Anxiety, Depression, Distress, Fatigue
Conditions
Keywords
HSCT, Caregiver, Caregiver Burden, Allogeneic Transplant, Autologous Transplant, Hematopoietic Stem Cell Transplantation
Brief 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.
Interventions
None listed
Sponsors
Northside Hospital, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Symptom Inventory and Burden Interview | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Distress, Fatigue & Pain Scores | 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 |
| Overall Patient Survival | Pre-transplant to 1 year post-transplant | Number of patients who are alive at 1 year |
| Common Characteristics of Caregivers | Baseline | 12 demographic characteristics were collected. If common characteristics were found then it would have been analyzed for correlation with caregiver burden and distress |
| Length of Patient Hospitalization | pretransplant to 1 year post-transplant | — |
Countries
United States
Participant flow
Recruitment details
Patients will be selected from our Program and will be undergoing evaluation for stem cell transplant.
Pre-assignment details
Patients and caregivers were enrolled as dyads. Data was collected from both patients and caregivers.
Participants by arm
| Arm | Count |
|---|---|
| Autologous Transplant 50 pairs of autologous patients and their caregivers were enrolled | 50 |
| Allogeneic Transplant 50 pairs of allogeneic patients and their caregivers were enrolled | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 12 |
| Overall Study | eligibility not maintained | 2 | 7 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Autologous Transplant | Allogeneic Transplant | Total |
|---|---|---|---|
| Age, Categorical Caregivers <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Caregivers >=65 years | 16 Participants | 12 Participants | 28 Participants |
| Age, Categorical Caregivers Between 18 and 65 years | 32 Participants | 34 Participants | 66 Participants |
| Age, Categorical Patients <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Patients >=65 years | 15 Participants | 9 Participants | 24 Participants |
| Age, Categorical Patients Between 18 and 65 years | 35 Participants | 41 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 48 Participants | 47 Participants | 95 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Patients Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Patients Not Hispanic or Latino | 50 Participants | 49 Participants | 99 Participants |
| Ethnicity (NIH/OMB) Patients Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 13 Participants | 6 Participants | 19 Participants |
| Race (NIH/OMB) Caregivers More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Caregivers White | 34 Participants | 41 Participants | 75 Participants |
| Race (NIH/OMB) Patients American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Patients Black or African American | 12 Participants | 7 Participants | 19 Participants |
| Race (NIH/OMB) Patients More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Patients Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients White | 37 Participants | 42 Participants | 79 Participants |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Caregivers Female | 36 Participants | 36 Participants | 72 Participants |
| Sex: Female, Male Caregivers Male | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Patients Female | 37 Participants | 36 Participants | 73 Participants |
| Sex: Female, Male Patients Male | 13 Participants | 14 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 8 / 50 | 12 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
Primary
Brief Symptom Inventory and Burden Interview
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).
Time frame: Baseline, Day 30 & 1 year
Population: 74 caregivers met criteria for analysis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Autologous Transplant Recipients | Brief Symptom Inventory and Burden Interview | Baseline BSI | 6.2 units on a scale |
| Autologous Transplant Recipients | Brief Symptom Inventory and Burden Interview | Day 30 BSI | 6 units on a scale |
| Autologous Transplant Recipients | Brief Symptom Inventory and Burden Interview | 1 year BSI | 5.3 units on a scale |
| Autologous Transplant Recipients | Brief Symptom Inventory and Burden Interview | Baseline Burden | 13.4 units on a scale |
| Autologous Transplant Recipients | Brief Symptom Inventory and Burden Interview | Day 30 Burden | 18.1 units on a scale |
| Autologous Transplant Recipients | Brief Symptom Inventory and Burden Interview | 1 year Burden | 18 units on a scale |
| Allogeneic Transplant Recipients | Brief Symptom Inventory and Burden Interview | Day 30 Burden | 17.9 units on a scale |
| Allogeneic Transplant Recipients | Brief Symptom Inventory and Burden Interview | Baseline BSI | 6.1 units on a scale |
| Allogeneic Transplant Recipients | Brief Symptom Inventory and Burden Interview | Baseline Burden | 13.1 units on a scale |
| Allogeneic Transplant Recipients | Brief Symptom Inventory and Burden Interview | Day 30 BSI | 5.9 units on a scale |
| Allogeneic Transplant Recipients | Brief Symptom Inventory and Burden Interview | 1 year Burden | 18 units on a scale |
| Allogeneic Transplant Recipients | Brief Symptom Inventory and Burden Interview | 1 year BSI | 5.2 units on a scale |
Secondary
Common Characteristics of Caregivers
12 demographic characteristics were collected. If common characteristics were found then it would have been analyzed for correlation with caregiver burden and distress
Time frame: Baseline
Population: Caregivers were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autologous Transplant Recipients | Common Characteristics of Caregivers | 0 common characteristics |
| Allogeneic Transplant Recipients | Common Characteristics of Caregivers | 0 common characteristics |
Secondary
Length of Patient Hospitalization
Time frame: pretransplant to 1 year post-transplant
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Autologous Transplant Recipients | Length of Patient Hospitalization | 10.72 days |
| Allogeneic Transplant Recipients | Length of Patient Hospitalization | 29.34 days |
Secondary
Overall Patient Survival
Number of patients who are alive at 1 year
Time frame: Pre-transplant to 1 year post-transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Autologous Transplant Recipients | Overall Patient Survival | 42 Participants |
| Allogeneic Transplant Recipients | Overall Patient Survival | 38 Participants |
Secondary
Patient Distress, Fatigue & Pain Scores
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
Time frame: Baseline, Day 30 & 1 year
Population: This measure was assessed in patients.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Autologous Transplant Recipients | Patient Distress, Fatigue & Pain Scores | Baseline BFI | 24 units on a scale |
| Autologous Transplant Recipients | Patient Distress, Fatigue & Pain Scores | Day 30 BPI | 19 units on a scale |
| Autologous Transplant Recipients | Patient Distress, Fatigue & Pain Scores | Day 30 BSI | 9.2 units on a scale |
| Autologous Transplant Recipients | Patient Distress, Fatigue & Pain Scores | 1 year BSI | 7.8 units on a scale |
| Autologous Transplant Recipients | Patient Distress, Fatigue & Pain Scores | Baseline BPI | 15 units on a scale |
| Autologous Transplant Recipients | Patient Distress, Fatigue & Pain Scores | 1 year BFI | 21 units on a scale |
| Autologous Transplant Recipients | Patient Distress, Fatigue & Pain Scores | Day 30 BFI | 27 units on a scale |
| Autologous Transplant Recipients | Patient Distress, Fatigue & Pain Scores | 1 year BPI | 14 units on a scale |
| Autologous Transplant Recipients | Patient Distress, Fatigue & Pain Scores | Baseline BSI | 9.1 units on a scale |
| Allogeneic Transplant Recipients | Patient Distress, Fatigue & Pain Scores | 1 year BPI | 14 units on a scale |
| Allogeneic Transplant Recipients | Patient Distress, Fatigue & Pain Scores | Baseline BSI | 8.9 units on a scale |
| Allogeneic Transplant Recipients | Patient Distress, Fatigue & Pain Scores | Baseline BFI | 24 units on a scale |
| Allogeneic Transplant Recipients | Patient Distress, Fatigue & Pain Scores | Baseline BPI | 15 units on a scale |
| Allogeneic Transplant Recipients | Patient Distress, Fatigue & Pain Scores | Day 30 BSI | 9.1 units on a scale |
| Allogeneic Transplant Recipients | Patient Distress, Fatigue & Pain Scores | Day 30 BFI | 28 units on a scale |
| Allogeneic Transplant Recipients | Patient Distress, Fatigue & Pain Scores | Day 30 BPI | 19 units on a scale |
| Allogeneic Transplant Recipients | Patient Distress, Fatigue & Pain Scores | 1 year BSI | 7.6 units on a scale |
| Allogeneic Transplant Recipients | Patient Distress, Fatigue & Pain Scores | 1 year BFI | 22 units on a scale |