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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Day 30 & 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Day 30 & 1 year |
| Overall Patient Survival |
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Inclusion Criteria:
Patient:
Caregiver:
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The study population will be an autologous patient and their caregiver and an allogeneic patient and their caregiver
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Speckhart, PhD | Northside Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
Patients and caregivers were enrolled as dyads. Data was collected from both patients and caregivers.
Patients will be selected from our Program and will be undergoing evaluation for stem cell transplant.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Undergoing Autologous Transplant | 50% of patients enrolled in this study will be undergoing autologous transplant with one primary caregiver. |
| FG001 | Patients Undergoing Allogeneic Transplant | 50% of patients enrolled in this study will be undergoing allogeneic transplant with one primary caregiver. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Autologous Transplant | 50 pairs of autologous patients and their caregivers were enrolled |
| BG001 | Allogeneic Transplant | 50 pairs of allogeneic patients and their caregivers were enrolled |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 2 autologous caregivers and 4 allogeneic caregivers did not complete their age on the demographics page. Total autologous included = 48. Total allogeneic included = 46 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 74 caregivers met criteria for analysis | Posted | Mean | Full Range | units on a scale | Baseline, Day 30 & 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Undergoing Autologous Transplant | Patients undergoing autologous transplant |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dawn Speckhart, PhD | Northside Hospital | 404-255-1930 | dawn.speckhart@northside.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2015 | May 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D005221 | Fatigue |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
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Number of patients who are alive at 1 year |
| Pre-transplant to 1 year post-transplant |
| 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 | Baseline |
| Length of Patient Hospitalization | pretransplant to 1 year post-transplant |
| eligibility not maintained |
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Region of enrollment for patients | Number | participants |
|
| Region of Enrollment | Region of enrollment for caregivers | Number | participants |
|
| Allogeneic Transplant Recipients |
patients receiving allogeneic transplants |
|
|
| 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 | This measure was assessed in patients. | Posted | Mean | Full Range | units on a scale | Baseline, Day 30 & 1 year |
|
|
|
| Secondary | Overall Patient Survival | Number of patients who are alive at 1 year | Posted | Count of Participants | Participants | Pre-transplant to 1 year post-transplant |
|
|
|
| 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 | Caregivers were analyzed | Posted | Number | common characteristics | Baseline |
|
|
|
| Secondary | Length of Patient Hospitalization | Posted | Mean | Full Range | days | pretransplant to 1 year post-transplant |
|
|
|
| 8 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Patients Undergoing Allogeneic Transplant | Patients undergoing allogeneic transplant | 12 | 50 | 0 | 50 | 0 | 50 |
| EG002 | Caregivers for Patients Undergoing Autologous Transplant | Caregivers for patients undergoing autologous transplant. Only emotional distress was monitored for the caregivers. | 0 | 50 | 0 | 50 | 0 | 50 |
| EG003 | Caregivers for Patients Undergoing Allogeneic Transplants | Caregivers for patients undergoing allogeneic transplant. Only emotional distress was monitored for the caregivers | 0 | 50 | 0 | 50 | 0 | 50 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013315 | Stress, Psychological |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Baseline BPI |
|
| Day 30 BSI |
|
| Day 30 BFI |
|
| Day 30 BPI |
|
| 1 year BSI |
|
| 1 year BFI |
|
| 1 year BPI |
|