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

Phase 4

• Conditions: C50; Malignant neoplasm of breast

• Registration Number: DRKS00025811
• Lead Sponsor: Brustzentrum LMU München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the PHQ-9 total score after 12 weeks

Secondary Outcome Measures

Name	Time	Method
EORTC-QLQ-C30<br>PAM-13<br>EHEALS<br>IPAQ SF<br>BMI<br><br>(all after 12 weeks with 4 measuring points each - baseline, T1 after 4 weeks, T2 after 8 weeks, T3 after 12 weeks)