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Prospective Randomized Group Controlled Study of Clinical Efficacy and Safety of the CE marked Mika App

Prospective Randomized Group Controlled Study of Clinical Efficacy and Safety of the CE marked Mika App - OnkoDigitrial II

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00026038
Enrollment
250
Registered
2021-10-06
Start date
2021-10-04
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

C00-C97

Interventions

Group 1: intervention group: At the beginning of the study, the IG will receive access to the psycho-oncological app Mika and a telephone introduction. Over the study period of 12 weeks, a total of 4

Sponsors

Medizinische Psychologie und Medizinische Soziologie Uniklinik Leipzig
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) =18 years, (2) cancer diagnosis within the last 5 years (ICD-10: C00-C97), (3) access to a smartphone/tablet, and (4) ability to provide informed consent

Exclusion criteria

Exclusion criteria: (1) insufficient German language skills, (2) inability to use a smartphone/tablet, and (3) prior use of the app

Design outcomes

Primary

MeasureTime frame
Distress / psychological stress (distress thermometer): Assessed at t0 (baseline), t1 (2 weeks), t2 (6 weeks), t3 (12 weeks).

Secondary

MeasureTime frame
Secondary: fatigue (FACIT-F), anxiety (HADSD), depression (HADSD), quality of life (CGI-I). Tertiary: fatigue (FA12), quality of life (CGI-S, SF8), adherence (structured interview), health literacy (structured interview), patient sovereignty (structured interview) All collected at t0 (baseline), t1 (2 weeks), t2 (6 weeks), t3 (12 weeks) The structured interview was developed by Prof. H.P. Zenner (University of Tübingen) and collects objective data.

Countries

Germany

Contacts

Public ContactAnja Mehnert-Theuerkauf

Medizinische Psychologie und Medizinische Soziologie, Uniklinik Leipzig

anja.mehnert@medizin.uni-leipzig.de0341 97 15463

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026