Protocol Details
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 NOT currently recruiting participants.
Summary
Number |
05-CC-0216 |
Sponsoring Institute |
National Institutes of Health Clinical Center (CC) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Keywords |
Allogeneic Hematopoietic Stem Cell Transplant;
Health Related Quality of Life;
Symptom Experience;
Fatigue;
Functional Status;
Natural History |
Recruitment Keyword(s) |
None |
Condition(s) |
Long Term Psychological Affects on HSCT |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
NIH Clinical Center |
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.
Eligibility
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.
Citations:
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.
Contacts:
Clinical Trials Number:
NCT00128960