This study aims to determine the effect of real-time symptom monitoring on HRQoL in patients with mBC who start first-line chemo(immune)therapy. Further objectives include analyzing the effect of PRS monitoring on physical functioning, the severity…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main 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 outcome
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.
Background summary
New pharmaco-therapeutic options for metastatic breast cancer (mBC) improve
prognosis only slightly but can cause severe toxicities and symptoms affecting
health-related quality of life (HRQoL). Early identification of
Patient-Reported Symptoms (PRS), resulting from treatment toxicities or disease
progression may preserve HRQoL, improve adherence of the anti-tumor therapy or
might lead to an earlier switch to second-line chemo(immune)therapy with less
toxicity which may improve cost-effectiveness.
Study objective
This study aims to determine the effect of real-time symptom monitoring on
HRQoL in patients with mBC who start first-line chemo(immune)therapy. Further
objectives include analyzing the effect of PRS monitoring on physical
functioning, the severity of symptoms, treatment patterns, therapy adherence,
healthcare resource use, cost-effectiveness, long-term HRQoL, overall survival
and patient empowerment. The main secondary objective is to explore the role of
a Fitbit in objectifying, early detection and prediction of symptoms.
Additionally, the usage, experiences, facilitators and barriers for the
implementation of PRS-apps and a Fitbit will be evaluated.
Study design
We will perform 3 separate randomized clinical trials (RCTs) within the 3
different mBC subtypes (TNBC, HR+Her2- or Her2+) preceded by a run-in phase.
Intervention
Patients allocated to the intervention arm will use a PRS-app to report their
symptoms. Patients receive an alert to contact the healthcare professional
(HCP) 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.
Study burden and risks
There are no medical risks associated with the use of the PRS-app and the
Fitbit. All patients will receive systemic therapy, which is standard care. The
intervention arm will use the PRS-app in addition to standard of care
monitoring. The PRS-app gives patients the opportunity to enhance their own
disease management. Early recognition of symptoms may lead to more timely
clinical intervention.
Rijnkade 5
Utrecht 3511 LC
NL
Rijnkade 5
Utrecht 3511 LC
NL
Listed location countries
Age
Inclusion criteria
Women diagnosed with mBC (either synchronous or metachronous) starting with
first line systematic chemo(immune)therapy for mBC. This can be preceded by
endocrine treatments in the mBC setting;
Age >=18 years at diagnosis;
Ability to read and understand the Dutch, Turkish or Arabic language;
WHO PS <=1;
Access to internet via a mobile phone, tablet, laptop or computer.
Exclusion criteria
Participation in a trial with an investigational product (because more frequent
and structured symptom reporting is performed in these studies);
Already participating in a treatment study that includes structured symptom
reporting.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87687.100.24 |