Mind-body Medicine for Patients With Malignant Hematological Diseases

Not Applicable

Recruiting

• Conditions: Hematologic Neoplasms
• Interventions: Behavioral: Mind-body medicine group program

• Registration Number: NCT03735992
• Lead Sponsor: Universität Duisburg-Essen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-06
• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-08
• Status Verified: 2024-12
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-07-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mind-body medicine group program	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.

Primary Outcome Measures

Name	Time	Method
General Fatigue	week 12	Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin; 🇩🇪 Stuttgart, Germany