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

Not Applicable

• Conditions: C50; Malignant neoplasm of breast

• Registration Number: DRKS00031243
• Lead Sponsor: PINK! gegen Brustkrebs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 194

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

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HADS summ score<br>at 2,4,6 and 8 weeks (primary endpoint)<br>ar 3, 6 and 12 months (Follow-up)

Secondary Outcome Measures

Name	Time	Method
Fatigue (BFI) <br><br>RS-13 (Resiliece) <br><br>PA-F (fear of recurrence) <br><br>VAS-Skala aus EQ-5D (QoL) <br><br>HADS-A (Anxiety) <br><br>HADS-D (Depression)