Trial document




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  DRKS00011521

Trial Description

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Title

Mindful walking in patients with breast cancer - a randomized pragmatic pilot study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Objective: Breast cancer patients experience often limited quality of life, also after completion of the primary therapies. The aim of this two-armed randomized controlled exploratory pragmatic pilot study is to explore the feasibility and effects of an 8-week complex intervention program, consisting of walking in combination with mindfulness training, in comparison to a control group.

Methods: We include 2 x 30-40 breast cancer patients who had undergone surgery due to their breast cancer disease and have completed their primary therapy (such as surgery, chemotherapy, radiation) since at least 6 months.
Patients in the intervention group will get an 8 week course of "Mindful Walking", a combination of mindfulness meditation and intensive walking once weekly for 90 minutes. In addition, the patients will receive instructions for home practice, such as audiotapes and written instructions.The control group receives a course in Walking over 8 weeks.
Outcomes: perceived stress (PSQ), disease-specific quality of life (FACT-B, WHO-BREF), cancer fatigue scale (CFS-D), self-efficacy (ASKU), anxiety and depression (HADS) , Questions on autonomic regulation (T-HKF version 2.4), pain (NRS 1-10).
Further standardized queries and qualitative surveys related to the intervention:
A) Satisfaction with the intervention, subjectively perceived effectiveness overall and related to possible side effects / residuals of the oncological therapy on the basis of standardized questions and guidance-oriented interviews within focus groups in the intervention group.
B) Feasibility and adherence of the intervention on the basis of the frequency of exercise and intensity documented in a patient's diary and on the basis of interviews with focus groups in the intervention arm.
The study was submitted to the Ethics Committee (EC) of the Charité in its original version on 15.06.16 and received a positive vote on 30.06.16. The study was changed until the actual beginning, these changes were presented to the same EC in 3 amendments, no objections were raised by the EC.
Changes Amendment 1 (EC confirmation 29.07.16): • Inclusion criterion: Stress load based on a VAS> 4 (VAS 0-10) was added.• Outcome parameters: a questionnaire on Cancer Related Fatigue (Cancer Fatigue Scale - Havelhöher Constitution Questionnaire (S-HKF), 12 questions) and autonomous regulatory capacity (Trait - Autonomous Regulation Scale - Havelhöher Constitutional Questionnaire (T-HKF), 19 questions) were added • Study intervention: The control group will receive brief verbal counseling and written information (Handout: Information sheet on sport and exercise in cancer of the german cancer information service) on sports and exercise in cancer
Amendment 2 (EC confirmation 18.10.16): • Inclusion criterion: Because of breast cancer operated patients, • The randomization should be stratified according to the stratification variables: - Chemotherapy: ever received / never received; current antihormonal therapy medication / no currant antihormonal therapy
Amendment 3 (EC confirmation 12.07.17):• The control group receives an intervention consisting of moderate walking (about 4 km / h) without sticks. The patients are divided into groups of up to 10 participants. The walking takes place in the fresh air under supervision of a Nordic Walking trainer over 90 minutes. The course meets regularly once a week over an eight weeks period.
In addition, change of the original study title in "Walking in patients with breast cancer - a randomized pragmatic pilot study".

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Organizational Data

  •   DRKS00011521
  •   2016/12/21
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  •   yes
  •   Approved
  •   EA1/201/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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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

  •   The intervention consists of a course "mindful walking" over a period of 8 weeks. The course will be held once weekly 90 minutes in small groups under th guidance of qualified trainers. In the course, various types of mindfulness mediation will be taught, practiced and reflected and combined with walking exercises. In addition, course contents should be practiced as often as possible at home by the participants. Therefor the participants receive written instructions and audio CDs and shall document the application frequency and intensity in a patient´s diary.
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    The control group receives an 8-week course in moderate walking (walking, 3-4 km / h) without sticks once a week over 90 minutes and once a consultation on the impact of physical activity in cancer patients. The course is led by a walking trainer. The participants are invited to practice at home.
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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)
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The aim of the study is to assess the effects of the intervention on different aspects of quality of life and mental condition. Since this is a pilot study, no primary endpoint is defined.

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Secondary Outcome

Quality of life (general and disease-specific) on the basis of the World Health Organization Quality of Life - BREF Questionnaire (WHOQOL-BREF) and the Functional Assessment of Cancer Therapy - General Questionnaire (FACT-G)
• Perceived Stress Questionnaire (PSQ)
• Self-efficacy using the General Self-Efficacy Short-Term Scale (ASKU)
• Mindfulness, based on the Freiburg Questionnaire on Mindfulness (FFA)
• Anxiety and Depression Scale (HADS)
• Pain on the basis of a numerical rating scale
• Cancer related fatigue based on the German Cancer Fatigue Scale (CFS-D) in the Havelhöher constitutional questionnaire (S-HKF), version 2.4
• Trait Autonomic Regulation (TaR) in the Havelhöher constitutional questionnaire (T-HKF), version 2.4
Further standardized queries and qualitative surveys related to the intervention:
• Satisfaction with the intervention, subjectively perceived effectiveness overall and related to possible side effects / residuals of oncological therapy on the basis of standardized questions and guide-oriented interviews within focus groups in the intervention group.
• Feasibility and adherence of the intervention on the basis of the frequency of exercise and intensity documented by the patient in the patient journal and on the basis of guide-based surveys in focus groups in the intervention group

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/09
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Due to their breast cancer operated patients who have completed further tumor-specific adjuvant or neoadjuvant primary therapy (e.g. chemotherapy, radiation) for at least 6 months (anti-hormonal therapy can be continued).
- Age ≥18 years
- The patient must be able to perform the study intervention
- Present oral and written consent to participate in the study
- Stress loading using a visual analog scale of> 4 (VAS 0-10)

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Exclusion Criteria

• Known distant metastases
• Current chemotherapy, radiotherapy
• Severe mental and / or additional organic disease
• Clinically relevant cardiac arrhythmias or angina pectoris
• Severe pulmonary disease
• Inadequate walking ability or gait disorder (including neurological deficits, endoprostheses that lead to gait uncertainty)
• Regular meditation practice (several times per week)
• Beginning of courses on meditation, relaxation, MBSR, yoga, Qi Gong planned in the next 16 weeks
• Planned inpatient, partial or outpatient rehabilitation in the next 16 weeks
• Participation in other intervention studies realted to walking or meditation
• Insufficient knowledge of the German language

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Addresses

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    • Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité Universitätsmedizin Berlin
    • Luisenstr. 57
    • 10117  Berlin
    • Germany
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    • Klinik für Gynäkologie, Charité Universitätsmedizin Berlin
    • Mr.  Prof. Dr. med.  Jens-Uwe  Blohmer 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Institut f. Sozialmedizin, Epidemiologie u. Gesundheitsökonomie, Charité - Universitätsmedizin Berlin
    • Ms.  Dr.  Miriam  Ortiz 
    • Luisenstr. 57
    • 10117  Berlin
    • Germany
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    • Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité Universitätsmedizin Berlin
    • Ms.  Margit  Cree 
    • Luisenstr. 57
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité Universitätsmedizin Berlin
    • Luisenstr. 57
    • 10117  Berlin
    • Germany
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    • Eden-Stiftung
    • Königsteiner Str. 107
    • 65812 
    • Germany
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Status

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

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