Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant

NCT01084694 | Completed Results

• 1 other identifier: NSH 888
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Fatigue; Distress

Keywords

HSCT; Caregiver; Caregiver Burden; Allogeneic Transplant; Autologous Transplant; Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Brief Symptom Inventory and Burden Interview

  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 Outcomes (4)

• Patient Distress, Fatigue & Pain Scores

  Baseline, Day 30 & 1 year

• Overall Patient Survival

  Pre-transplant to 1 year post-transplant

• Common Characteristics of Caregivers

  Baseline

• Length of Patient Hospitalization

  pretransplant to 1 year post-transplant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Northside Hospital, Inc.: lead

Study Sites (1)

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Fatigue; Caregiver Burden

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress, Psychological

Results Point of Contact

• Title: Dr. Dawn Speckhart, PhD
• Organization: Northside Hospital

dawn.speckhart@northside.com

404-255-1930

Study Officials

• Dawn Speckhart, PhD

  Northside Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 10, 2010
• Study Start: April 19, 2010
• Primary Completion: September 29, 2017
• Study Completion: March 30, 2018
• Last Updated: January 7, 2020
• Results First Posted: December 3, 2019

Record last verified: 2020-01

Locations

US (1)