title: Function, adjustment, quality of life and symptoms (FAQS) in allogeneic hematopoietic stem cell transplantation (HSCT) survivors: a study protocol.
abstract: BACKGROUND
  The population of survivors following allogeneic HSCT continues to increase, and yet their experiences of recovery and long-term survivorship have not been fully characterized. This paper presents a study protocol examining over time the functional status, psychosocial adjustment, health-related quality of life, and symptom experience of survivors who have undergone allogeneic transplantation. The aims of the study are to: 1) explore the patterns of change in these health outcomes during the survivorship phase; 2) characterize subgroups of survivors experiencing adverse outcomes; and 3) examine relationships among outcomes and demographic and clinical factors (such as age, graft-versus-host disease (GVHD), and disease relapse).
  
  
  METHODS
  In this longitudinal observational study, adults who survive a minimum of 3 years from date of allogeneic transplantation complete a series of questionnaires annually. Demographic and clinical data are collected along with a series of patient-reported outcome measures, specifically: 1) Medical Outcomes Study SF- 36; 2) Functional Assessment of Chronic Illness Therapy (FACIT) - General, 3) FACIT-Fatigue; 4) FACIT- Spiritual; 5) Psychosocial Adjustment to Illness Scale; 6) Rotterdam Symptom Checklist-Revised; and 7) Pittsburgh Sleep Quality Index.
  
  
  CONCLUSIONS
  This study will provide multidimensional patient-reported outcomes data to expand the understanding of the survivorship experience across the trajectory of allogeneic transplantation recovery. There are a number of inherent challenges in recruiting and retaining a diverse and representative sample of long-term transplant survivors. Study results will contribute to an understanding of outcomes experienced by transplant survivors, including those with chronic GVHD, malignant disease relapse, and other late effects following allogeneic transplantation.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00128960.
authors.affiliation: National Institutes of Health Clinical Center, Bethesda, MD, USA. mbevans@cc.nih.gov
authors.forename: Margaret F
authors.initials: MF
authors.lastname: Bevans
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Mitchell
authors.forename: A John
authors.initials: AJ
authors.lastname: Barrett
authors.forename: Michael
authors.initials: M
authors.lastname: Bishop
authors.forename: Richard
authors.initials: R
authors.lastname: Childs
authors.forename: Daniel
authors.initials: D
authors.lastname: Fowler
authors.forename: Michael
authors.initials: M
authors.lastname: Krumlauf
authors.forename: Patricia
authors.initials: P
authors.lastname: Prince
authors.forename: Nonniekaye
authors.initials: N
authors.lastname: Shelburne
authors.forename: Leslie
authors.initials: L
authors.lastname: Wehrlen
mesh_terms: D000223:Adaptation, Psychological; D000328:Adult; D006086:Graft vs Host Disease / Q000523:psychology; D006304:Health Status; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000523:psychology*; D006801:Humans; D011446:Prospective Studies; D011788:Quality of Life; D018434:Sickness Impact Profile; D012917:Social Adjustment; D011795:Surveys and Questionnaires; D017741:Survivors / Q000523:psychology; D014184:Transplantation, Homologous; D016896:Treatment Outcome