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Randomized controlled pilot study of the clinical efficacy of the Mika App

Randomized controlled pilot study of the clinical efficacy of the Mika App - MIKA

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00023791
Enrollment
70
Registered
2022-02-24
Start date
2020-06-03
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C51-C58

Interventions

Group 1: Intervention group receives Mika over a period of 12 weeks Group 2: Control group receives treatment as ususal

Sponsors

Fosanis GmbH
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: possession of a smartphone - diagnosed carcinoma (ovary, endometrium, cervix) - German speaking

Exclusion criteria

Exclusion criteria: - no secured diagnosis of carcinoma - not able to give informed consent - diagnosis more than 5 years ago -lack of smartphone or tablet skills

Design outcomes

Primary

MeasureTime frame
Group comparison of change in psychological distress, measured by the PHQ-9, from baseline (week 0) to week 12 between.

Secondary

MeasureTime frame
Group comparison of change in fatigue symptomatology (measured with EORTC-QLQ-C30) and health literacy (measured with HLS-EU-Q16) from baseline to week 12.

Countries

Germany

Contacts

Public ContactAyline Maier

Fosanis GmbH

AylineM@web.de+491784114659

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026