Clinical trial NCT03593161: Humor Therapy and Distress After Allogeneic Stem Cell Transplantation
Official title: The Effect of Humor Therapy on Perceived Distress After Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
Keywords: stem cell transplantation
allogeneic
humor therapy
distress
supportive care
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Deutsche José Carreras Leukämie-Stiftung
name: Staburo GmbH
First posted: 2018-07-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Admission for allogeneic transplantation at the University Medical Center Hamburg-Eppendorf

Exclusion Criteria:

* Insufficient German language skills

Primary outcomes:
measure: Distress
timeFrame: Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28)
Secondary outcomes:
measure: Hope
timeFrame: Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28)
measure: Depressive symptoms
timeFrame: Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +14 and +28)
measure: Anxiety symptoms
timeFrame: Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +14 and +28)
measure: Pain intensity measured with the Numerical Rating Scale (NRS)
timeFrame: Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation
name: Nicolaus M. Kröger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: