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Evaluation of medical benefits and positive effects on patient supply of the certified medical product PINK! Leben in a multi-centre, randomized controlled trial with breast cancer patients

Evaluation of medical benefits and positive effects on patient supply of the certified medical product PINK! Leben in a multi-centre, randomized controlled trial with breast cancer patients - PINK! Leben

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031243
Enrollment
194
Registered
2023-03-07
Start date
2023-07-19
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

C50

Interventions

Group 1: intervention group uses PINK! Leben course Completing the psycho-oncological online course PINK! Leben with tablet, laptop or computer. The course is subdivided into 4 modulus, that are based

Sponsors

PINK gegen Brustkrebs GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: German speaking Proof of the diagnosis of a histologically confirmed breast carcinoma willingness to accept the PINK! complete the life course Willingness to fill out online questionnaires (8 in total) Presence of an email address Presence of a laptop / computer / tablet Therapy situation: (1) still at least 8 weeks in therapy (2) OR discharge for aftercare (outpatient) (up to 6 months after the end of therapy) (3) OR upon commencement of 3 or 4 week inpatient rehabilitation

Exclusion criteria

Exclusion criteria: Planned psycho-oncological care during therapy or rehabilitation Use of another app / online course to reduce psychological stress (also PINK! Coach) Strong previous psychological stress: currently severe depression (F32.2, F32.3, F33.2, F33.3, possibly also F31.4, F31.5), acute suicidality (no ICD diagnosis, as symptom R45.8 , Z91.8)

Design outcomes

Primary

MeasureTime frame
HADS summ score at 2,4,6 and 8 weeks (primary endpoint) ar 3, 6 and 12 months (Follow-up)

Secondary

MeasureTime frame
Fatigue (BFI) RS-13 (Resiliece) PA-F (fear of recurrence) VAS-Skala aus EQ-5D (QoL) HADS-A (Anxiety) HADS-D (Depression)

Countries

Germany

Contacts

Public ContactAndreas-Claudius Hoffmann

KMG Klinikum Plau am See

a.hoffmann@kmg-kliniken.de038735 880

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026