This study will evaluate the long-term functional status, psychosocial adjustment and quality
of life of patients with different types of diseases and conditions who have had an
allogeneic (donor) stem cell transplant. Information from this study may help patients and
families know better what they may expect long-term after transplant and will help health
care workers improve services to aid in patients' recovery.
People 18 years of age or older who have had an allogeneic stem cell transplant three or more
years before the start of this study may be eligible to participate.
Participants complete a series of questionnaires once a year for three years. The
questionnaires take about 40 minutes to complete and include information on patient
demographics, patients' physical, social, and emotional functioning, spiritual well being,
pain, mental health, general health, fatigue, and other areas of health-related quality of
life. The questionnaires are completed at home or during normally scheduled follow-up visits
to the NIH.
Clinical research in allogeneic hematopoietic stem cell transplantation (HSCT) documents
improvements in disease free intervals, disease free survival, and the severity of treatment
related toxicities. Those who survive, however, continue to experience side-effects and
psychological difficulties for years following allogeneic HSCT. Long term complications occur
as delayed effects of the conditioning regimen and the transplant as well as side effects
from medications required to maintain the new donor-derived immune system. In addition to
various biological complications, long-term effects on the psychological, social, physical,
functional and symptoms experience (growth and limitations) have been documented.
Although some knowledge exists to help us understand the experience of various groups of
allogeneic HSCT patients, the face of allogeneic transplant has changed considerably over the
last five years and limits the application of existing reports. Patients with new types of
diseases e.g. solid tumor and those who are older (greater than 55 years) and with more
significant debilitation are undergoing allogeneic HSCT. It is important for patients and
families to know the effects they can expect following an allogeneic transplant. This lack of
clarity of the research limits our ability to focus future intervention studies to begin
making a difference for patients at high risk for poor health outcomes following allogeneic
Understanding of factors associated with variability in recovery following allogeneic HSCT
can increase the likelihood that patients will ultimately return to a normal, productive
life. Existing research regarding the recovery of adult survivors of allogeneic HSCT
indicates that many patients experience difficulties in a variety of Health Related Quality
of Life (HRQL) domains. A critical issue which has remained unexamined concerns the extent to
which domains improve, remain static, or perhaps even deteriorates with the passage of time
after allogeneic HSCT. Results will be discussed with respect to their implications for both
the encouragement of realistic expectations for recovery following allogeneic HSCT as well as
the development of interventions.
The long term goal of this study is to characterize longitudinally the functional health,
psychosocial adjustment, HRQL and symptom experience associated with long term survival after
allogeneic HSCT. This study has two specific aims:
1. To examine the functional status, psychosocial adjustment and HRQL of patients greater
than or equal to 3 years following allogeneic HSCT.
2. To examine the symptom experience of patients greater than or equal to 3 years following
Data will be analyzed using methods of longitudinal analysis, such as the generalized
estimating equations, mixed-effects models and growth mixture modeling to evaluate change
over time for each outcome variable.
- INCLUSION CRITERIA:
Patients surviving three years or more from the date of first allogeneic HSCT provided at
the Clinical Center, NIH.
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.
Life expectancy of at least 6 months.