Trial document




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  DRKS00006015

Trial Description

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Title

Effect of moderate running training and mindfulness based stress reduction (MBSR) on imme system and quality of life in women with breast cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Investigation of stress Management and immune System in women with stage I-III breast cancer undergoing aromatase Inhibitor therapy. The participants will be randomised in 3 Groups: 8 weeks of moderate running Training, 8 weeks MBSR training and controll Group. After 8 weeks of Training period there will be a follow up period of 4 more months.

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Brief Summary in Scientific Language

effect of 8-weeks of moderate running Training, compared to 8 weeks of MBSR Training on peripheral blood Levels of prolactin and cortisol (measured in the afternoon) and Quality of Life in women with breast cancer in stage I-III undergoing aromatase Inhibitor therapy. Cortisol, prolactin and Quality of life should be measured every months over a period of 6 months (= 8 weeky Training period, 4 months of follow up).

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006015
  •   2014/03/24
  •   [---]*
  •   yes
  •   Approved
  •   AS 25(bB)/2014, Ethik-Kommission der Landesärztekammer Brandenburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C50.9 -  Malignant neoplasm: Breast, unspecified
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Interventions/Observational Groups

  •   8 weeks of MBSR-Group training (once a week, 150 min, size of Group: 10 participants). Monthly control of cortisol, prolactin blood level and assessment of Quality of life over a period of 6 months (8 weeks training period, 4 months follow up).
  •   8 weeks of moderate running Training (once a week, 150 min physical exercise). Monthly control of cortisol, prolactin blood level and assessment of Quality of life over a period of 6 months (8 weeks group training period, 4 months follow up). Size of group: 10 participants.
  •   Control Group. Monthly Evaluation of cortisol, prolactin and assessment of Quality of life over a period of 6 months. Participants of the control group dont`t take part in any training.
    Size of control Group: 10.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group), Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

monthly Evaluation of cortisol and prolactin blood levels. Cortisol and prolactin levels are analysed in the afternoon. Evaluation period: 6 months (T1 - T 6).

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Secondary Outcome

monthly assessment of Quality of Life by using the questionnaires of the EORTC-Quality-of-Life-Research-Group:
QLQ-C30 Version 3.0 and QLQ-BR23).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2014/05/14
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   50   Years
  •   79   Years
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Additional Inclusion Criteria

postmeopausal women with breast cancer in stage I-III (TNM: T1-4 N0-3 M0), Hormon receptor positiv,undergoing aromatase Inhibitor therapy, 50-79 years old, Minimum distance of time to last chemotherapy or radiotherapy 3 months

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Exclusion Criteria

mental disorders
Treatment with corticosteroids
metastasis
distance of time to chemotherapy < 3 months
distance of time to radiotherapy < 3 months

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Addresses

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    • Rehaklinik Ahrenshoop (seit 01.01.2019)
    • Mr.  Dr. med. Dr. phil.   Johannes  Mattes 
    • Dorfstrasse 55
    • 18347  Ahrenshoop
    • Germany
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    • Europa-Universität ViadrinaFakultät für Kulturwissenschaften
    • Mr.  Prof. Dr. phil. Dipl.Psych.  Stefan  Schmidt 
    • Postfach 1786
    • 15207  Frankfurt (Oder)
    • Germany
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    • Rehaklinik Ahrenshoop
    • Mr.  Dr. med. Dr. phil.  Johannes  Mattes 
    • Dorfstrasse 55
    • 18347  Ahrenshoop
    • Germany
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    • Rehaklinik Ahrenshoop (seit 01.01.2019)
    • Mr.  Dr. med. Dr. phil.  Johannes  Mattes 
    • Dorfstrasse 55
    • 18347  Ahrenshoop
    • Germany
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Sources of Monetary or Material Support

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    • Onkologische Schwerpunktpraxis
    • Mr.  Dr. med. M.A.  Johannes  Mattes 
    • Hochstrasse 29
    • 14770   Brandenburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/03/31
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Trial Publications, Results and other Documents

  •   Die Studie wird als Monografie im TectumVerlag veröffentlicht (erscheint März 2017) unter der ISBN 978-3-8288-3907-6 (436 Seiten)
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* This entry means the parameter is not applicable or has not been set.