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Completed

NCT Number: NCT02207322

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

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.

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Key information

Conditions

Complication of Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transplant with early palliative care

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

Other outcomes

  1. 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

  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

  3. 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)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: SHIELD

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Aug 4, 2014
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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