Method validation (pilot study) on the effectiveness of PINK! Coaching app for digital therapy and follow-up care for patients with breast cancer - a prospective, randomized-controlled feasibility study

Method validation (pilot study) on the effectiveness of PINK! Coaching app for digital therapy and follow-up care for patients with breast cancer - a prospective, randomized-controlled feasibility study - PINK!

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025811

Enrollment

Registered

2021-10-06

Start date

2021-08-18

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: PINK! App Usage over 12 weeks during therapy or in aftercare Group 2: Control: Standard of care (no App usage)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of a malignant tumor of the breast,> 18 years old, smartphone possession, German-speaking, (1) during acute therapy or (2) in follow-up care

Exclusion criteria

Exclusion criteria: severe psychological stress (PHQ-9 total score at baseline> 20), severe cognitive impairment

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the PHQ-9 total score after 12 weeks	—

Secondary

Measure	Time frame
EORTC-QLQ-C30 PAM-13 EHEALS IPAQ SF BMI (all after 12 weeks with 4 measuring points each - baseline, T1 after 4 weeks, T2 after 8 weeks, T3 after 12 weeks)	—

Countries

Germany

Contacts

Public ContactJosefine Wolff

Frauenklinik Brustzentrum LMU München

josefine.wolff1993@gmail.com0170 2231831

Outcome results

None listed

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