N/A
N=160
Supportive Care Intervention In Patients Hospitalized For Hematopoietic Stem Cell Transplantation (Shield)
Complication of Transplant
Bottom Line
View on ClinicalTrials.gov: NCT02207322 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2 — 86.60; 94.33 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- transplant with early palliative care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2 |
86.60; 94.33 | — |
| SECONDARY FACT-BMT Score at 3 Months |
106.66; 112.00 | — |
| SECONDARY FACT-BMT Score at 6 Months |
109.39; 112.11 | — |
| SECONDARY Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS) |
8.49; 6.74 | — |
| SECONDARY Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS) |
5.19; 3.49 | — |
| SECONDARY Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS) |
4.66; 3.45 | — |
| SECONDARY Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS) |
6.33; 4.08 | — |
| SECONDARY Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS) |
4.84; 4.08 | — |
| SECONDARY Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS) |
4.74; 4.13 | — |
| SECONDARY Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2 |
9.52; 8.25 | — |
| SECONDARY Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months |
5.94; 3.82 | — |
| SECONDARY Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months |
5.58; 3.95 | — |
| SECONDARY Fatigue Scores (as Measured by FACT-Fatigue) at Week-2 |
23.71; 27.59 | — |
| SECONDARY Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months |
35.60; 37.60 | — |
| SECONDARY Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2 |
37.74; 31.49 | — |
| SECONDARY Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months |
25.79; 21.44 | — |
| SECONDARY Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months |
26.18; 22.15 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02207322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.