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

Complication of Transplant Clinical Trial

— SHIELD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02207322
• Other study ID #: 14-241
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: August 2017

Study information

• Verified date: March 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complication of Transplant

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiver Quality of Life	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
Other	Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS)	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
Other	Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS)	compare caregiver anxiety at week-2 using hospital anxiety and depression scale (HADS)	week 2
Primary	Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at 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	FACT-BMT Score at 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
Secondary	FACT-BMT Score at 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
Secondary	Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 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
Secondary	Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months	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
Secondary	Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months	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
Secondary	Fatigue Scores (as Measured by FACT-Fatigue) at 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
Secondary	Fatigue Scores (as Measured by FACT-Fatigue) at 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
Secondary	Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at 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
Secondary	Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 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
Secondary	Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 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