C50.9
Conditions
Interventions
Group 1: 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 th
Sponsors
Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactMargit Cree
Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité Universitätsmedizin Berlin
Outcome results
None listed