Eligibility, any sex, with Depression or Anxiety. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Brief Symptom Inventory and Burden InterviewPrimary· Baseline, Day 30 & 1 year
Brief Symptom Inventory (BSI) measures overall distress. Scores can range from 0-72 with the higher score representing a higher level of distress. Each question is 0-4 with 4 being higher levels of distress. Clinically significant level of distress is 25+. Burden Interview is scored on a continuum. No clinically range, but higher scores mean higher feelings of burden. Scores range from 0-88.
Time frame: BSI scores and Burden scores were compared in caregivers of HSCT patients at preBMT and post BMT (30 days and 1 year).
Baseline BSI
Group
Value
95% CI
Autologous Transplant Recipients
6.2
0 – 32
Allogeneic Transplant Recipients
6.1
0 – 32
Day 30 BSI
Group
Value
95% CI
Autologous Transplant Recipients
6
0 – 34
Allogeneic Transplant Recipients
5.9
0 – 32
1 year BSI
Group
Value
95% CI
Autologous Transplant Recipients
5.3
0 – 39
Allogeneic Transplant Recipients
5.2
0 – 39
Baseline Burden
Group
Value
95% CI
Autologous Transplant Recipients
13.4
0 – 39
Allogeneic Transplant Recipients
13.1
0 – 39
Day 30 Burden
Group
Value
95% CI
Autologous Transplant Recipients
18.1
0 – 36
Allogeneic Transplant Recipients
17.9
0 – 35
1 year Burden
Group
Value
95% CI
Autologous Transplant Recipients
18
0 – 37
Allogeneic Transplant Recipients
18
0 – 36
Patient Distress, Fatigue & Pain ScoresSecondary· Baseline, Day 30 & 1 year
BSI scale 0-72 with the higher score representing higher distress Brief Fatigue inventory 0-90 with the higher score representing higher fatigue Brief Pain inventory 0-120 with the higher score representing higher pain
Baseline BSI
Group
Value
95% CI
Autologous Transplant Recipients
9.1
0 – 30
Allogeneic Transplant Recipients
8.9
0 – 31
Baseline BFI
Group
Value
95% CI
Autologous Transplant Recipients
24
0 – 59
Allogeneic Transplant Recipients
24
0 – 59
Baseline BPI
Group
Value
95% CI
Autologous Transplant Recipients
15
0 – 66
Allogeneic Transplant Recipients
15
0 – 66
Day 30 BSI
Group
Value
95% CI
Autologous Transplant Recipients
9.2
0 – 31
Allogeneic Transplant Recipients
9.1
0 – 32
Day 30 BFI
Group
Value
95% CI
Autologous Transplant Recipients
27
0 – 66
Allogeneic Transplant Recipients
28
0 – 67
Day 30 BPI
Group
Value
95% CI
Autologous Transplant Recipients
19
0 – 71
Allogeneic Transplant Recipients
19
0 – 72
1 year BSI
Group
Value
95% CI
Autologous Transplant Recipients
7.8
0 – 33
Allogeneic Transplant Recipients
7.6
0 – 33
1 year BFI
Group
Value
95% CI
Autologous Transplant Recipients
21
0 – 63
Allogeneic Transplant Recipients
22
0 – 64
Overall Patient SurvivalSecondary· Pre-transplant to 1 year post-transplant
Number of patients who are alive at 1 year
Group
Value
95% CI
Autologous Transplant Recipients
42
Allogeneic Transplant Recipients
38
Common Characteristics of CaregiversSecondary· Baseline
12 demographic characteristics were collected. If common characteristics were found then it would have been analyzed for correlation with caregiver burden and distress
Group
Value
95% CI
Caregivers for Autologous Transplant Recipients
0
Caregivers for Allogeneic Transplant Recipients
0
Length of Patient HospitalizationSecondary· pretransplant to 1 year post-transplant
Group
Value
95% CI
Autologous Transplant Recipients
10.72
1 – 76
Allogeneic Transplant Recipients
29.34
2 – 119
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Northside Hospital, Inc.
Last refreshed: 7 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01084694.