Mind-body Medicine for Patients With Malignant Hematological Diseases

NCT ID: NCT03735992

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-06

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hematologic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mind-body medicine group program

Patients recieve an 11-week mind-body medicine group program including elements of mindfullness based stress reduction (MBSR), yoga, and education + treatment as usual.

Group Type EXPERIMENTAL

Mind-body medicine group program

Intervention Type BEHAVIORAL

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.

Wait list

Treatment as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mind-body medicine group program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Chemotherapy, radiation, or rehabilitation programm during the study period
* Pregnancy
* Participation in other studies with behavioral interventions during the study period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Robert Bosch Medical Center

OTHER

Sponsor Role collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Holger Cramer

Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gustav Dobos, Prof. MD

Role: STUDY_DIRECTOR

Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen

Locations

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Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin

Stuttgart, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Holger Cramer, PhD

Role: CONTACT

+4971181017860

Heidemarie Haller, PhD

Role: CONTACT

+4920172377382

Facility Contacts

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Walter E. Aulitzky, Prof. MD

Role: primary

Maria M. Winkler

Role: backup

Other Identifiers

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RBK02-17-00424

Identifier Type: -

Identifier Source: org_study_id

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