Patients with hematological malignacies C81-C96
Conditions
Interventions
Group 1: music-based attention training during weeks 1-4 in addition to standard care (twice a week, with each session lasting approximately 35-50 min.)
Group 2: music-based attention training during
Sponsors
Universität Leipzig
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Women or men; age = 18 years - Patients with hematological malignancies who have received cellular therapy (CAR-T or autologous/allogeneic SZT) - Cellular therapy must have been completed at least 30 days prior to the expected date of randomization - *Cellular therapy must have been completed for a maximum of 180 days at the expected time of randomization - *Life expectancy > 6 months - Fatigue defined as = 28 on the emotional dimension or = 25 on the cognitive dimension using EORTC QLQ-FA12 according to Blickle et al. (2026) - Patients' willingness to attend 8 appointments for music-based attention training and additional appointments for neuropsychological testing at the center - ECOG = 2 (patient is treated on an outpatient basis) - Signed informed consent form for participation in the study Criteria to be re-evaluated are marked with an *.
Exclusion criteria
Exclusion criteria: - Severely impaired hearing without compensation - Active underlying disease requiring systemic therapy - Graft-versus-host disease requiring steroid treatment (therapy with corticosteroids at a dosage of = 7.5 mg prednisolone equivalent is permitted) - *Underlying comorbidities that, in the physician's opinion, prevent participation in the study Not an exclusion criterion for study participation, but only for the optional MRI examination: Presence of any contraindications for MRI examinations. Criteria to be re-evaluated are marked with an *.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue measured by EORTC QLQ-FA12; items assessing the dimensions of emotional and cognitive fatigue are combined into a sum score; The survey is conducted for screening purposes and then at 5-week intervals. | — |
Secondary
| Measure | Time frame |
|---|---|
| Most measurable outcomes are assessed using comprehensive standardized questionnaires that must be completed at the start of the study and then at five-week intervals. In total, each patient will complete the questionnaires five times. The following questionnaires will be used: - Symptom reduction (further aspects): Distress (NCCN Distress Thermometer), depression, anxiety, frustration (PHQ-9/GAD-7), demoralization (DS-II), - Promotion of resilience and quality of life: Quality of life (EORTC QLQ-C30), resilience (RS-11), sense of purpose and spirituality (FACIT-SP-12) In addition to measuring subjectively perceived fatigue using self-report questionnaires, task-related fatigue (fatigability) can be objectively assessed through neuropsychological tests. This is to be done using simple reaction tests: - Neuropsychological tests to objectify fatigue symptoms Before the first music training - Assessing musical competence using GOLD MSI Before and after each music training: - Assessing mood using a mini depression status test and various questions related to the training After the 4-week training period: - Assessment of group cohesion using the GCQ-S - Assessment of treatment expectations using the G-EEE Optinal/explorative research: - structural and functional cranial MRI (sMRI, fMRI) to potentially objectify fatigue symptoms underlying brain changes | — |
Countries
Germany
Contacts
Public ContactBeatrice Berneck
Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie
Outcome results
None listed