Trial Information

Patient Reported Outcomes in View of Symptom Experience of Late Effects and Self-management After Haematopoietic Stem Cell Transplantation - A Mixed Methods Study

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