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

Authors
Category Primary study
Registry of TrialsGerman Clinical Trials Register
Year 2016
INTERVENTION: Intervention 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 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. Intervention 2: 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. CONDITION: C50.9 ‐ Malignant neoplasm: Breast, unspecified 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. 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 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)
Epistemonikos ID: c109a697ae31e8aa4d80fbc000f8a764f48ceb0f
First added on: Apr 23, 2024