Trial document





This trial has been registered retrospectively.
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  DRKS00010810

Trial Description

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Title

Yoga as therapeutic intervention in women with breast cancer during chemotherapy

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Trial Acronym

IKoS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Movement-orientated and sport therapeutic interventions have an important role in the treatment concepts to reduce the negative side effects of cancer treatment. One feature which may distinguish Yoga from other movement-orientated interventions is the meditative approach which requires an inner involvement in terms of “an active (emotional) engagement” of practitioners.

This prospective, randomized trial aimes to investigate the impact of yoga on inner congruence and peacefulness harmony (ICPH) with practices in women with stage I-III breast cancer during chemotherapy compared to conventional therapeutic exercises. Also the correlation of ICPH with health-related quality of life, life satisfaction, mindfulness and fatigue will be measured.

Women with breast cancer (stage I-III) undergoing oncological treatment will be randomly enrolled to a physical exercise intervention or a Yoga intervention. Outcomes will be assessed before , after the intervention as well as 3 months after finishing the intervention using standardized questionnaires.

We assume that yoga practice increases patients´ ‘inner correspondence’ stronger than physical exercise does, and that a higher ‘inner correspondence’ correlates with higher values for health-related quality of life, life satisfaction and fatigue directly after the intervention.

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Brief Summary in Scientific Language

Movement-orientated and sport therapeutic interventions have an important role in the treatment concepts to reduce the negative side effects of cancer treatment. One feature which may distinguish Yoga from other movement-orientated interventions is the meditative approach which requires an inner involvement in terms of “an active (emotional) engagement” of practitioners.

This prospective, randomized trial aimes to investigate the impact of yoga on inner correspondence and peacefulness harmony (ICPH) with practices in women with stage I-III breast cancer during chemotherapy compared to conventional therapeutic exercises. Also the correlation of ICPH with health-related quality of life, life satisfaction, mindfulness and fatigue will be measured.

Women with breast cancer (stage I-III) undergoing oncological treatment will be randomly enrolled to a physical exercise intervention or a Yoga intervention. Outcomes will be assessed before , after the intervention as well as 3 months after finishing the intervention using standardized questionnaires.

We assume that yoga practice increases patients´ ‘inner correspondence’ stronger than physical exercise does, and that a higher ‘inner correspondence’ correlates with higher values for health-related quality of life, life satisfaction and fatigue directly after the intervention.

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Organizational Data

  •   DRKS00010810
  •   2016/07/12
  •   [---]*
  •   yes
  •   Approved
  •   3069/11, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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

  •   breast cancer
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   regenerative Iyengar Yoga, group setting (4-8 individuals), 12 weeks, 60 minutes per week, participants received a written instruction for a homebased-training twice a week for 20-minutes
  •   physical exercise, one-to-one sessions, 12 weeks, 60 minutes per week, participants received a written instruction for a home-based training twice a week for 20 minutes
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Inner correspondence (Measurement with a questionnaire at intervention start, in the middle and after the intervention period)

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Secondary Outcome

Quality of life (EORTC C-30), life satisfaction (Brief Multidimensional Life Satisfaction Scale), fatigue (Cancer Fatigue Scale) and mindfulness (Freiburger Achtsamkeits-Inventar), spiritual attitudes and coping with illness (Spiritual/Religious Attitudes and Coping with Illness questionnaire); measurement with questionnaire at intervention start, after the intervention period and three months after the end of intervention

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2011/03/18
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Women with stage I-III breast cancer undergoing cytotoxic (neo)adjuvant or endocrine adjuvant therapy at the moment of intervention
- signed informed consent

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Exclusion Criteria

In case of acute febrile or psychiatric diseases, patients were excluded from the study. Also women who had experiences in practicing yoga were not included.

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Addresses

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    • Klinikum rechts der Isar der TU München
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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    • Universität Witten / HerdeckeProfessur für Lebensqualität, Spiritualität und Coping
    • Mr.  Univ. Prof. Dr. med  Arndt  Büssing 
    • Gerhard-Kienle-Weg 4
    • 58313  Herdecke
    • Germany
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    • Professur für Lebensqualität, Spiritualität und CopingUniversität Witten / Herdecke
    • Mr.  Univ.-Prof. Dr.med.  Arndt  Büssing 
    • Gerhard-Kienle-Weg 4
    • 58313  Herdecke
    • Germany
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Sources of Monetary or Material Support

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    • Professur für Lebensqualität, Spiritualität und CopingUniversität Witten / Herdecke
    • Mr.  Univ.-Prof. Dr.med.  Arndt  Büssing 
    • Gerhard-Kienle-Weg 4
    • 58313  Herdecke
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/09/25
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.