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

Phase 3

• Conditions: C00-C97; Malignant neoplasms

• Registration Number: DRKS00026038
• Lead Sponsor: Medizinische Psychologie und Medizinische Soziologie Uniklinik Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-06
• Study Completion: 2022-03-04
• Results First Posted: 2024-02-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 248

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distress / psychological stress (distress thermometer):<br>Assessed at t0 (baseline), t1 (2 weeks), t2 (6 weeks), t3 (12 weeks).

Secondary Outcome Measures

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