Trial Outcomes & Findings for Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant (NCT NCT01084694)
NCT ID: NCT01084694
Last Updated: 2020-01-07
Results Overview
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).
Recruitment status
COMPLETED
Target enrollment
100 participants
Primary outcome timeframe
Baseline, Day 30 & 1 year
Results posted on
2020-01-07
Participant Flow
Patients will be selected from our Program and will be undergoing evaluation for stem cell transplant.
Patients and caregivers were enrolled as dyads. Data was collected from both patients and caregivers.
Participant milestones
| Measure |
Patients Undergoing Autologous Transplant
50% of patients enrolled in this study will be undergoing autologous transplant with one primary caregiver.
|
Patients Undergoing Allogeneic Transplant
50% of patients enrolled in this study will be undergoing allogeneic transplant with one primary caregiver.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
44
|
30
|
|
Overall Study
NOT COMPLETED
|
6
|
20
|
Reasons for withdrawal
| Measure |
Patients Undergoing Autologous Transplant
50% of patients enrolled in this study will be undergoing autologous transplant with one primary caregiver.
|
Patients Undergoing Allogeneic Transplant
50% of patients enrolled in this study will be undergoing allogeneic transplant with one primary caregiver.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Death
|
2
|
12
|
|
Overall Study
eligibility not maintained
|
2
|
7
|
Baseline Characteristics
2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
Baseline characteristics by cohort
| Measure |
Autologous Transplant
n=50 Participants
50 pairs of autologous patients and their caregivers were enrolled
|
Allogeneic Transplant
n=50 Participants
50 pairs of allogeneic patients and their caregivers were enrolled
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Patients · <=18 years
|
0 Participants
n=50 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
0 Participants
n=50 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
0 Participants
n=100 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
|
Age, Categorical
Patients · Between 18 and 65 years
|
35 Participants
n=50 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
41 Participants
n=50 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
76 Participants
n=100 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
|
Age, Categorical
Patients · >=65 years
|
15 Participants
n=50 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
9 Participants
n=50 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
24 Participants
n=100 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
|
Age, Categorical
Caregivers · <=18 years
|
0 Participants
n=48 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
0 Participants
n=46 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
0 Participants
n=94 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
|
Age, Categorical
Caregivers · Between 18 and 65 years
|
32 Participants
n=48 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
34 Participants
n=46 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
66 Participants
n=94 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
|
Age, Categorical
Caregivers · >=65 years
|
16 Participants
n=48 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
12 Participants
n=46 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
28 Participants
n=94 Participants • 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46
|
|
Sex: Female, Male
Patients · Female
|
37 Participants
n=50 Participants
|
36 Participants
n=50 Participants
|
73 Participants
n=100 Participants
|
|
Sex: Female, Male
Patients · Male
|
13 Participants
n=50 Participants
|
14 Participants
n=50 Participants
|
27 Participants
n=100 Participants
|
|
Sex: Female, Male
Caregivers · Female
|
36 Participants
n=50 Participants
|
36 Participants
n=50 Participants
|
72 Participants
n=100 Participants
|
|
Sex: Female, Male
Caregivers · Male
|
14 Participants
n=50 Participants
|
14 Participants
n=50 Participants
|
28 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Patients · Hispanic or Latino
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Patients · Not Hispanic or Latino
|
50 Participants
n=50 Participants
|
49 Participants
n=50 Participants
|
99 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Patients · Unknown or Not Reported
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
|
48 Participants
n=50 Participants
|
47 Participants
n=50 Participants
|
95 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
|
2 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
5 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Patients · American Indian or Alaska Native
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Patients · Asian
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Patients · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Patients · Black or African American
|
12 Participants
n=50 Participants
|
7 Participants
n=50 Participants
|
19 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Patients · White
|
37 Participants
n=50 Participants
|
42 Participants
n=50 Participants
|
79 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Patients · More than one race
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Patients · Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Caregivers · Asian
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
13 Participants
n=50 Participants
|
6 Participants
n=50 Participants
|
19 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Caregivers · White
|
34 Participants
n=50 Participants
|
41 Participants
n=50 Participants
|
75 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
2 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
4 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
100 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 30 & 1 yearPopulation: 74 caregivers met criteria for analysis
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).
Outcome measures
| Measure |
Autologous Transplant Recipients
n=44 Participants
patients receiving autologous transplant
|
Allogeneic Transplant Recipients
n=30 Participants
patients receiving allogeneic transplants
|
|---|---|---|
|
Brief Symptom Inventory and Burden Interview
Baseline BSI
|
6.2 units on a scale
Interval 0.0 to 32.0
|
6.1 units on a scale
Interval 0.0 to 32.0
|
|
Brief Symptom Inventory and Burden Interview
Day 30 BSI
|
6 units on a scale
Interval 0.0 to 34.0
|
5.9 units on a scale
Interval 0.0 to 32.0
|
|
Brief Symptom Inventory and Burden Interview
1 year BSI
|
5.3 units on a scale
Interval 0.0 to 39.0
|
5.2 units on a scale
Interval 0.0 to 39.0
|
|
Brief Symptom Inventory and Burden Interview
Baseline Burden
|
13.4 units on a scale
Interval 0.0 to 39.0
|
13.1 units on a scale
Interval 0.0 to 39.0
|
|
Brief Symptom Inventory and Burden Interview
Day 30 Burden
|
18.1 units on a scale
Interval 0.0 to 36.0
|
17.9 units on a scale
Interval 0.0 to 35.0
|
|
Brief Symptom Inventory and Burden Interview
1 year Burden
|
18 units on a scale
Interval 0.0 to 37.0
|
18 units on a scale
Interval 0.0 to 36.0
|
SECONDARY outcome
Timeframe: Baseline, Day 30 & 1 yearPopulation: This measure was assessed in patients.
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
Outcome measures
| Measure |
Autologous Transplant Recipients
n=44 Participants
patients receiving autologous transplant
|
Allogeneic Transplant Recipients
n=30 Participants
patients receiving allogeneic transplants
|
|---|---|---|
|
Patient Distress, Fatigue & Pain Scores
1 year BFI
|
21 units on a scale
Interval 0.0 to 63.0
|
22 units on a scale
Interval 0.0 to 64.0
|
|
Patient Distress, Fatigue & Pain Scores
1 year BPI
|
14 units on a scale
Interval 0.0 to 70.0
|
14 units on a scale
Interval 0.0 to 73.0
|
|
Patient Distress, Fatigue & Pain Scores
Baseline BSI
|
9.1 units on a scale
Interval 0.0 to 30.0
|
8.9 units on a scale
Interval 0.0 to 31.0
|
|
Patient Distress, Fatigue & Pain Scores
Baseline BFI
|
24 units on a scale
Interval 0.0 to 59.0
|
24 units on a scale
Interval 0.0 to 59.0
|
|
Patient Distress, Fatigue & Pain Scores
Baseline BPI
|
15 units on a scale
Interval 0.0 to 66.0
|
15 units on a scale
Interval 0.0 to 66.0
|
|
Patient Distress, Fatigue & Pain Scores
Day 30 BSI
|
9.2 units on a scale
Interval 0.0 to 31.0
|
9.1 units on a scale
Interval 0.0 to 32.0
|
|
Patient Distress, Fatigue & Pain Scores
Day 30 BFI
|
27 units on a scale
Interval 0.0 to 66.0
|
28 units on a scale
Interval 0.0 to 67.0
|
|
Patient Distress, Fatigue & Pain Scores
Day 30 BPI
|
19 units on a scale
Interval 0.0 to 71.0
|
19 units on a scale
Interval 0.0 to 72.0
|
|
Patient Distress, Fatigue & Pain Scores
1 year BSI
|
7.8 units on a scale
Interval 0.0 to 33.0
|
7.6 units on a scale
Interval 0.0 to 33.0
|
SECONDARY outcome
Timeframe: Pre-transplant to 1 year post-transplantNumber of patients who are alive at 1 year
Outcome measures
| Measure |
Autologous Transplant Recipients
n=50 Participants
patients receiving autologous transplant
|
Allogeneic Transplant Recipients
n=50 Participants
patients receiving allogeneic transplants
|
|---|---|---|
|
Overall Patient Survival
|
42 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Caregivers were analyzed
12 demographic characteristics were collected. If common characteristics were found then it would have been analyzed for correlation with caregiver burden and distress
Outcome measures
| Measure |
Autologous Transplant Recipients
n=50 Participants
patients receiving autologous transplant
|
Allogeneic Transplant Recipients
n=50 Participants
patients receiving allogeneic transplants
|
|---|---|---|
|
Common Characteristics of Caregivers
|
0 common characteristics
|
0 common characteristics
|
SECONDARY outcome
Timeframe: pretransplant to 1 year post-transplantOutcome measures
| Measure |
Autologous Transplant Recipients
n=44 Participants
patients receiving autologous transplant
|
Allogeneic Transplant Recipients
n=30 Participants
patients receiving allogeneic transplants
|
|---|---|---|
|
Length of Patient Hospitalization
|
10.72 days
Interval 1.0 to 76.0
|
29.34 days
Interval 2.0 to 119.0
|
Adverse Events
Caregivers for Patients Undergoing Allogeneic Transplants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Undergoing Autologous Transplant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Patients Undergoing Allogeneic Transplant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths
Caregivers for Patients Undergoing Autologous Transplant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place