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Clinical Trials/NCT03735992
NCT03735992
Recruiting
N/A

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

Universität Duisburg-Essen2 sites in 1 country94 target enrollmentSeptember 6, 2017

Overview

Phase
N/A
Intervention
Mind-body medicine group program
Conditions
Hematologic Neoplasms
Sponsor
Universität Duisburg-Essen
Enrollment
94
Locations
2
Primary Endpoint
General Fatigue
Status
Recruiting
Last Updated
17 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 6, 2017
End Date
December 31, 2026
Last Updated
17 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Holger Cramer

Research Director

Universität Duisburg-Essen

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

Arms & Interventions

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.

Intervention: Mind-body medicine group program

Wait list

Treatment as usual.

Outcomes

Primary Outcomes

General Fatigue

Time Frame: week 12

Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale

Secondary Outcomes

  • Reduced Motivation(week 24)
  • Mental Fatigue(week 24)
  • Depression(week 24)
  • Anxiety(week 24)
  • Sleep(week 24)
  • General Fatigue(week 24)
  • Physical Fatigue(week 24)
  • Reduced Activity(week 24)
  • Qaulity of life(week 24)
  • Adverse Events(week 24)
  • Stress(week 24)
  • Physical activity(week 24)
  • Fatigability(week 24)
  • Physical Fatigue(week 12)
  • Reduced Activity(week 12)
  • Reduced Motivation(week 12)
  • Mental Fatigue(week 12)
  • Qaulity of life(week 12)
  • Depression(week 12)
  • Anxiety(week 12)
  • Stress(week 12)
  • Sleep(week 12)
  • Physical activity(week 12)
  • Fatigability(week 12)
  • Adverse Events(week 12)

Study Sites (2)

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