Symptom Experience and Self-management After Haematopoietic Stem Cell Transplantation (PROVIVO)

• Symptom experience [ Time Frame: single measuring point at ≥ 1 year after HSCT ] [ Designated as safety issue: No ]
  Patient reported symptom experience using items of the PRO-CTCAE
  
  

• Perception of late effects [ Time Frame: single measuring point at ≥ 1 year after HSCT ] [ Designated as safety issue: No ]
  Brief Illness Perception Questionnaire
  
  
• Self-management behaviors [ Time Frame: single measuring point at ≥ 1 year after HSCT ] [ Designated as safety issue: No ]
  Patient reported self-management behaviors measured by single items
  
  
• Self-management in view of medical and health tasks, emotional and role tasks [ Time Frame: single measuring point at ≥ 1 year after HSCT ] [ Designated as safety issue: No ]
  Patient reported self-management behaviors using single items and the Hospital Anxiety and Depression Scale
  
  
• Objective late effects [ Time Frame: single measuring point at ≥ 1 year after HSCT ] [ Designated as safety issue: No ]
  Physician graded late effects using the CTCAE criteria
  
  

Long-term survivors after allogeneic SCT are presumably at a life-long increased risk for developing various adverse side effects; also termed 'late effects'. Late effects may appear months or years after treatment has ended, can persist chronically and may be experienced as rather distressing and burdensome. Since most late effects are only experienced subjectively in the form of physical and mental symptoms and are seldom captured during objective clinician-based evaluations, using self-report instruments is important for the early detection, management and alleviation of these symptoms. The collection of self-report data in studies and clinical practice is strongly recommended by the National Cancer Institute (NCI): they developed a Patient-Reported Outcomes bank based on the well established Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Besides managing symptoms associated with late-effects, patients with SCT are also requested to manage their emotions associated with having a chronic illness, their new life roles in order to have a meaningful, fulfilling life, and their medical regimen, in view of taking medications, smoking cessation, regularly exercising and monitoring for signs of infection. However, evidence investigating the prevalence of problems related to these complex set of self-management tasks is scarce.

Aims:

• To translate the PRO-CTCAE items into German in a culturally-sensitive way and to develop the content of a self-report instrument measuring symptom experience after allogeneic SCT
• To validate the newly developed scale and assess its psychometric properties
• To examine self reported symptom experience and objective measured late effects in 300 adult survivors ≥ 1 year after SCT
• To describe self-management behaviours in 300 adult survivors ≥ 1 year after SCT
• To assess the relationship between symptom experience and objective burden of late effects, survivors' perception of late effects and self-management in view of managing emotions, managing new life roles and managing medical and health tasks in 300 adult survivors ≥ 1 year after allogeneic SCT