hematologic disorders that meet the criteria for allogeneic stem cell transplantation C81-C96 D46 D56 D57 D60-D64 D80 D81 D82 D83 D84
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients with a confirmed indication for allogeneic HSCT will be recruited. Inclusion will occur after comprehensive oral and written information about the study and the option to withdraw at any time, and following written informed consent.
Exclusion criteria
Exclusion criteria: Patients who do not have a confirmed indication for allogeneic HSCT will not be included in the study. In addition, patients who do have a confirmed indication for allogeneic HSCT but but for whom, due to severe somatic or psychiatric limitations, the psychological and medical teams have jointly determined that performing an allogeneic HSCT is not justifiable (e.g., paranoid schizophrenia with noncompliance regarding medication).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This research project aims to conduct an exploratory study of the psychological distress experienced by patients over the course of an allogeneic stem cell transplant. The primary endpoint is the longitudinal assessment of changes in psychological well-being related to allogeneic stem cell transplantation and the engraftment of donor cells over the course of one year. To this end, psychological parameters such as sleep quality, pain levels, depression, anxiety symptoms, and fatigue will be repeatedly assessed at specified time points (see details under “Arm 1”) and analyzed descriptively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome includes an exploratory examination of changes in individual dimensions of psychological distress over the course of treatment. These include, in particular, changes in depressive and anxiety symptoms between the baseline assessment prior to allogeneic stem cell transplantation (pre-allo interview) and the assessments following transplantation, as well as at the time of discharge from the hospital and during follow-up in the outpatient setting. In addition, potential associations between psychological distress parameters and transplant-related clinical outcome parameters—particularly donor cell engraftment—will be explored. | — |
Countries
Germany
Contacts
Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV)