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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.
 
ClinicalTrials.gov Identifier: NCT01084694
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : December 3, 2019
Last Update Posted : January 7, 2020
Sponsor:
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
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Fatigue




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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

  2. Overall Patient Survival [ Time Frame: Pre-transplant to 1 year post-transplant ]
    Number of patients who are alive at 1 year

  3. 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

  4. Length of Patient Hospitalization [ Time Frame: pretransplant to 1 year post-transplant ]


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
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

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 ClinicalTrials.gov identifier (NCT number): NCT01084694


Locations
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United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Northside Hospital, Inc.
Investigators
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Principal Investigator: Dawn Speckhart, PhD Northside Hospital
  Study Documents (Full-Text)

Documents provided by Northside Hospital, Inc.:
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Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT01084694    
Other Study ID Numbers: NSH 888
First Posted: March 10, 2010    Key Record Dates
Results First Posted: December 3, 2019
Last Update Posted: January 7, 2020
Last Verified: January 2020
Keywords provided by Northside Hospital, Inc.:
HSCT
Caregiver
Caregiver Burden
Allogeneic Transplant
Autologous Transplant
Hematopoietic Stem Cell Transplantation
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms