Clinical trial · Observational
Symptom Experience and Self-management After Haematopoietic Stem Cell Transplantation
Patient Reported Outcomes in View of Symptom Experience of Late Effects and Self-management After Haematopoietic Stem Cell Transplantation - A Mixed Methods Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Symptom experience
- timeFrame
- single measuring point at ≥ 1 year after HSCT
- description
- Patient reported symptom experience using items of the PRO-CTCAE
Secondary outcomes (4)
- measure
- Perception of late effects
- timeFrame
- single measuring point at ≥ 1 year after HSCT
- description
- Brief Illness Perception Questionnaire
- measure
- Self-management behaviors
- timeFrame
- single measuring point at ≥ 1 year after HSCT
- description
- Patient reported self-management behaviors measured by single items
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKirsch M, Mitchell SA, Dobbels F, Stussi G, Basch E, Halter JP, De Geest S. Linguistic and content validation of a German-language PRO-CTCAE-based patient-reported outcomes instrument to evaluate the late effect symptom experience after allogeneic hematopoietic stem cell transplantation. Eur J Oncol Nurs. 2015 Feb;19(1):66-74. doi: 10.1016/j.ejon.2014.07.007. Epub 2014 Sep 1. PMID 25190633