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Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Northside Hospital, Inc.
ClinicalTrials.gov Identifier:
NCT01084694
First received: March 9, 2010
Last updated: March 16, 2017
Last verified: March 2017
  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: Observational Model: Other
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:


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 ]
    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 ]
  • Impact of caregiver distress and burden on overall patient survival and length of patient hospitalization [ Time Frame: Pre-transplant to 1 year post-transplant ]
  • 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


Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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 16, 2017

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

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on April 24, 2017