Mind-body Medicine for Patients With Malignant Hematological Diseases

Hematologic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03735992
• Other study ID #: RBK02-17-00424
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Universität Duisburg-Essen
• Contact: Holger Cramer, PhD
• Phone: +4971181017860
• Email: holger.cramer[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 31, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Diseases
• Hematologic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Germany	Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin	Stuttgart

Sponsors (2)

Lead Sponsor	Collaborator
Universität Duisburg-Essen	Robert Bosch Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Expectation	Visual Analogue Scale (VAS)	week 0
Other	Treatment Satisfaction	Client Satisfaction Questionnaire (CSQ)	week 12
Primary	General Fatigue	Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale	week 12
Secondary	General Fatigue	Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale	week 24
Secondary	Physical Fatigue	Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale	week 12
Secondary	Physical Fatigue	Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale	week 24
Secondary	Reduced Activity	Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale	week 12
Secondary	Reduced Activity	Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale	week 24
Secondary	Reduced Motivation	Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale	week 12
Secondary	Reduced Motivation	Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale	week 24
Secondary	Mental Fatigue	Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale	week 12
Secondary	Mental Fatigue	Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale	week 24
Secondary	Qaulity of life	Functional Assessment of Cancer Therapy - General (FACT-G)	week 12
Secondary	Qaulity of life	Functional Assessment of Cancer Therapy - General (FACT-G)	week 24
Secondary	Depression	Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)	week 12
Secondary	Depression	Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)	week 24
Secondary	Anxiety	Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)	week 12
Secondary	Anxiety	Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)	week 24
Secondary	Stress	Perceived Stress Scale (PSS)	week 12
Secondary	Stress	Perceived Stress Scale (PSS)	week 24
Secondary	Sleep	Pittsburgh Sleep Quality Index (PSQI)	week 12
Secondary	Sleep	Pittsburgh Sleep Quality Index (PSQI)	week 24
Secondary	Physical activity	Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)	week 12
Secondary	Physical activity	Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)	week 24
Secondary	Fatigability	30-Second Chair Stand Test	week 12
Secondary	Fatigability	30-Second Chair Stand Test	week 24
Secondary	Adverse Events	Number of patients with adverse events	week 12
Secondary	Adverse Events	Number of patients with adverse events	week 24