Skip to main content
OpenTrials
Completed

NCT Number: NCT01084694

Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Caregiver Burden Distress Fatigue Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress, Psychological

Sex eligibility

All sexes

Study type

Observational

Primary location

Northside Hospital

Atlanta, Georgia, 30342, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Northside Hospital, Inc.

Other

Registry information

Official study title

The Impact of Hematopoeitic Stem Cell Transplantation on Primary Caregiver Level of Burden and Distress

Important dates

Study start
2010
Primary completion
2017
Study completion
2018
First posted
Mar 10, 2010
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.