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Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant

This study is currently recruiting participants.
Verified March 2013 by Northside Hospital, Inc.
Sponsor:
Information provided by (Responsible Party):
Northside Hospital, Inc.
ClinicalTrials.gov Identifier:
NCT01084694
First received: March 9, 2010
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition
Depression
Anxiety
Fatigue
Distress

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Impact of Hematopoeitic Stem Cell Transplantation on Primary Caregiver Level of Burden and Distress

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northside Hospital, Inc.:

Primary Outcome Measures:
  • Level of distress & Feelings of Burden [ Time Frame: pre-transplant to 1 year post-transplant ] [ Designated as safety issue: No ]
    Primary objective is to investigate the level of distress and feelings of burden in caregivers of hematopoietic stem cell transplant patients.


Secondary Outcome Measures:
  • Impact of patient distress, fatigue & pain on the level of caregiver distress & burden [ Time Frame: pre-transplant to one year post-transplant ] [ Designated as safety issue: No ]
  • Impact of caregiver distress and burden on overall patient survival and length of patient hospitalization [ Time Frame: Pre-transplant to 1 year post-transplant ] [ Designated as safety issue: No ]
  • Common characteristics of caregivers [ Time Frame: pre-transplant to one year post-transplant ] [ Designated as safety issue: No ]
    To identify common characteristics of caregivers who report significantly more feelings of burden or distress


Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084694

Contacts
Contact: Dawn Speckhart, PhD 404-255-1930 dawn.speckhart@northside.com
Contact: Stacey Brown, BA 404-851-8238 stacey.brown@northside.com

Locations
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Dawn Speckhart, PhD     404-255-1930     dawn.speckhart@northside.com    
Contact: Stacey Brown, BA     404-851-8238     stacey.brown@northside.com    
Principal Investigator: Dawn Speckhart, PhD            
Sub-Investigator: Aurelia Summerlin, NP            
Sub-Investigator: H. Kent Holland, MD            
Sponsors and Collaborators
Northside Hospital, Inc.
Investigators
Principal Investigator: Dawn Speckhart, PhD Northside Hospital
  More Information

No publications provided

Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT01084694     History of Changes
Other Study ID Numbers: NSH 888
Study First Received: March 9, 2010
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northside Hospital, Inc.:
HSCT
Caregiver
Caregiver Burden
 Allogeneic Transplant
Autologous Transplant
Hematopoietic Stem Cell Transplantation

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Fatigue
 Mental Disorders
Behavioral Symptoms
Mood Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013