Trial Information

A Pilot Study to Examine Physiological and Clinical Markers of Chronic Stress in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

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 care to a spouse or loved one with cancer is stressful and can have
negative consequences for an individual's psychological and physical health. In cancer
caregivers, studies have documented negative outcomes including symptoms of fatigue,
impaired sleep quality, poor quality of life, anxiety and depression. These outcomes are of
particular concern when cancer patients receive intense treatment such as hematopoietic stem
cell transplantation (HSCT) where caregivers are embedded in a treatment trajectory that can
extend 4 - 12 months. In dementia caregivers, additional outcomes have been reported
including poor health habits and impaired immunity. In addition, longitudinal studies have
also reported caregivers have an increased risk of morbidity and mortality, particularly
from cardiovascular disease.

The stress response is initiated in the brain, which determines both the physiological and
behavioral responses to an event. The normal' physiologic response is complex and dynamic
process by which the body responds to daily events in an effort to maintain equilibrium. If
the stress becomes overwhelming for the individual, either due to the number or magnitude of
stressors, the burden or overload can lead to dysregulation of biologic mediators and
behavioral changes (poor sleep, eating or drinking too much, smoking, lack of physical
activity) that can exacerbate disease (e.g. cardiovascular disease). A recent study in
cancer caregivers demonstrated marked changes in neurohormonal and inflammatory processes in
the year following a loved one's cancer diagnosis which may place the caregiver at risk for
morbidity and mortality from disease. The relationships among the physiologic and
psychological responses as well as behavioral changes to stress have not been explored in
HSCT caregivers.

What is clear from the literature is that caregiving is stressful, and it appears to
increase one's risk for morbidity and mortality, particularly by increasing cardiovascular
risk. What is less clear is what behavioral, psychological, physiological and clinical
changes are associated with the process of caregiver for individuals undergoing allogeneic
HSCT, a particularly long and stressful experience. The purpose of this exploratory, pilot
study is threefold: to longitudinally examine physiological, behavioral and clinical factors
in HSCT caregivers during the acute transplant recovery period, to compare those factors in
HSCT caregivers to non-caregivers, and to explore the associations among physiological,
psychological, behavioral and clinical factors in HSCT caregivers.

Subjects will be accrued to this protocol if they are adult caregivers for a transplant
recipient participating in their first allogeneic HSCT protocol at the Clinical Center. An
equal sample of healthy volunteers that are non-caregivers will be recruited to serve as
control subjects. A sample of 40 subjects (20 caregiver and 20 non-caregiver volunteers)
will be recruited to capture the essence of the experience and adequately explore this
population.

Each caregiver participant will have data collected prior to the recipient's HSCT (day 0),
during the first week of outpatient visits following the recipient's initial discharge from
the inpatient setting, and finally 6 weeks post the transplant recipients' initial discharge
from the hospital. Questionnaires will capture the psychological and behavioral outcomes and
include: Caregiver Reaction Assessment (caregivers only), Health-Promoting Lifestyle Profile
II, Perceived Stress Scale, The UCLA Loneliness Scale (Version 3), General Self-Efficacy
Scale, and PROMIS Short Forms for Anxiety, Depression, Sleep disturbance and Fatigue.
Clinical variables (e.g. vital signs) and physiological variables (e.g. cortisol) will be
collected along with the questionnaires during the clinic visit and following history and
physical exam by a Licensed Independent Practitioner (LIP). A sample of non-caregivers will
be minimally matched for age, gender, and race/ethnicity, and complete all study procedures
except the questionnaires that are specific to the caregiver's experience (e.g. caregiver
burden). There will be no long term follow-up after the study participation period.
Exploratory, hypothesis generating analyses will be performed using parametric and
non-parametric techniques.