N/A
N=100
Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant
Depression · Anxiety · Fatigue · Distress
Bottom Line
View on ClinicalTrials.gov: NCT01084694 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Brief Symptom Inventory and Burden Interview — 6.2; 6.1; 6; 5.9 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Northside Hospital, Inc.
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Symptom Inventory and Burden Interview |
6.2; 6.1; 6; 5.9; 5.3; 5.2 | — |
| SECONDARY Patient Distress, Fatigue & Pain Scores |
9.1; 8.9; 24; 24; 15; 15 | — |
| SECONDARY Overall Patient Survival |
42; 38 | — |
| SECONDARY Common Characteristics of Caregivers |
0; 0 | — |
| SECONDARY Length of Patient Hospitalization |
10.72; 29.34 | — |
Summary
The purpose of this study is to examine the impact that serving as a caregiver for a patient undergoing hematopoietic stem cell transplant has on the caregiver. This will include looking at the caregiver's level of burden, depression, anxiety, somatic symptoms, fatigue and overall distress. It will also look at whether caregiver burden leads to an increase in hospitalization and overall outcome.
Eligibility Criteria
Inclusion Criteria
Patient:
- Any patient undergoing autologous or allogeneic HSCT at The Blood and Marrow Transplant Program at Northside Hospital
- Patients must have a single primary caregiver
- Patients must be willing to comply with all assessments as outlined in the protocol
- Patients must be willing to sign informed consent
Caregiver:
- Must be the primary caregiver for an autologous or allogenic HSCT patient at the Blood and Marrow Transplant Program at Northside Hospital
- Caregiver must be willing to comply will all assessments as outlined in the protocol
- Caregiver must be willing to sign consent
Data sourced from ClinicalTrials.gov (NCT01084694). 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.