Mind-body Medicine for Patients With Malignant Hematological Diseases

November 21, 2023 updated by: Holger Cramer, Universität Duisburg-Essen

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.

Study Overview

Status

Recruiting

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Stuttgart, Germany, 70376
        • Recruiting
        • Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Wait list
Treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Fatigue
Time Frame: week 12
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Fatigue
Time Frame: week 24
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
week 24
Physical Fatigue
Time Frame: week 12
Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale
week 12
Physical Fatigue
Time Frame: week 24
Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale
week 24
Reduced Activity
Time Frame: week 12
Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale
week 12
Reduced Activity
Time Frame: week 24
Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale
week 24
Reduced Motivation
Time Frame: week 12
Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale
week 12
Reduced Motivation
Time Frame: week 24
Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale
week 24
Mental Fatigue
Time Frame: week 12
Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale
week 12
Mental Fatigue
Time Frame: week 24
Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale
week 24
Qaulity of life
Time Frame: week 12
Functional Assessment of Cancer Therapy - General (FACT-G)
week 12
Qaulity of life
Time Frame: week 24
Functional Assessment of Cancer Therapy - General (FACT-G)
week 24
Depression
Time Frame: week 12
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
week 12
Depression
Time Frame: week 24
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
week 24
Anxiety
Time Frame: week 12
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
week 12
Anxiety
Time Frame: week 24
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
week 24
Stress
Time Frame: week 12
Perceived Stress Scale (PSS)
week 12
Stress
Time Frame: week 24
Perceived Stress Scale (PSS)
week 24
Sleep
Time Frame: week 12
Pittsburgh Sleep Quality Index (PSQI)
week 12
Sleep
Time Frame: week 24
Pittsburgh Sleep Quality Index (PSQI)
week 24
Physical activity
Time Frame: week 12
Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)
week 12
Physical activity
Time Frame: week 24
Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)
week 24
Fatigability
Time Frame: week 12
30-Second Chair Stand Test
week 12
Fatigability
Time Frame: week 24
30-Second Chair Stand Test
week 24
Adverse Events
Time Frame: week 12
Number of patients with adverse events
week 12
Adverse Events
Time Frame: week 24
Number of patients with adverse events
week 24

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Expectation
Time Frame: week 0
Visual Analogue Scale (VAS)
week 0
Treatment Satisfaction
Time Frame: week 12
Client Satisfaction Questionnaire (CSQ)
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Gustav Dobos, Prof. MD, Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2017

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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