Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011122

Trial Description

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Title

Motivational-volitional intervention - exercise after breast cancer

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Trial Acronym

MoVo-BnB

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URL of the Trial

https://www.ph-freiburg.de/institut-fuer-alltagskultur-bewegung-und-gesundheit/fachrichtungen/gesundheitspaedagogik/forschung/projekte/movo-bnb.html

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Brief Summary in Lay Language

[---]*

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Brief Summary in Scientific Language

The aim of the study is to develop a motivational-volitional intervention considering current pedagogical-didactic, psychological and exercise scientific evidence and evaluate the effectiveness of this intervention.

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Organizational Data

  •   DRKS00011122
  •   2016/10/13
  •   [---]*
  •   yes
  •   Approved
  •   F-2014-091, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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

  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Control group - medical rehabilitation as usual
  •   Intervention group - medical rehabilitation and motivational-volitional intervention - exercise after breast cancer
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Supportive care
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Physical activity (BSA-questionnaire), at four time points, baseline (begin reha), after three weeks (end of reha), 6 and 12 months after discharge

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Secondary Outcome

u.a. quality of life (EORTC-QLQ C30), fatigue (EORTC QLQ FA13), depression (PHQ-9), self-efficiacy (generalized self-efficacy
scale), planning competence (action planing and cooping planing questionnaire), acceptance (only IG, heiQ-program) at four time points, baseline (begin reha), after three weeks (end of reha), 6 and 12 months after discharge

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/03/31
  •   800
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Diagnosis breastcancer, average physical activity four weeks before rehabilitation less than 60 minutes per week.

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Exclusion Criteria

Age less then 18, lack of German language skills in speaking and writing, severe impairment of vision or hearing, severe mental impairment as well as a significantly reduced health.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Pädagogische Hochschule Freiburg Public Health & Health Education
    • Ms.  Prof. Dr. med.  Eva-Maria  Bitzer 
    • Kunzenweg 21
    • 79117  Freiburg
    • Germany
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    • Pädagogische Hochschule Freiburg Institut für Alltagskultur, Bewegung und Gesundheit Public Health & Health Education
    • Ms.  Prof. Dr. med.  Eva-Maria  Bitzer 
    • Kunzenweg 21
    • 79117  Freiburg
    • Germany
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    • Pädagogische Hochschule Freiburg Public Health & Health Education
    • Ms.  MA  Leonie  Adams 
    • Kunzenweg 21
    • 79117  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung - BundAbteilung Rehabilitation
    • 10704  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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