Humor Therapy and Distress After Allogeneic Stem Cell Transplantation

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

The Effect of Humor Therapy on Perceived Distress After Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03593161
• Other study ID #: DJCLS 26R/2017
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2018
• Est. completion date: September 2019

Study information

• Verified date: July 2018
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Nicolaus M. Kröger, Prof. Dr.
• Phone: +49(0)40-7410-54851
• Email: bmt[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: September 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Admission for allogeneic transplantation at the University Medical Center Hamburg-Eppendorf

Exclusion Criteria:

• Insufficient German language skills

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Stem Cell Transplantation

Intervention

Behavioral:
• Humor therapy
Clown visits

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Deutsche José Carreras Leukämie-Stiftung, Staburo GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distress	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)	Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28)
Secondary	Hope	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)	Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28)
Secondary	Depressive symptoms	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)	Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +14 and +28)
Secondary	Anxiety symptoms	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)	Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +14 and +28)
Secondary	Pain intensity measured with the Numerical Rating Scale (NRS)	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)	Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28)