metastatic breast cancer metastatic breast cancer
Conditions
Interventions
Patients allocated to the intervention arm will use a PRS-app to report their 
symptoms. Patients receive an alert to contact the hospital
when the severity of symptoms exceeds a clinically relevant threshold. 
The control arm will notify symptoms as usual in standard care, i.e. without 
using a PRS-app. All patients will fill in HRQoL questionnaires and will be 
asked to wear a Fitbit (optionally).
Sponsors
IKNL
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women diagnosed with mBC (either synchronous or metachronous);Who will start second- or third-line chemo(immune)therapy for mBC; and has undergone first-line chemo(immune)therapy for mBCregardless of prior endocrine therapy lines for mBC Age =18 years;Ability to read and understand the Dutch, Turkish or Arabic language;WHO Performance Status (PS) =2; Life expectancy =3 months;Access to internet via a mobile phone, tablet, laptop or computer.
Exclusion criteria
Exclusion criteria: Oligometastatic disease (because these patients receive treatment regimens with curative intent);Participation in a trial with an investigational product (because more frequent and structured symptom reporting is performed in these studies);Already participating in a study or project that includes structured symptom reporting.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the difference of HRQoL between the control and intervention arms on the mean difference between T0 (start of the first line systemic chemo(immune)therapy for mBC) and the mean HRQoL during the first line of therapy until first switch of therapy or, in case of no switch, 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include differences between the control and intervention arms in the severity of symptoms, treatment patterns, therapy adherence, healthcare resource use, cost-effectiveness, long-term HRQoL, overall survival and patient empowerment. In addition, we strive for a first step towards a trained and (internally) validated model for early detection and prediction of symptoms through Fitbit data. | — |
Countries
Netherlands
Contacts
Public ContactS. Siesling
IKNL
Outcome results
None listed