Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02257853 |
| Other study ID # |
140201 |
| Secondary ID |
14-CC-0201 |
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
January 5, 2015 |
| Est. completion date |
February 7, 2019 |
Study information
| Verified date |
October 2, 2023 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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....
Description:
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.
