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Trial record 2 of 278261 for:    ALL

Humor Therapy and Distress After Allogeneic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT03593161
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Collaborators:
Deutsche José Carreras Leukämie-Stiftung
Staburo GmbH
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

June 11, 2018
July 19, 2018
July 19, 2018
May 8, 2018
August 2019   (Final data collection date for primary outcome measure)
Distress [ Time Frame: 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)
Same as current
No Changes Posted
  • Hope [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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)
Same as current
Not Provided
Not Provided
 
Humor Therapy and Distress After Allogeneic Stem Cell Transplantation
The Effect of Humor Therapy on Perceived Distress After Allogeneic Stem Cell Transplantation
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).

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Allogeneic Hematopoietic Stem Cell Transplantation
Behavioral: Humor therapy
Clown visits
  • Experimental: Humor therapy
    After baseline assessment (before start of conditioning), patients assigned to the experimental study arm will receive the standard psychosocial care plus weekly clown visits over the course of their inpatient stay for allogeneic stem cell transplantation.
    Intervention: Behavioral: Humor therapy
  • No Intervention: Treatment as usual
    Patients assigned to the control arm will receive the standard psychosocial care over the course of their inpatient stay for allogeneic stem cell transplantation.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
126
Same as current
September 2019
August 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Insufficient German language skills
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Nicolaus M. Kröger, Prof. Dr. +49(0)40-7410-54851 bmt@uke.de
Contact: Angela Scherwath, Dr. +49(0)40-7410-57565 a.scherwath@uke.de
Germany
 
 
NCT03593161
DJCLS 26R/2017
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
  • Deutsche José Carreras Leukämie-Stiftung
  • Staburo GmbH
Principal Investigator: Nicolaus M. Kröger, Prof. Dr. University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation
Universitätsklinikum Hamburg-Eppendorf
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP