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Mind-body Medicine for Patients With Malignant Hematological Diseases

Primary Purpose

Hematologic Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mind-body medicine group program
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Neoplasms focused on measuring Hematologic Neoplasms, Supportive Therapy, Fatigue, Mind-body medicine, Complementary and alternative medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und PalliativmedizinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mind-body medicine group program

Wait list

Arm Description

Patients recieve an 11-week mind-body medicine group program including elements of mindfullness based stress reduction (MBSR), yoga, and education + treatment as usual.

Treatment as usual.

Outcomes

Primary Outcome Measures

General Fatigue
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale

Secondary Outcome Measures

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

Full Information

First Posted
November 7, 2018
Last Updated
December 5, 2022
Sponsor
Universität Duisburg-Essen
Collaborators
Robert Bosch Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03735992
Brief Title
Mind-body Medicine for Patients With Malignant Hematological Diseases
Official Title
Mind-body Medicine as a Supportive Strategy for Patients With Malignant Hematological Diseases: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
Collaborators
Robert Bosch Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Neoplasms
Keywords
Hematologic Neoplasms, Supportive Therapy, Fatigue, Mind-body medicine, Complementary and alternative medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mind-body medicine group program
Arm Type
Experimental
Arm Description
Patients recieve an 11-week mind-body medicine group program including elements of mindfullness based stress reduction (MBSR), yoga, and education + treatment as usual.
Arm Title
Wait list
Arm Type
No Intervention
Arm Description
Treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
Mind-body medicine group program
Intervention Description
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 Measure Information:
Title
General Fatigue
Description
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
Time Frame
week 12
Secondary Outcome Measure Information:
Title
General Fatigue
Description
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
Time Frame
week 24
Title
Physical Fatigue
Description
Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale
Time Frame
week 12
Title
Physical Fatigue
Description
Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale
Time Frame
week 24
Title
Reduced Activity
Description
Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale
Time Frame
week 12
Title
Reduced Activity
Description
Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale
Time Frame
week 24
Title
Reduced Motivation
Description
Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale
Time Frame
week 12
Title
Reduced Motivation
Description
Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale
Time Frame
week 24
Title
Mental Fatigue
Description
Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale
Time Frame
week 12
Title
Mental Fatigue
Description
Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale
Time Frame
week 24
Title
Qaulity of life
Description
Functional Assessment of Cancer Therapy - General (FACT-G)
Time Frame
week 12
Title
Qaulity of life
Description
Functional Assessment of Cancer Therapy - General (FACT-G)
Time Frame
week 24
Title
Depression
Description
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
Time Frame
week 12
Title
Depression
Description
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
Time Frame
week 24
Title
Anxiety
Description
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time Frame
week 12
Title
Anxiety
Description
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time Frame
week 24
Title
Stress
Description
Perceived Stress Scale (PSS)
Time Frame
week 12
Title
Stress
Description
Perceived Stress Scale (PSS)
Time Frame
week 24
Title
Sleep
Description
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
week 12
Title
Sleep
Description
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
week 24
Title
Physical activity
Description
Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)
Time Frame
week 12
Title
Physical activity
Description
Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)
Time Frame
week 24
Title
Fatigability
Description
30-Second Chair Stand Test
Time Frame
week 12
Title
Fatigability
Description
30-Second Chair Stand Test
Time Frame
week 24
Title
Adverse Events
Description
Number of patients with adverse events
Time Frame
week 12
Title
Adverse Events
Description
Number of patients with adverse events
Time Frame
week 24
Other Pre-specified Outcome Measures:
Title
Treatment Expectation
Description
Visual Analogue Scale (VAS)
Time Frame
week 0
Title
Treatment Satisfaction
Description
Client Satisfaction Questionnaire (CSQ)
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Holger Cramer, PhD
Email
holger.cramer@med.uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Heidemarie Haller, PhD
Phone
+4920172377382
Email
heidemarie.haller@uk-essen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustav Dobos, Prof. MD
Organizational Affiliation
Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
Official's Role
Study Director
Facility Information:
Facility Name
Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter E. Aulitzky, Prof. MD
Email
walter.aulitzky@rbk.de
First Name & Middle Initial & Last Name & Degree
Maria M. Winkler
Email
marcela.winkler@rbk.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Upon reasonable request.

Learn more about this trial

Mind-body Medicine for Patients With Malignant Hematological Diseases

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