Allogeneic Hematopoietic Stem Cell TransplantationNCT03593161
Humor Therapy and Distress After Allogeneic Stem Cell Transplantation
A study testing Humor therapy in people with Allogeneic Hematopoietic Stem Cell Transplantation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation
- What is being tested?
- Humor therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteGermany
- Study dates
- 8 May 2018to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Admission for allogeneic transplantation at the University Medical Center Hamburg-Eppendorf
Who cannot join
- Insufficient German language skills
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: 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).
Read the 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.
- Being tested
- Humor therapy
- Keywords
- stem cell transplantation, allogeneic, humor therapy, distress, supportive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humor therapyBehavioural
Clown visits
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28)
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)
Measured: Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +14 and +28)
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)
Measured: 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)
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)
Measured: Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start8 May 2018
- Primary completionAug 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche José Carreras Leukämie-Stiftung, Staburo GmbH
- Responsible party
- Sponsor
- Investigators
- Nicolaus M. Kröger, Prof. Dr., Principal investigator, University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593161
- Sponsor's protocol ID
- DJCLS 26R/2017
- Status last verified
- Jul 2018
- First submitted
- 11 Jun 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Humor Therapy on Perceived Distress After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03593161
- Acronym / sponsor ID
- DJCLS 26R/2017
- Keywords
- stem cell transplantation, allogeneic, humor therapy, distress, supportive care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Deutsche José Carreras Leukämie-Stiftung, Staburo GmbH
- Study start
- 8 May 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Humor therapy | Experimental | Behavioral: Humor therapyAfter 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Admission for allogeneic transplantation at the University Medical Center Hamburg-Eppendorf
Key exclusion criteria (1 listed)
- Insufficient German language skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Humor therapyClown visits | Behavioural | Humor therapy |
Primary outcome
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)
4 secondary outcomes
Hope
Time frame: Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28)
Depressive symptoms
Time frame: Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +14 and +28)
Anxiety symptoms
Time frame: 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)
Time frame: Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolaus M. Kröger, Prof. Dr. principal investigator
University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humor therapy in people with Allogeneic Hematopoietic Stem Cell Transplantation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolaus M. Kröger, Prof. Dr. (+49(0)40-7410-54851, bmt@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.