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SMILER - Smart and Interactive Home Based Health Care Project – A Digital Healthcare Feasibility Pilot Study Including the d.H2C2 Initiative

SMILER - Smart and Interactive Home Based Health Care Project – A Digital Healthcare Feasibility Pilot Study Including the d.H2C2 Initiative

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00035848
Enrollment
80
Registered
2025-06-06
Start date
2021-10-13
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

breast cancer C50

Interventions

Group 1: Patients receive a digital home health care system for remote monitoring of side effects under CDK4/6 inhibitor therapy

Sponsors

Frauenklinik des Uniklinikums Erlangen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to No maximum

Inclusion criteria

Inclusion criteria: CDK4/6 cohort: - Indication for treatment with a CDK4/6 inhibitor as part of routine clinical practice - Treatment with a CDK4/6 inhibitor independent of the therapy cycle - Signed consent as part of the study Control cohort - Diagnosed cancer within the last five years - Signed consent within the scope of the study

Exclusion criteria

Exclusion criteria: - Pacemaker or implantable cardioverter defibrillator (ICD) - Serious blood coagulation disorders that require regular coagulation checks - Abnormalities in the last known ECG - Patients who could avoid observation as part of the study due to other comorbidities not mentioned above

Design outcomes

Primary

MeasureTime frame
Feasibility of measuring WBCs and transmitting data from home (home-based).

Secondary

MeasureTime frame
Feasibility of ECG measurements and data transmission from home.

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026