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Recruiting NCT03735992

Mind-body Medicine for Patients With Malignant Hematological Diseases

No phase Interventional Hematologic Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mind-body medicine group program.
Who it may be relevant to
Registry conditions: Hematologic Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Mind-body Medicine as a Supportive Strategy for Patients With Malignant Hematological Diseases: a Randomized Controlled Trial

Overview

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • General Fatigue [Time frame: week 12]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin — Stuttgart

Identifiers

NCT: NCT03735992 · RBK02-17-00424

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗