Hematologic Neoplasms Clinical Trial
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
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.
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
;
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03483194 -
Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care (REVEH)
|
Phase 2/Phase 3 | |
Recruiting |
NCT03735992 -
Mind-body Medicine for Patients With Malignant Hematological Diseases
|
N/A | |
Recruiting |
NCT04959175 -
Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies
|
Phase 1/Phase 2 | |
Withdrawn |
NCT04275154 -
Immunological Parameters, Neurocognitive Changes, Activity, & Driving Fitness in Patients Undergoing CAR-T Cell Therapy
|
||
Completed |
NCT00997386 -
Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States
|
Phase 2 | |
Terminated |
NCT00957580 -
Trial of Pimasertib in Hematological Malignancies
|
Phase 2 | |
Completed |
NCT00389428 -
Multicenter Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Cancer.
|
Phase 1 | |
Completed |
NCT02193880 -
Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)
|
N/A | |
Recruiting |
NCT00071045 -
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
|
||
Not yet recruiting |
NCT05054231 -
Immunological Profile for Patients Treated With CAR-T Cells
|
N/A | |
Completed |
NCT02650791 -
Platelet Transfusion Requirements in Hematopoietic Transplantation Pilot Study
|
Phase 3 | |
Completed |
NCT01362179 -
National Marrow Donor Program Long-Term Donor Follow-Up
|
||
Terminated |
NCT02900248 -
CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice
|
||
Terminated |
NCT03648372 -
A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System
|
Phase 1/Phase 2 | |
Recruiting |
NCT03320915 -
Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing HSCT
|
Phase 2 | |
Terminated |
NCT02895529 -
A Study Comparing the Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Participants With Hematological Malignancy
|
Phase 4 | |
Active, not recruiting |
NCT03680092 -
Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation
|
Phase 2 | |
Recruiting |
NCT03083327 -
Prophylactic Early PN in HPT/BMT
|
N/A | |
Recruiting |
NCT03743480 -
Early Palliative Care and Hematological Cancer Patients
|
N/A | |
Completed |
NCT02635984 -
Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens
|
Phase 3 |