Hematologic Neoplasms Clinical Trial
— PROVIVOOfficial title:
Patient Reported Outcomes in View of Symptom Experience of Late Effects and Self-management After Haematopoietic Stem Cell Transplantation - A Mixed Methods Study
Verified date | January 2013 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Observational |
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.
Status | Completed |
Enrollment | 375 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Having received allogeneic SCT for haematological disease - = 1 year of follow-up experience after treatment - Ability to understand and read German and having signed the written informed consent Exclusion Criteria: - Patients with psychiatric illness that in the opinion of physicians prevent them from participating - Visual and/or hearing impairment which hinders participation in an interview/fill-out a questionnaire - Being illiterate - Actual acute care hospitalization stay at interview date - Terminal illness |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel | Basel | |
Switzerland | University Hospital Zürich | Zürich |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland | University Hospital, Zürich, University of Basel |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom experience | Patient reported symptom experience using items of the PRO-CTCAE | single measuring point at = 1 year after HSCT | No |
Secondary | Perception of late effects | Brief Illness Perception Questionnaire | single measuring point at = 1 year after HSCT | No |
Secondary | Self-management behaviors | Patient reported self-management behaviors measured by single items | single measuring point at = 1 year after HSCT | No |
Secondary | Self-management in view of medical and health tasks, emotional and role tasks | Patient reported self-management behaviors using single items and the Hospital Anxiety and Depression Scale | single measuring point at = 1 year after HSCT | No |
Secondary | Objective late effects | Physician graded late effects using the CTCAE criteria | single measuring point at = 1 year after HSCT | No |
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