized Study of a Targeted Inpatient Supportive Care Intervention in Patients Hospitalized for Hematopoietic Stem Cell Transplantation (HSCT)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This research study is evaluating the impact of early involvement of supportive care team working with the transplant oncology team will have on the quality of life, symptoms, and mood of patients 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 participant's and their caregivers' quality of life, physical symptoms, and mood. Study questionnaires will be completed in the hospital or clinic with assistance provided as needed

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard transplant care

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
FACT-BMT Score at 3 Months
Time Frame: 3 months
adjusted patient-reported quality of life (QOL) at 3-month adjusting for baseline QOL scores Score range 0-164 with higher scores indicating better quality of life
3 months
FACT-BMT Score at 6 Months
Time Frame: 6 Months
compare quality of life between the two study arms at 6 months adjusting for baseline scores Score range 0-164 with higher scores indicating better quality of life
6 Months
Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)
Time Frame: week-2
compare depression symptoms using HADS at week-2 adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms
week-2
Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)
Time Frame: 3 month
compare depression symptoms using HADS at 3 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms
3 month
Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)
Time Frame: 6 months
Compare depression symptoms using HADS at 6 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms
6 months
Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)
Time Frame: week-2
compare anxiety symptoms using HADS at week-2 adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms
week-2
Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS)
Time Frame: 3 months
compare anxiety symptoms using HADS at 3 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms
3 months
Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS)
Time Frame: 6 months
compare anxiety symptoms using HADS at 6 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms
6 months
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2
Time Frame: week 2
compare PHQ-9 score at week-2 between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression
week 2
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months
Time Frame: 3-month
compare PHQ-9 score at 3-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression
3-month
Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months
Time Frame: 6-month
compare PHQ-9 score at 6-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression
6-month
Fatigue Scores (as Measured by FACT-Fatigue) at Week-2
Time Frame: week-2
examine change in fatigue scores at week-2 adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms
week-2
Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months
Time Frame: 3-months
compare change in fatigue scores at 3 months adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms
3-months
Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2
Time Frame: week-2
compare symptom burden as measured by Edmonton Symptom Assessment Scale at week-2 adjusting for baseline scores Symptoms burden range is from 0-90 with higher scores indicating higher symptom burden
week-2
Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months
Time Frame: 3-months
Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 3 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms
3-months
Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months
Time Frame: 6-months
Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 6 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms
6-months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caregiver Quality of Life
Time Frame: week-2
we will use the CareGiver Oncology QOL questionnaire (CarGOQOL) to compare caregiver QOL at week-2 between the study arms caregiver quality of life score ranges from 0-120 with higher scores indicating better caregiver quality of life
week-2
Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS)
Time Frame: week 2
compare caregiver depression at week-2 using hospital anxiety and depression scale (HADS) caregiver depression score ranges from 0-21 with higher score indicating higher depression symptoms
week 2
Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS)
Time Frame: week 2
compare caregiver anxiety at week-2 using hospital anxiety and depression scale (HADS)
week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-241

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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