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Clinical Trial: Prospective Assessment of Functional Status, Psychosocial Adjustment, Health Related Quality of Life and the Symptom Experience in Patients Treated with Allogeneic Hematopoietic Stem Cell Transplantation
This study is currently recruiting patients.
Verified by National Institutes of Health Clinical Center (CC) August 3, 2005
Purpose
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 HSCT.
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 intervention.
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 allogeneic HSCT.
Data will be analyzed using methods of longitudinal analysis, such as the generalized estimating equations and the mixed-effects models to evaluate change over time for each outcome variable.
MedlinePlus consumer health information
Study Type: Observational
Study Design: Natural History
Further Study Details:
Expected Total Enrollment: 150
Study start: August 5, 2005
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 HSCT.
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 intervention.
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 allogeneic HSCT.
Data will be analyzed using methods of longitudinal analysis, such as the generalized estimating equations and the mixed-effects models to evaluate change over time for each outcome variable.
Eligibility
Genders Eligible for Study: Both
Criteria
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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00128960
Maryland
National Institutes of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland, 20892, United States; Recruiting
Patient Recruitment and Public Liaison Office 1-800-411-1222 prpl@mail.cc.nih.gov
TTY 1-866-411-1010
TTY 1-866-411-1010
More Information
Detailed Web Page
Publications
Goldman JM, Horowitz MM. The international bone marrow transplant registry. Int J Hematol. 2002 Aug;76 Suppl 1:393-7. Review.
Rodriguez TE, Stiff PJ. Current treatment results of allogeneic bone marrow transplantation for acute myeloid and lymphoid leukemia. Curr Hematol Rep. 2003 Jul;2(4):295-301. Review.
Thomas ED, Blume KG. Historical markers in the development of allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 1999;5(6):341-6. Review. No abstract available.
Study ID Numbers: 050216; 05-CC-0216
Last Updated: August 9, 2005
Record first received: August 9, 2005
ClinicalTrials.gov Identifier: NCT00128960
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 9, 2005
Record first received: August 9, 2005
ClinicalTrials.gov Identifier: NCT00128960
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23
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