Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
NCT ID:
NCT01468857
Eligibility 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 (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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01468857
Study Brief:
Protocol Section:
NCT01468857