NCT03735992

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Sep 2017Dec 2026

Study Start

First participant enrolled

September 6, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

9.3 years

First QC Date

November 7, 2018

Last Update Submit

April 10, 2026

Conditions

Hematologic Neoplasms

Keywords

Hematologic NeoplasmsSupportive TherapyFatigueMind-body medicineComplementary and alternative medicine

Outcome Measures

Primary Outcomes (1)

  • General Fatigue

    Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale

    week 12

Secondary Outcomes (25)

  • General Fatigue

    week 24

  • Physical Fatigue

    week 12

  • Physical Fatigue

    week 24

  • Reduced Activity

    week 12

  • Reduced Activity

    week 24

  • +20 more secondary outcomes

Other Outcomes (2)

  • Treatment Expectation

    week 0

  • Treatment Satisfaction

    week 12

Study Arms (2)

Mind-body medicine group program

EXPERIMENTAL

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

Wait list

NO INTERVENTION

Treatment as usual.

Interventions

Mind-body medicine group programBEHAVIORAL

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.

Mind-body medicine group program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Chemotherapy, radiation, or rehabilitation programm during the study period
  • Pregnancy
  • Participation in other studies with behavioral interventions during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin

Stuttgart, 70376, Germany

RECRUITING

MeSH Terms

Conditions

Hematologic NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gustav Dobos, Prof. MD

    Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen

    STUDY DIRECTOR

Central Study Contacts

Holger Cramer, PhD

CONTACT

+4971181017860holger.cramer@med.uni-tuebingen.de

Heidemarie Haller, PhD

CONTACT

+4920172377382heidemarie.haller@uk-essen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 8, 2018

Study Start

September 6, 2017

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

DE(1)