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

Not Applicable

• Conditions: C50.9; Breast, unspecified

• Registration Number: DRKS00011521
• Lead Sponsor: Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité Universitätsmedizin Berlin

Brief Summary

Both study interventions were positively evaluated by patients and showed possible pre-post effects in disease-specific health-related outcomes without differences between groups. The qualitative analysis results indicate that different resources and coping strategies were addressed by the 2 study interventions.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-21
• Study Completion: 2019-11-26
• Results First Posted: 2022-01-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 51

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

• 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.