Quality of Life in Patients Who Have Undergone Stem Cell Transplant
NCT ID: NCT00128960
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
173 participants
OBSERVATIONAL
2005-08-11
Brief Summary
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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.
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Detailed Description
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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 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 allogeneic HSCT.
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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Participants with different types of diseases and conditions who have undergone an allogeneic (donor) stem cell transplant.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
ALL
No
Sponsors
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National Institutes of Health Clinical Center (CC)
NIH
Responsible Party
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Principal Investigators
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Sandra A Mitchell, C.R.N.P.
Role: PRINCIPAL_INVESTIGATOR
National Institutes of Health Clinical Center (CC)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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References
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Bevans MF, Mitchell SA, Barrett JA, Bishop MR, Childs R, Fowler D, Krumlauf M, Prince P, Shelburne N, Wehrlen L, Yang L. Symptom distress predicts long-term health and well-being in allogeneic stem cell transplantation survivors. Biol Blood Marrow Transplant. 2014 Mar;20(3):387-95. doi: 10.1016/j.bbmt.2013.12.001. Epub 2013 Dec 17.
Bevans MF, Mitchell SA, Barrett AJ, Bishop M, Childs R, Fowler D, Krumlauf M, Prince P, Shelburne N, Wehrlen L. Function, adjustment, quality of life and symptoms (FAQS) in allogeneic hematopoietic stem cell transplantation (HSCT) survivors: a study protocol. Health Qual Life Outcomes. 2011 Apr 17;9:24. doi: 10.1186/1477-7525-9-24.
Prince P, Mitchell SA, Wehrlen L, Childs R, Savani B, Yang L, Bevans M. Spiritual Well-Being in Hispanic and Non-Hispanic Survivors of Allogeneic Hematopoietic Stem Cell Transplantation. J Psychosoc Oncol. 2015;33(6):635-54. doi: 10.1080/07347332.2015.1082167.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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050216
Identifier Type: -
Identifier Source: org_study_id
05-CC-0216
Identifier Type: -
Identifier Source: secondary_id
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