NCT03593161

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

June 11, 2018

Last Update Submit

July 18, 2018

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Keywords

stem cell transplantationallogeneichumor therapydistresssupportive care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Hope

    Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28)

  • Depressive symptoms

    Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +14 and +28)

  • Anxiety symptoms

    Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +14 and +28)

  • 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)

Study Arms (2)

Humor therapy

EXPERIMENTAL

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.

Behavioral: Humor therapy

Treatment as usual

NO INTERVENTION

Patients assigned to the control arm will receive the standard psychosocial care over the course of their inpatient stay for allogeneic stem cell transplantation.

Interventions

Humor therapyBEHAVIORAL

Clown visits

Humor therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Insufficient German language skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Study Officials

  • Nicolaus M. Kröger, Prof. Dr.

    University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolaus M. Kröger, Prof. Dr.

CONTACT

+49(0)40-7410-54851bmt@uke.de

Angela Scherwath, Dr.

CONTACT

+49(0)40-7410-57565a.scherwath@uke.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2018

First Posted

July 19, 2018

Study Start

May 8, 2018

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

DE(1)