A RCT to determine the effectiveness of a stress reduction intervention in caregivers of allogeneic hematopoietic stem cell transplant (HSCT) recipients.

Clinical Center

Investigators

Abstract

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 patients bedside. 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 > 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, fatigue, positive affect and well-being, 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. The study was approved by the IRB on September 24, 2014, recruitment began and the 1st subject was enrolled in January 2015. As of September 2015, 13 subjects have been enrolled, with n=8 completing all study procedures and two subjects were removed from study participation.