Rare Diseases

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Chronic Graft Versus Host Disease

Margaret F Bevans, Ph.D.

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....

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.

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

National Institutes of Health Clinical Center (CC)

Behaviors and Mental Disorders

Stress, Psychological

Behavioral Symptoms

Receives stress reduction intervention introduction with daily practice

Stress reduction intervention

Lena Jumin Lee (Park), Ph.D.

Background:

- People who have an allogeneic hematopoietic stem cell transplant (HSCT) need help as they recover. Being a caregiver can be stressful to the body and mind. Researchers want to find ways to reduce this stress.

Objective:

- To see how a stress reduction intervention affects the stress levels and health of an HSCT caregiver.

Eligibility:

- Adults age 18 and older who plan to be an active caregiver for a person having their first allogeneic HSCT at the NIH Clinical Center. An active caregiver is someone who will be caring for the person from just before admission for the HSCT until at least 6 weeks after.

Design:

* Participants will be put in either the intervention group or the control group.
* All participants will get the usual caregiver education given to all patients and caregivers having a stem cell transplant at the NIH Clinical Center.
* All participants will have 2 study visits. They will give blood samples. They will have health assessments and brief physical exams. They will fill out study questionnaires and have an exit interview.
* The intervention group will get an MP3 player. It will have an audio file with a stress reduction intervention on it. Participants will do this intervention daily. It takes 20 minutes. They will do gentle stretches and breathing exercises. They will get a diary to track their practice.
* The intervention group also will have follow-up phone calls 2 and 4 weeks after their first clinic visit.
* The person getting the HSCT will not be actively involved in the study.
* The study will last about 2 months....

Millions of Americans provide unpaid care for aging or ill family members and friends. Caregiving for an individual with cancer who is undergoing stem cell transplantation is particularly stressful. The stress of caregiving is associated with many disorders, including sleep disturbances, depression, and anxiety. Although there is good evidence that cancer caregivers experience high levels of stress and stress-related symptoms, few interventions studies have been explored to address this concern in this population.

Stress reduction techniques are important skills for individuals to cope with the stress of cancer caregiving. Mindfulness techniques such as yoga and meditation reduce levels of stress and stress-related symptoms in caregivers. However, many caregivers are reluctant to take time away from the patient to attend to their own health and well-being. Few studies have explored yoga-based stress reduction interventions that can be performed at home or at the patient s bedside.

Based upon our past research examining stress and stress-related symptoms in stem cell transplant caregivers, this study is designed to determine preliminary effectiveness of a yoga-based stress reduction intervention in reducing levels of stress in caregivers during allogeneic hematopoietic stem cell transplant (HSCT). In addition, this study will explorefactors associated with change in caregiver stress and symptoms such as demographics, clinical variables, cardiometabolic and inflammatory markers, and health behaviors.

This study will use a prospective randomized control group design to examine the effects of a six-week yoga-based stress reduction intervention on perceived stress in caregivers of allogeneic HSCT patients. Subjects will be accrued to this protocol if they are a caregiver of an individual undergoing allogeneic HSCT at the Clinical Center, NIH, are greater than or equal to 18 years old, able to read English, stand and sit unassisted, raise arms over head without pain, and able to comprehend the investigational nature of the study. A sample of at least 78 caregivers is needed to adequately evaluate the effectiveness of the intervention.

All caregivers will attend the usual care group education provided at the Clinical Center for transplant caregivers. Caregivers randomized to the intervention group will be scheduled for one session with study personnel to receive a 20 minute audio file of gentle chair yoga poses and guided breath awareness, as well as instructions for performing them, and they will be asked to practice daily. Data, in the form of web-based questionnaires, as well as a physical assessment, demographic interview and blood work will be collected from all study participants at baseline (at or near the time of HSCT) and again at the end of the six-week intervention. There will be no long-term follow-up after the intervention period. Questionnaires include: Caregiver Reaction Assessment, Health-Promoting Lifestyle Profile II, Pittsburgh Sleep Quality Index, Freiburg Mindfulness Scale, PROMIS measures of anxiety, applied cognition, depression, positive affect and well-being, Multidimensional Fatigue Symptom Inventory-Short Form and NIH Toolbox measures of loneliness, self-efficacy, and perceived stress. Subjects will participate in an exit interview at the end of the study and the interventionist will complete a log, based on subject diaries, that tracks subject practice, and discrepancy between planned and actual session date and time. Quantitative analysis techniques will be used in this study.

Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

A Randomized Controlled Trial to Determine the Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

To examine whether HSCT caregivers participating in a stress reduction intervention demonstrate improvement in certain individual factors (self-efficacy, burden, and mindfulness), psychosocial factors (stress, anxiety, depression, loneliness, positive affect and well-being), behaviors (health behaviors) and symptoms (sleep, fatigue, depression, and cognitive impairment) compared with HSCT caregivers in the control group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Physical and Emotional Health of Caregivers for People Who Have Had Stem Cell Transplants	NCT01468857	Stress Family Caregive...		18 Years -	National Institutes of Health Clinical Center (CC)
Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients	NCT02257853	Stress, Psychol... Caregivers	Stress reductio...	18 Years -	National Institutes of Health Clinical Center (CC)
Physical and Emotional Health of Caregivers for People Who Have Had Stem Cell Transplants	NCT01468857	Stress Family Caregive...		18 Years -	National Institutes of Health Clinical Center (CC)

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