Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant

January 6, 2020 updated by: Northside Hospital, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be an autologous patient and their caregiver and an allogeneic patient and their caregiver

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Symptom Inventory and Burden Interview
Time Frame: 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).
Baseline, Day 30 & 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Distress, Fatigue & Pain Scores
Time Frame: 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
Baseline, Day 30 & 1 year
Overall Patient Survival
Time Frame: Pre-transplant to 1 year post-transplant
Number of patients who are alive at 1 year
Pre-transplant to 1 year post-transplant
Common Characteristics of Caregivers
Time Frame: Baseline
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
Time Frame: pretransplant to 1 year post-transplant
pretransplant to 1 year post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northside Hospital, Inc.

Investigators

  • Principal Investigator: Dawn Speckhart, PhD, Northside Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2010

Primary Completion (Actual)

September 29, 2017

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSH 888

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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