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

NCT01468857 | Completed

• 2 other identifiers: 11026511-CC-0265
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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....

Conditions

Stress; Family Caregivers

Keywords

Clinical Stress Markers; Chronic Stress; Allogeneic Hematopoietic Stem Cell Transplant; HSCT Caregivers; Cancer Caregivers; Stress; Family Caregivers

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (2)

• 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.

  6 weeks

• To characterize caregivers with no change and those with a change (in physiological or clinical factors) by demographic and HSCT recipient clinical factors.

  6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 (Beta)
• 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)
• 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?

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Hodges LJ, Humphris GM, Macfarlane G. A meta-analytic investigation of the relationship between the psychological distress of cancer patients and their carers. Soc Sci Med. 2005 Jan;60(1):1-12. doi: 10.1016/j.socscimed.2004.04.018.

  PMID: 15482862 BACKGROUND

• Northouse LL, Katapodi MC, Song L, Zhang L, Mood DW. Interventions with family caregivers of cancer patients: meta-analysis of randomized trials. CA Cancer J Clin. 2010 Sep-Oct;60(5):317-39. doi: 10.3322/caac.20081. Epub 2010 Aug 13.

  PMID: 20709946 BACKGROUND

• Burton LC, Newsom JT, Schulz R, Hirsch CH, German PS. Preventive health behaviors among spousal caregivers. Prev Med. 1997 Mar-Apr;26(2):162-9. doi: 10.1006/pmed.1996.0129.

  PMID: 9085384 BACKGROUND

Study Officials

• Margaret F Bevans, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: November 10, 2011
• Study Start: September 26, 2011
• Study Completion: September 28, 2017
• Last Updated: December 9, 2019

Record last verified: 2017-09-28

Locations

US (1)