Mind-body Medicine for Patients With Malignant Hematological Diseases

Sponsor

Universität Duisburg-Essen (Other)

Overall Status

Recruiting

CT.gov ID

NCT03735992

Collaborator

Robert Bosch Medical Center (Other)

Enrollment

Location

Arms

75.8

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Neoplasms	Behavioral: Mind-body medicine group program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 6, 2017

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.	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.
No Intervention: Wait list Treatment as usual.

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.

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.

No Intervention: Wait list

Treatment as usual.

Outcome Measures

Primary Outcome Measures

General Fatigue [week 12]
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale

Secondary Outcome Measures

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

Other Outcome Measures

Treatment Expectation [week 0]
Visual Analogue Scale (VAS)
Treatment Satisfaction [week 12]
Client Satisfaction Questionnaire (CSQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin	Stuttgart		Germany	70376

Sponsors and Collaborators

Universität Duisburg-Essen
Robert Bosch Medical Center

Investigators

Study Director: Gustav Dobos, Prof. MD, Department of Internal and Integrative Medicine | Kliniken Essen-Mitte | Faculty of Medicine | University of Duisburg-Essen