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SYMPHA

  • In preparation

BOOG 2024-01

General Information

BOOG number

BOOG 2024-01

Nickname

SYMPHA

Status

  • In preparation
Date: 15/07/2024

Participating parties / group

IKNL, UT

Full title

Early detection of symptoms using digital patient reported symptoms monitoring and a Fitbit to optimize care in metastatic breast cancer.

Indication

  • Data registration, Advanced/Metastatic

Subindication

mBC: TNBC, HR+Her2-, Her2+ (first line)

Description

Symptom monitoring in metastatic breast cancer

Target sample size

Run-in phase: appr. 70, Randomization phase: 384

Contact

Sponsor

IKNL

Principal Investigator(s)

Dr. A. Jager (EMC)
Dr. C. van den Hurk (IKNL)
Dr. C.H.C. Drossaert (UT)
Dr. ir. M. Mulder (EMC)

Study manager

Clinical Study Manager: Susan van den Berg (BOOG SC)
Project assistant: Suzanne Jager (BOOG SC)

info@boogstudycenter.nl

Study coordinator

Project leader / Principal investigator:
Prof. Dr. Sabine Siesling (IKNL / UT)

Coordinating investigators:
Lois Folkert, MSc (IKNL / UT)
Dr. Jolanda van Hoeve (IKNL)

sympha@iknl.nl

Central datamanagement and randomization

IKNL / Castor EDC

Monitoring

IKNL

Local datamanagement

Not applicable

Funding

KWF

Design

Basket trial: three separate clinical prospective open label 1:1 randomized clinical trials (RCTs) within the three different mBC subtypes (TNBC, HR+Her2- or Her2+) preceded by a run-in phase.

Objectives

Primary objective

To determine the effect of real-time PRS monitoring on HRQoL (summary score) in patients with mBC who start first-line chemo(immune)therapy .

Secondary objectives

  1. To explore the role of a Fitbit in objectifying, early detection and prediction of symptoms.
  2. To determine the effect of real-time PRS monitoring on:
    • HRQoL physical functioning domain (next to the summary score this domain has most prognostic value [20]
    • Severity, number and course of PRS
    • Treatment switches, time to next treatment (TTNT) and treatment intensity
    • Anit-tumor therapy adherence of patients with oral medication
    • Healthcare resource use during the trial participation period including (emergency) hospital admissions, (diagnostic) procedures, symptom management (incl. co-medication) and appointments with healthcare professionals outside the hospital.
    • Cost-effectiveness of real-time PRS monitoring compared to standard of care
    • Long term HRQoL (max. three years) and time to deterioration
    • Overall survival
    • Patient empowerment
  3. To evaluate patients’ experiences with and usage of the PRS-app and a Fitbit.
  4. To evaluate healthcare professionals’ experiences, usage and facilitators and barriers for implementation of PRS-apps.

Endpoints

Primary endpoint

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, six months.

Secondary endpoints

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.

Eligibility Criteria

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.

 

For the Fitbit a mobile phone with internet and Bluetooth is required. Patients who are not able or not willing to wear the Fitbit can still participate in this trial and will only use the app.

 

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;

Regulatory Information

EC approval

Submitted

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