Hematologic NeoplasmsNCT03735992
Mind-body Medicine for Patients With Malignant Hematological Diseases
A study testing Mind-body medicine group program in people with Hematologic Neoplasms, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
This randomized controlled trial aims to investigate the effectiveness of a mind-body group program as a supprtivemanagement strategy for fatigue in patients with malignant hematological diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms
- What is being tested?
- Mind-body medicine group program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteGermany
- Study dates
- 6 Sep 2017to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with malignant hematological diseases in complete remission after primary chemotherapy and/or radiation
- Physical and mental ability to attent 8 of 11 group units
Who cannot join
- Chemotherapy, radiation, or rehabilitation programm during the study period
- Pregnancy
- Participation in other studies with behavioral interventions during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin
Stuttgart, 70376
Walter E. Aulitzky, Prof. MD, walter.aulitzky@rbk.de
Maria M. Winkler, marcela.winkler@rbk.de
About this study
Official title: Mind-body Medicine as a Supportive Strategy for Patients With Malignant Hematological Diseases: a Randomized Controlled Trial
This randomized controlled trial aims to investigate the effectiveness of a mind-body group program as a supprtivemanagement strategy for fatigue in patients with malignant hematological diseases.
- Conditions
- Hematologic Neoplasms
- Being tested
- Mind-body medicine group program
- Keywords
- Hematologic Neoplasms, Supportive Therapy, Fatigue, Mind-body medicine, Complementary and alternative medicine
- Medical subject headings
- Hematologic Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-body medicine group programBehavioural
The group program is mainly based on MBSR. It further integrates elements of the mind-body medicine cancer program of the Benson-Henry Mind/Body Medical Institute at Harvard Medical School which is rooted in psychoneuroendocrinology and focuses on relaxation techniques, exercise, cognitive restructuring, diet, and social support. In addition, naturopathic methods of selfregulation and self-care are incorporated.
| Study group | Role | What they receive |
|---|---|---|
| Mind-body medicine group program | Experimental | Patients recieve an 11-week mind-body medicine group program including elements of mindfullness based stress reduction (MBSR), yoga, and education + treatment as usual. Receives: Behavioral: Mind-body medicine group program |
| Wait list | No intervention | Treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Fatigue
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
Measured: week 12
Secondary outcomes (25)
General Fatigue
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
Measured: week 24
Physical Fatigue
Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale
Measured: week 12
Physical Fatigue
Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale
Measured: week 24
Reduced Activity
Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale
Measured: week 12
Reduced Activity
Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale
Measured: week 24
Reduced Motivation
Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale
Measured: week 12
Reduced Motivation
Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale
Measured: week 24
Mental Fatigue
Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale
Measured: week 12
Mental Fatigue
Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale
Measured: week 24
Qaulity of life
Functional Assessment of Cancer Therapy - General (FACT-G)
Measured: week 12
Qaulity of life
Functional Assessment of Cancer Therapy - General (FACT-G)
Measured: week 24
Depression
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
Measured: week 12
Depression
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
Measured: week 24
Anxiety
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Measured: week 12
Anxiety
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Measured: week 24
Stress
Perceived Stress Scale (PSS)
Measured: week 12
Stress
Perceived Stress Scale (PSS)
Measured: week 24
Sleep
Pittsburgh Sleep Quality Index (PSQI)
Measured: week 12
Sleep
Pittsburgh Sleep Quality Index (PSQI)
Measured: week 24
Physical activity
Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)
Measured: week 12
Physical activity
Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)
Measured: week 24
Fatigability
30-Second Chair Stand Test
Measured: week 12
Fatigability
30-Second Chair Stand Test
Measured: week 24
Adverse Events
Number of patients with adverse events
Measured: week 12
Adverse Events
Number of patients with adverse events
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start6 Sep 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Bosch Medical Center
- Responsible party
- Principal investigator, Holger Cramer, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof. MD, Study director, Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735992
- Sponsor's protocol ID
- RBK02-17-00424
- Status last verified
- Apr 2026
- First submitted
- 7 Nov 2018
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-body Medicine as a Supportive Strategy for Patients With Malignant Hematological Diseases: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03735992
- Acronym / sponsor ID
- RBK02-17-00424
- Conditions
- Hematologic Neoplasms
- Keywords
- Hematologic Neoplasms, Supportive Therapy, Fatigue, Mind-body medicine, Complementary and alternative medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- Robert Bosch Medical Center
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Nov 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 randomized controlled trial aims to investigate the effectiveness of a mind-body group program as a supprtivemanagement strategy for fatigue in patients with malignant hematological diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mind-body medicine group program | Experimental | Behavioral: Mind-body medicine group programPatients recieve an 11-week mind-body medicine group program including elements of mindfullness based stress reduction (MBSR), yoga, and education + treatment as usual. |
| Wait list | No intervention | –Treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with malignant hematological diseases in complete remission after primary chemotherapy and/or radiation
- Physical and mental ability to attent 8 of 11 group units
Key exclusion criteria (3 listed)
- Chemotherapy, radiation, or rehabilitation programm during the study period
- Pregnancy
- Participation in other studies with behavioral interventions during the study period
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 |
|---|---|---|
| Mind-body medicine group programThe group program is mainly based on MBSR. It further integrates elements of the mind-body medicine cancer program of the Benson-Henry Mind/Body Medical Institute at Harvard Medical School which is rooted in psychoneuroendocrinology and focuses on relaxation techniques, exercise, cognitive restructuring, diet, and social support. In addition, naturopathic methods of selfregulation and self-care are incorporated. | Behavioural | Mind-body medicine group program |
Primary outcome
General Fatigue
Time frame: week 12
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
25 secondary outcomes
General Fatigue
Time frame: week 24
Physical Fatigue
Time frame: week 12
Physical Fatigue
Time frame: week 24
Reduced Activity
Time frame: week 12
Reduced Activity
Time frame: week 24
Reduced Motivation
Time frame: week 12
Reduced Motivation
Time frame: week 24
Mental Fatigue
Time frame: week 12
Mental Fatigue
Time frame: week 24
Qaulity of life
Time frame: week 12
Qaulity of life
Time frame: week 24
Depression
Time frame: week 12
Depression
Time frame: week 24
Anxiety
Time frame: week 12
Anxiety
Time frame: week 24
Stress
Time frame: week 12
Stress
Time frame: week 24
Sleep
Time frame: week 12
Sleep
Time frame: week 24
Physical activity
Time frame: week 12
Physical activity
Time frame: week 24
Fatigability
Time frame: week 12
Fatigability
Time frame: week 24
Adverse Events
Time frame: week 12
Adverse Events
Time frame: week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided. Upon reasonable request.
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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.
Gustav Dobos, Prof. MD study director
Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-body medicine group program in people with Hematologic Neoplasms, run by Universität Duisburg-Essen 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 3 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holger Cramer, PhD (+4971181017860, holger.cramer@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Fatigue (time frame: week 12). 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 15 Apr 2026.