Allogeneic Hematopoietic Stem Cell Transplantation
Conditions
Keywords
stem cell transplantation, allogeneic, humor therapy, distress, supportive care
Brief summary
This research study evaluates the impact of a humor intervention on distress (primary outcome), hope, depressive symptoms, anxiety, and pain (secondary outcomes) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Detailed description
Patients undergoing allo-HSCT often experience substantial psychological distress during hospitalization and after discharge. Research in pediatric patients with cancer as well as geriatric patients suggests that psychosocial burden might be decreased by humor therapy. Studies addressing the impact of humor therapy in adult patients with cancer are lacking. This randomized controlled trial primarily aims at assessing the effect of therapeutic humor on global distress in patients during their hospital stay for allo-HSCT. In addition, the study investigates hope, depressive symptoms, anxiety, and pain as secondary outcomes. The outcomes are measured via questionnaires. Study results may be beneficial for patients who experience distress during hospitalization for allo-HSCT.
Interventions
BEHAVIORALHumor therapy
Clown visits
Sponsors
Deutsche José Carreras Leukämie-Stiftung
Staburo GmbH
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Admission for allogeneic transplantation at the University Medical Center Hamburg-Eppendorf
Exclusion criteria
* Insufficient German language skills
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distress | Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28) | Measured with the Distress Thermometer (DT): Brief screening instrument to assess the level of perceived distress in patients with cancer (11-point scale ranging from 0 = no distress to 10 = extreme distress) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hope | Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28) | Measured with the Herth Hope Index (HHI): Short self-report instrument for the measurement of hope in clinical oncological care (12 items, 4-point Likert scale ranging from 1 = strongly disagree to 4 = strongly agree) |
| Depressive symptoms | Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +14 and +28) | Measured with the Patient Health Questionnaire-9 (PHQ-9): Short self-report instrument to assess the severity of depressive symptoms (9 items, 4-point Likert scale ranging from 0 = not at all to 3 = nearly every day) |
| Anxiety symptoms | Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +14 and +28) | Measured with the Generalized Anxiety Disorder Scale-7 (GAD-7): Short self-report instrument to assess the severity of anxiety symptoms (7 items, 4-point Likert scale ranging from 0 = not at all to 3 = nearly every day) |
| Pain intensity measured with the Numerical Rating Scale (NRS) | Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28) | Measured with the Numerical Rating Scale (NRS): Brief screening instrument to assess pain intensity (11-point scale ranging from 0 = no pain to 10 = worst imaginable pain) |
Countries
Germany
Contacts
Primary ContactNicolaus M. Kröger, Prof. Dr.
Backup ContactAngela Scherwath, Dr.
Outcome results
None listed