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Mind-body medicine for lifestyle change in patients with breast cancer in a curative situation: A randomized controlled trial

Mind-body medicine for lifestyle change in patients with breast cancer in a curative situation: A randomized controlled trial - MILEMA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038545
Enrollment
80
Registered
2025-12-04
Start date
2025-12-19
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer patients in a curative situation C50

Interventions

Group 1: Intervention group: structured mind-body medicine program based on the Essen model, 11 weekly group sessions of 6 hours each. The content integrates evidence-based approaches from mind-body m

Sponsors

Robert Bosch Gesellschaft für Medizinische Forschung mbH
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Breast cancer patients in a curative situation Initial diagnosis no more than 5 years ago Stage 1–3 No triple-negative breast cancer No distant metastasis (stage IV) Completed oncological treatments (chemotherapy, radiation therapy, and other active forms of therapy) – exception: anti-hormonal therapy Signed consent

Exclusion criteria

Exclusion criteria: Age < 18 years Male gender Current oncological treatments (chemotherapy, radiotherapy, and other active forms of therapy) Triple-negative breast cancer Distant metastasis of breast cancer Stage 4 breast cancer Initial diagnosis more than 5 years ago Recurrence of breastcancer Unwillingness to store and share personal medical data as part of the protocol No signed consent Current participation in another mind-body medicine program or a comparable program Insufficient knowledge of German A mental state that, in the opinion of the investigator, does not allow the patient to participate in the study Pregnancy

Design outcomes

Primary

MeasureTime frame
The effects of the mind-body medicine program on health-related lifestyle behaviors using the FANTASTIC lifestyle questionnaire (German version). The questionnaire is administered at each data collection point (T1, T2, T3). Data is collected using the RedCap electronic data capture system, with paper-pencil questionnaires available as a backup.

Secondary

MeasureTime frame
Effect of the mind-body medicine program on other parameters, such as • Health-related quality of life (FACT-B) • Subjective stress perception (PSS-10) • Fatigue (FACIT-F) • Sleep quality (PSQI) • Physical activity (IPAQ-SF) • Eating habits (MEDAS) • Anxiety and depression (HADS) • Mindfulness (MAAS) • Self-compassion (SCS) • Adverse events

Countries

Germany

Contacts

Public ContactMarcela Winkler

Robert Bosch Krankenhaus

marcela.winkler@rbk.de+49 711 8101 2073

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026