Clinical trial · Observational
Physical and Emotional Health of Caregivers for People Who Have Had Stem Cell Transplants
A Pilot Study to Examine Physiological and Clinical Markers of Chronic Stress in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Family Caregivers | — | UNRESOLVED | — |
| Stress | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To compare physiological factors and biomarkers of cardiovascular illness among HSCT caregivers during the acute transplant recovery period to non-caregivers.
- timeFrame
- 6 weeks
Secondary outcomes (2)
- measure
- 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.
- timeFrame
- 6 weeks
- measure
- To characterize caregivers with no change and those with a change (in physiological or clinical factors) by demographic and HSCT recipient clinical factors.
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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 (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) 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
References
Publications (3)
- BACKGROUNDHodges 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
- BACKGROUNDNorthouse 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
- BACKGROUNDBurton 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