Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant

Depression Clinical Trial

Official title:

The Impact of Hematopoeitic Stem Cell Transplantation on Primary Caregiver Level of Burden and Distress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084694
• Other study ID #: NSH 888
• Status: Completed
• Start date: April 19, 2010
• Est. completion date: March 30, 2018

Study information

• Verified date: January 2020
• Source: Northside Hospital, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 30, 2018
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Distress
• Fatigue

Locations

Country	Name	City	State
United States	Northside Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Northside Hospital, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline, Day 30 & 1 year
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	Baseline, Day 30 & 1 year
Secondary	Overall Patient Survival	Number of patients who are alive at 1 year	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	Baseline
Secondary	Length of Patient Hospitalization		pretransplant to 1 year post-transplant