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
Phase 4
- Conditions
- mamma carcinomaC50Malignant neoplasm of breast
- Registration Number
- DRKS00028699
- Lead Sponsor
- PINK gegen Brustkrebs GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 434
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
Estimated survival < 3 months
Use of another app to accompany cancer therapy or aftercare
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PHQ-9 sum score to the following points of time:<br>- Baseline (zum Rekrutierungszeitpunkt)<br>- T1 (after 4 weeks)<br>- T2 (after 8 weeks)<br>- T3 (after 12 weeks)<br>- T4 (longtime followup after 6 months)<br>- T5 (longtime followup after12 months)
- Secondary Outcome Measures
Name Time Method health-related quality of life, physical activity, resilience, fatigue:<br>- Baseline (at the time of recruitment)<br>- T1 (after 4 weeks)<br>- T2 (after 8 weeks)<br>- T3 (after 12 weeks)<br>- T4 (longtime followup after 6 months)<br>- T5 (longtime followup after 12 months)<br><br>health literacy:<br>- Baseline (at the time of recruitment)<br>- T3 (after 12 weeks)<br> <br>BMI:<br>- Baseline (at the time of recruitment)<br>- T2 (after 8 weeks)<br>- T3 (after 12 weeks)<br>- T4 (longtime followup after 6 months)<br>- T5 (longtime followup after 12 months)<br><br>economic endpoints<br>- Baseline (at the time of recruitment)<br>- T3 (after 12 weeks)<br>- T5 (longtime followup after 12 months)