Status:
COMPLETED
Physical and Emotional Health of Caregivers for People Who Have Had Stem Cell Transplants
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Stress
Family Caregivers
Eligibility:
All Genders
18+ years
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 hig...
Detailed Description
There are approximately 65.7 million unpaid caregivers in the United States with an estimated 8 percent providing care to someone with cancer. Although benefit-finding has been reported, providing car...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 26 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 28 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01468857
Start Date
September 26 2011
End Date
September 28 2017
Last Update
December 9 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892