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Physical and Emotional Health of Caregivers for People Who Have Had Stem Cell Transplants

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01468857
First received: October 6, 2011
Last updated: May 23, 2013
Last verified: August 2012
History of Changes
  Purpose

Background:

- Stem cell transplants are a complex treatment that can have serious side effects. Having a caregiver to help with the recovery is critical. Serving in this role, however, can cause high stress levels and negative health effects. Researchers want to better understand the health effects of caring for a family member or friend after a stem cell transplant. Understanding these effects can help develop programs that support caregivers coping with the demands of post-transplant care.

Objectives:

- To study the physical and emotional health of caregivers for a family member or friend who has had a stem cell transplant.

Eligibility:

  • Individuals at least 18 years of age who are planning to be a caregiver for a person having a stem cell transplant.
  • Healthy non-caregiver volunteers for comparison studies.

Design:

  • A caregiver will be caring for a transplant recipient just before transplant admission and up through 6 weeks after hospital discharge. The caregiver will usually live with or spend at least 6 hours each day with the recipient.
  • All participants will have three study visits. The first visit will happen before the transplant. The second and third visits will happen at the recipient's discharge, and 6 weeks after discharge. The following tests will be done at each visit:
  • A health assessment with a physical exam and review of life events and current health problems
  • Blood, hair, and saliva samples
  • Questionnaires about stress levels, personal health, and the caregiving process.
  • Caregiver participants may have an optional fourth study visit within 72 hours after an ICU admission. This visit will include the same tests as the other visits.

Condition
Stress
Family Caregivers

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Pilot Study to Examine Physiological and Clinical Markers of Chronic Stress in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To compare physiological factors and biomarkers of cardiovascular illness among HSCT caregivers during the acute transplant recovery period to non-caregivers.

Secondary Outcome Measures:
  • To examine associations among physiological variables (salivary cortisol, norepinephrine, epinephrine, hs-CRP, TNF, and hs-IL6) and psychological health and healthy behaviors in HSCT caregivers.
  • To characterize caregivers with no change and those with a change (in physiological or clinical factors) by demographic and HSCT recipient clinical factors.

Enrollment: 40
Study Start Date: September 2011
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Caregiver Subjects

  • Age greater than or equal to 18 years old
  • Ability to comprehend the investigational nature of the study
  • Able to read and speak English or Spanish
  • Agrees to participate in the study
  • Intends to serve as an active caregiver for a patient undergoing their 1st allogeneic HSCT at the NIH Clinical Center

Non-Caregiver Subjects

  • Age greater than or equal to 18 years old
  • Ability to comprehend the investigational nature of the study and provide informed consent
  • Able to read and speak English or Spanish
  • Agrees to participate in the study
  • Match caregiver subject based on age, gender, and race/ethnicity.

If more than one caregiver is planned for the transplant recipient during the transplant phase, all caregivers will be invited to participate in the study. An active caregiver is defined as someone who lives with (at least 6 hours/day) the HSCT recipient during the study period (pre-HSCHT through 6 weeks post-discharge).

EXCLUSION CRITERIA: (all subjects)

  • Age less than or equal to 18 years old
  • Pregnant or lactating women
  • Inability to comprehend investigational nature of study
  • Inability to provide informed consent
  • Unable to read and speak English or Spanish
  • Does not agree to participate in study or follow study design
  • Glucocorticosteroid treatment in the last 2 months
  • Diagnosis of Cushing, Addison or Parkinson's disease
  • Prior heart transplant, have a pacemaker, diagnosis of orthostatic hypotension or autonomic dysfunction
  • Smokers unwilling to cease smoking for at least 12 hours before specimen collection
  • Unwilling to cease alcohol consumption for at least 24 hours before specimen collection
  • Serving as a paid caregiver for any individual
  • Serving as the HSCT donor (undergoing Stem Cell Mobilization)

EXCLUSION CRITERIA NON-CAREGIVER SUBJECTS:

Experienced a stressful life event in the preceding 3 months before enrollment (as determined by the following pre-screening questions:

In the last 3 months have you experienced?

  • A serious illness, yourself or with someone close to you?
  • Death of someone close?
  • Faced imprisonment for yourself or someone close or had legal difficulties?
  • Been unemployed or had a change in your work?
  • Moved from your home or remodeled your home?
  • Been involved in a natural disaster?
  • A change in your marital status?
  • A pregnancy, birth, miscarriage, or stillbirth?

Currently receiving mental health services or taking psychiatric medications

Currently or in the last 3 months served as a caregiver

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468857

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
Principal Investigator: Margaret F Bevans, Ph.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT01468857     History of Changes
Other Study ID Numbers: 110265, 11-CC-0265
Study First Received: October 6, 2011
Last Updated: May 23, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Clinical Stress Markers
Chronic Stress
Allogeneic Hematopoietic Stem Cell Transplant
HSCT Caregivers
 Cancer Caregivers
Stress
Family Caregivers

ClinicalTrials.gov processed this record on June 18, 2013