PRO2: Evaluation of the Consilium Care™ Digital Health Application in Patients With HER2-positive Breast Cancer During Chemotherapy in Combination With HER2-targeted Antibody Therapy.

Sponsor

Palleos Healthcare GmbH (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05425550

Collaborator

mobile Health AG (Other)

585

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Multicenter, prospective, randomised and controlled study to evaluate the consilium care™ app during an observation period of 12 weeks (maximum 16 weeks in case of shifts in the initially planned therapy).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: consilium care™ app	N/A

Detailed Description

The PRO2 study is being conducted by palleos healthcare GmbH, the sponsor of the study, with the participation of an expected 585 patients at 40 study sites in Germany and 10 study sites in the German-speaking part of Switzerland with the aim of investigating the medical benefit of the smartphone application consilium care™ (app) with regard to the occurrence of side effects in breast cancer therapy. Furthermore, the potential impact on the application of the chemotherapy, the number of unplanned doctor visits, as well as hospitalizations and how often the app is used will be investigated.

The app was developed by mobile Health AG and is intended to accompany therapy. It is an approved CE-marked medical device that will be used in the study within the intended purpose. Study participants can use the app to document symptoms and well-being, as well as vital signs (e.g., blood pressure), and complete a test that can be used to assess mental performance. The entries can be viewed by the study physician through the consilium care™ web application. The study participants can refer to the entries during the treatment visit to explain the course of therapy and perceived symptoms. As part of the study, use of the app will be compared to the normal treatment routine (without the app). A randomization process will determine whether study participants receive the app. The probability of receiving the app is 50%. If study participants receive the app, it can be used after installation on the personal smartphone. The approximately 12- to a maximum of 16-week observation period begins with the regular breast cancer therapy. The specific treatment of the breast cancer is not interfered with during the study, i.e. the administration of the therapy itself is carried out in the same way as it would be without the app.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

585 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Evaluation of the Consilium Care™ Digital Health Application in Patients With HER2-positive Breast Cancer During Chemotherapy in Combination With HER2-targeted Antibody Therapy: a Multicenter Randomized Controlled Trial.

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A Experimental group is using the consilium care™ app	Device: consilium care™ app Use of the regular consilium care™ application for 12 (maximum 16) weeks
No Intervention: Arm B

Arm

Intervention/Treatment

Experimental: Arm A

Experimental group is using the consilium care™ app

Device: consilium care™ app

Use of the regular consilium care™ application for 12 (maximum 16) weeks

No Intervention: Arm B

Outcome Measures

Primary Outcome Measures

Number of Adverse events (AEs) (CTCAE severity >2) and serious AEs (SAE) within the observation period. [From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)]
As the primary endpoint, the occurrence of adverse events, either of type SAE or of type AE with CTCAE severity >2, with a start date within the observation period will be measured for each patient. In the following, these events are referenced as high-grade AEs (HAE). The parameters included in the primary endpoint analysis are recorded by the investigator during regular study visits within 12 weeks. The observation period can, however, be extended to the period required for the completion of the initially planned therapy due to shifts in therapy; the maximum observation period is limited to 16 weeks. Adverse events are mapped to the hierarchy and thesaurus terms of the Medical Dictionary for Regulatory Activities (MedDRA, latest version). Severity will be determined according to NCI CTCAE v5.0. In addition to the assessment by the investigators and the medical monitor, the HAEs will be assessed by a blinded medical expert (Adjudicator) and a classification is made independently.

Secondary Outcome Measures

Adverse events (AE) occurring in the observation period recorded and assessed by the investigator during the scheduled study visits. [From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)]
Adverse events (AE) occurring in the observation period recorded and assessed by the investigator during the scheduled study visits. Events classified as "hair loss" (alopecia) are excluded from the analysis as they cannot be influenced a priori by the consilium care™ app but may be subject to a technological center bias due to the availability of "cold caps", which cannot be controlled within the scope of the study. Adverse events are mapped to hierarchy and thesaurus terms of the Medical Dictionary for Regulatory Activities (MedDRA, latest version). Severity is determined according to NCI CTCAE v5.0.
Serious adverse events (SAEs) [From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)]
Serious adverse events (SAEs), defined as a subset of the adverse events defined under Outcome 2 that are classified as "serious".
Number of patients with at least one documented chemotherapy (CTX) dose reduction. [From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)]
Number of patients with at least one documented chemotherapy (CTX) dose reduction.
CTX adherence [From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)]
CTX adherence defined as the percentage of cumulative chemotherapy dose actually received relative to the planned cumulative dose.
Number of treatment-associated unplanned emergency consultations [From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)]
Unplanned emergency consultations are defined as emergency-related consultations outside of planned treatment or follow-up visits to the treatment center or the investigator, as well as unplanned visits to other physicians or emergency services.
Number of hospitalisations [From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)]
Number of hospitalisations defined as inpatient admission at the center or at another medical facility because of an (S)AE
Number and severity of symptoms recorded by consilium care™ in the experimental arm. [From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)]
Number and severity of symptoms recorded by consilium care™ (for ePRO modified NCI CTCAE 4.0 subset of 106 items for cancer) in the experimental arm. ePRO symptoms can be continuously documented via the app by the patient.
Adherence [From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)]
Adherence defined for the experimental arm as the percentage of days in the observation period on which any form of use of the consilium care™ app took place.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with signed informed consent.
Female and male patients, age at diagnosis 18 years and older.
Patients with HER2-positive breast carcinoma (confirmed by a local pathologist).
Patients with breast carcinoma with positive or negative hormone receptor status.
Patients prior to initiation of neoadjuvant, adjuvant or palliative chemotherapy in combination with HER2-targeted antibody therapy.
ECOG performance Status ≤ 1.
Sufficient command of the German language as assessed by the investigator.
Presence of a personal smartphone with iOS or Android system. The operating system must be updated to the latest, second or third most recent major version and the consilium care™ app must be installed prior to the start of the first treatment cycle.

Exclusion Criteria:

Patients for whom it is questionable whether they will follow the study protocol, e.g., due to psychological problems or their private life situation.
Patients with insufficient knowledge about the use of smartphones.
Patients at the start of therapy with an ECOG performance status ≥ 2.
Patients who have already used the consilium care™ app before admission to the study.
Patients with breast carcinoma who are to be treated exclusively with HER2-targeted antibody monotherapy without simultaneous chemotherapy.
Simultaneous participation in an interventional clinical trial.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Palleos Healthcare GmbH
mobile Health AG

Investigators

Principal Investigator: Andreas Trojan, Prof. Dr. med., Onko Zentrum Zürich
Principal Investigator: Peter Fasching, Prof. Dr. med., Universitätsklinikum Erlangen; Frauenklinik