Physical and Emotional Health of Caregivers for People Who Have Had Stem Cell Transplants
|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: NCT01468857|
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : May 23, 2018
- 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.
- To study the physical and emotional health of caregivers for a family member or friend who has had a stem cell transplant.
- 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.
- 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 or disease|
|Stress Family Caregivers|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||A Pilot Study to Examine Physiological and Clinical Markers of Chronic Stress in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients|
|Study Start Date :||September 26, 2011|
|Study Completion Date :||September 28, 2017|
- To compare physiological factors and biomarkers of cardiovascular illness among HSCT caregivers during the acute transplant recovery period to non-caregivers. [ Time Frame: 6 weeks ]
- 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. [ Time Frame: 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. [ Time Frame: 6 weeks ]
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): NCT01468857
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Margaret F Bevans, Ph.D.||National Institutes of Health Clinical Center (CC)|