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Evaluation of medical benefits and positive effects of the certified medical product PINK! Coach in a multi-centre, randomized controlled clinical study with breast cancer patients

Evaluation of medical benefits and positive effects of the certified medical product PINK! Coach in a multi-centre, randomized controlled clinical study with breast cancer patients - PINK! Coach

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028699
Enrollment
422
Registered
2022-08-29
Start date
2022-09-23
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

mamma carcinoma C50

Interventions

Group 1: using PINK! Coach: Intervention group receives the App for 12 months. After reaching the primary outcome after 3 months, the control group receives the App, which means 9 months of usage.

Sponsors

PINK gegen Brustkrebs GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: age > 18 years German speaking Histologically proven breast cancer (all stages, TNM classifications, therapies) Diagnosis of the initial disease, recurrence, metastasis within the last 6 months In initial therapy (at least 6 weeks left at the time of recruitment) or discharge for aftercare at the time of recruitment owning a smartphone willingness to use PINK! Coach regularly existence of an e-mail address

Exclusion criteria

Exclusion criteria: Estimated survival < 3 months Use of another app to accompany cancer therapy or aftercare

Design outcomes

Secondary

MeasureTime frame
health-related quality of life, physical activity, resilience, fatigue: - Baseline (at the time of recruitment) - T1 (after 4 weeks) - T2 (after 8 weeks) - T3 (after 12 weeks) - T4 (longtime followup after 6 months) - T5 (longtime followup after 12 months) health literacy: - Baseline (at the time of recruitment) - T3 (after 12 weeks) BMI: - Baseline (at the time of recruitment) - T2 (after 8 weeks) - T3 (after 12 weeks) - T4 (longtime followup after 6 months) - T5 (longtime followup after 12 months) economic endpoints - Baseline (at the time of recruitment) - T3 (after 12 weeks) - T5 (longtime followup after 12 months)

Primary

MeasureTime frame
PHQ-9 sum score to the following points of time: - Baseline (zum Rekrutierungszeitpunkt) - T1 (after 4 weeks) - T2 (after 8 weeks) - T3 (after 12 weeks) - T4 (longtime followup after 6 months) - T5 (longtime followup after12 months)

Countries

Germany

Contacts

Public ContactSvenja Seidel

Frauenklinik Brustzentrum LMU München

svenja.seidel@med.uni-muenchen.de+49 089/4400-77994

Outcome results

None listed

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