Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-29 @ 11:55 AM
Study NCT ID:
NCT01275534
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2011-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symptom Experience and Self-management After Haematopoietic Stem Cell Transplantation
Sponsor:
University Hospital, Basel, Switzerland
Organization:
Study Overview
Official Title:
Patient Reported Outcomes in View of Symptom Experience of Late Effects and Self-management After Haematopoietic Stem Cell Transplantation - A Mixed Methods Study
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROVIVO
Brief Summary:
In the study PROVIVO, a patient reported outcome instrument consisting of items from the PRO-CTCAE item bank measuring symptom experience of long-term survivors after allogeneic hematopoietic stem cell transplantation (SCT) will be developed. The instrument development is based on cognitive patient interviews, a survey of hematology experts and a literature review. In a subsequent cross-sectional study phase, the instrument will be validated in a sample of 300 allogeneic stem cell recipients and by the use of additional self report instruments it will be possible to explore how subjective symptom experience, problems in self-management and presence of late effects are connected.
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: