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Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01084694
Recruitment Status : Unknown
Verified June 2017 by Northside Hospital, Inc..
Recruitment status was:  Active, not recruiting
First Posted : March 10, 2010
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
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.

Condition or disease
Depression Anxiety Fatigue Distress

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Impact of Hematopoeitic Stem Cell Transplantation on Primary Caregiver Level of Burden and Distress
Actual Study Start Date : April 19, 2010
Actual Primary Completion Date : September 29, 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Primary Outcome Measures :
  1. Level of distress & Feelings of Burden [ Time Frame: pre-transplant to 1 year post-transplant ]
    Primary objective is to investigate the level of distress and feelings of burden in caregivers of hematopoietic stem cell transplant patients.

Secondary Outcome Measures :
  1. Impact of patient distress, fatigue & pain on the level of caregiver distress & burden [ Time Frame: pre-transplant to one year post-transplant ]
  2. Impact of caregiver distress and burden on overall patient survival and length of patient hospitalization [ Time Frame: Pre-transplant to 1 year post-transplant ]
  3. Common characteristics of caregivers [ Time Frame: pre-transplant to one year post-transplant ]
    To identify common characteristics of caregivers who report significantly more feelings of burden or distress

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Inclusion Criteria:


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01084694

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United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Northside Hospital, Inc.
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Principal Investigator: Dawn Speckhart, PhD Northside Hospital

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Responsible Party: Northside Hospital, Inc. Identifier: NCT01084694     History of Changes
Other Study ID Numbers: NSH 888
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: June 2017

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

Additional relevant MeSH terms:
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Signs and Symptoms