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Mindfulness-Based Stress Reduction (MBSR) for the Reduction of Anxiety and Depressive Symptoms in Patients with Advanced Palliative Oncological Disease – A Randomized Controlled Pilot Study

Mindfulness-Based Stress Reduction (MBSR) for the Reduction of Anxiety and Depressive Symptoms in Patients with Advanced Palliative Oncological Disease – A Randomized Controlled Pilot Study - CALMNESS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038112
Enrollment
108
Registered
2025-10-13
Start date
2025-10-07
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

palliative-stage oncological disease

Interventions

Group 1: Abbreviated One-on-One Mindfulness Intervention (based on MBSR) Group 2: Standard of care

Sponsors

Universitätsklinikum Hamburg - Eppendorf
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (Hematologic) oncological patients with advanced palliative disease (at least documented progression after first-line therapy) HADS-A and HADS-D = 8 Expected survival of at least 3 months = 18 years of age Available access to the Internet and a PC, laptop, smartphone, or tablet Understanding of the German language, both written and spoken Willingness to participate in an MBSR study / provision of written informed consent

Exclusion criteria

Exclusion criteria: Advanced non-oncological chronic diseases: Child C liver cirrhosis, end-stage renal disease, heart failure NYHA III or IV Previous participation in similar interventions or established active mindfulness practice Cognitive or language barriers that would interfere with the execution of the interventions

Design outcomes

Primary

MeasureTime frame
HADS-D (Hospital Anxiety and Depression Scale), measured before the start of the intervention (study enrollment), immediately after the intervention (4 weeks after study enrollment), and 4 weeks after completion of the intervention (8 weeks after study enrollment).

Secondary

MeasureTime frame
• EORTC QLQ-C15 PAL • Brief Fatigue Inventory (BFI) • Pittsburgh Sleep Depriviation Scale (PSQI) • Demoralisation Scale • Spiritual Needs Questionaire (SpNQ) • Ehrfurcht-Dankbarkeit-Fragebogen (Awe and Gratitude (GrAw-7))

Countries

Germany

Contacts

Public ContactAlina Busch

Universitätsklinikum Hamburg - Eppendorf

al.busch@uke.de+ 494074100

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026