Mind-body Medicine for Patients With Malignant Hematological Diseases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversität Duisburg-Essen

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Chemotherapy, radiation, or rehabilitation programm during the study period

Pregnancy

Participation in other studies with behavioral interventions during the study period

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mind-body medicine group program

    Behavioral

    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.

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Mind-body medicine group programExperimental treatment 1 intervention
Group B: Wait listNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

General Fatigue

Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale

Time frame
week 12

Secondary outcomes

1

General Fatigue

Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale

Time frame
week 24
2

Physical Fatigue

Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale

Time frame
week 12
3

Physical Fatigue

Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale

Time frame
week 24
4

Reduced Activity

Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale

Time frame
week 12

Other outcomes

1

Treatment Expectation

Visual Analogue Scale (VAS)

Time frame
week 0
2

Treatment Satisfaction

Client Satisfaction Questionnaire (CSQ)

Time frame
week 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universität Duisburg-Essen

Lead sponsor

Robert Bosch Medical Center

Collaborator