Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant

Completed

• Conditions: Anxiety; Distress; Depression; Fatigue

• Registration Number: NCT01084694
• Lead Sponsor: Northside Hospital, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Study Start: 2010-04-19
• Primary Completion: 2017-09-29
• Study Completion: 2018-03-30
• Results First Submitted: 2018-03-30
• Results First Submitted QC: 2019-11-13
• Results First Posted: 2019-12-03
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Overall Patient Survival	Pre-transplant to 1 year post-transplant	Number of patients who are alive at 1 year
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

Trial Locations

Locations (1)

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States