Evaluation of the Medidux™ Digital Health Application in Patients With HER2-positive Breast Cancer.

NCT05425550 | Terminated

• 1 other identifier: PRO2
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

app; PRO2; medidux; ePro; palleos; xlife science; mobile Health AG; mobile Health; medical device; palleos healthcare

Outcome Measures

Primary Outcomes (1)

• Number of Adverse events (AEs) (CTCAE severity >2) and serious AEs (SAE) within the observation period.

  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.

  From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)

Secondary Outcomes (8)

• 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)

• Serious adverse events (SAEs)

  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) respectively antibody-drug conjugate dose reduction.

  From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)

• CTX respectively antibody-drug conjugate adherence

  From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)

• Number of treatment-associated unplanned emergency consultations

  From the day of randomization until Day 84; maximum observation period is 16 weeks (112 days)

Study Arms (2)

Arm A

EXPERIMENTAL

Experimental group is using the medidux™ app

Device: medidux™ app

Arm B

NO INTERVENTION

Control group does not use the medidux™ app

Interventions

medidux™ app DEVICE

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

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 therapy (including tyrosine kinase inhibitors \[TKI\]) or an antibody-drug conjugate 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 medidux™ app must be installed prior to the start of the first treatment cycle.
• \* HER2-positive in the context of the study defined as "eligible for an approved HER2-targeted therapy," i.e., in addition to immunohistochemistry (IHC) scores of 3+ and 2+ with positive results of in-situ hybridization (ISH+), also according to new standard HER2 low (IHC 1+ and 2+ with simultaneous negative result of in-situ-hybridization (ISH-))
• \*\* Patients receiving chemotherapy in combination with HER2-targeted therapy as part of a (neo)adjuvant sequence therapy (e.g. as second part after previous EC therapy) may be included. Accordingly, the PRO2 study will not start until patients begin combination of chemotherapy and HER2-targeted therapy.

You may not qualify if:

• 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 medidux™ app or its predecessor consilium care™ before admission to the study.
• Patients with breast carcinoma who are to be treated exclusively with HER2-targeted antibody monotherapy or TKI-therapy without simultaneous chemotherapy. The sole administration of antibody-drug conjugates alone is permitted/prescribed by the SmPC.
• Simultaneous participation in an interventional clinical trial.

Sponsors & Collaborators

• Palleos Healthcare GmbH: lead
• Mobile Health AG: collaborator

Study Sites (1)

Seespital Horgen-Onkologie

Horgen, 8810, Switzerland

Location

Related Publications (23)

• Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000 May 24-31;283(20):2701-11. doi: 10.1001/jama.283.20.2701.

  PMID: 10819955 BACKGROUND

• Gnanasakthy A, DeMuro C, Clark M, Haydysch E, Ma E, Bonthapally V. Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014). J Clin Oncol. 2016 Jun 1;34(16):1928-34. doi: 10.1200/JCO.2015.63.6480. Epub 2016 Apr 11.

  PMID: 27069082 BACKGROUND

• Bennett AV, Jensen RE, Basch E. Electronic patient-reported outcome systems in oncology clinical practice. CA Cancer J Clin. 2012 Sep-Oct;62(5):337-47. doi: 10.3322/caac.21150. Epub 2012 Jul 18.

  PMID: 22811342 BACKGROUND

• Prince RM, Atenafu EG, Krzyzanowska MK. Hospitalizations During Systemic Therapy for Metastatic Lung Cancer: A Systematic Review of Real World vs Clinical Trial Outcomes. JAMA Oncol. 2015 Dec;1(9):1333-9. doi: 10.1001/jamaoncol.2015.3440.

  PMID: 26378774 BACKGROUND

• Whitney RL, Bell JF, Tancredi DJ, Romano PS, Bold RJ, Wun T, Joseph JG. Unplanned Hospitalization Among Individuals With Cancer in the Year After Diagnosis. J Oncol Pract. 2019 Jan;15(1):e20-e29. doi: 10.1200/JOP.18.00254. Epub 2018 Dec 5.

  PMID: 30523749 BACKGROUND

• Brooks GA, Abrams TA, Meyerhardt JA, Enzinger PC, Sommer K, Dalby CK, Uno H, Jacobson JO, Fuchs CS, Schrag D. Identification of potentially avoidable hospitalizations in patients with GI cancer. J Clin Oncol. 2014 Feb 20;32(6):496-503. doi: 10.1200/JCO.2013.52.4330. Epub 2014 Jan 13.

  PMID: 24419123 BACKGROUND

• McKenzie H, Hayes L, White K, Cox K, Fethney J, Boughton M, Dunn J. Chemotherapy outpatients' unplanned presentations to hospital: a retrospective study. Support Care Cancer. 2011 Jul;19(7):963-9. doi: 10.1007/s00520-010-0913-y. Epub 2010 May 25.

  PMID: 20499108 BACKGROUND

• Henry DH, Viswanathan HN, Elkin EP, Traina S, Wade S, Cella D. Symptoms and treatment burden associated with cancer treatment: results from a cross-sectional national survey in the U.S. Support Care Cancer. 2008 Jul;16(7):791-801. doi: 10.1007/s00520-007-0380-2. Epub 2008 Jan 17.

  PMID: 18204940 BACKGROUND

• Dufton PH, Drosdowsky A, Gerdtz MF, Krishnasamy M. Socio-demographic and disease related characteristics associated with unplanned emergency department visits by cancer patients: a retrospective cohort study. BMC Health Serv Res. 2019 Sep 6;19(1):647. doi: 10.1186/s12913-019-4509-z.

  PMID: 31492185 BACKGROUND

• Egbring M, Far E, Roos M, Dietrich M, Brauchbar M, Kullak-Ublick GA, Trojan A. A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. J Med Internet Res. 2016 Sep 6;18(9):e238. doi: 10.2196/jmir.6414.

  PMID: 27601354 BACKGROUND

• Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.

  PMID: 26644527 BACKGROUND

• Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.

  PMID: 28586821 BACKGROUND

• Trojan A, Huber U, Brauchbar M, Petrausch U. Consilium Smartphone App for Real-World Electronically Captured Patient-Reported Outcome Monitoring in Cancer Patients Undergoing anti-PD-L1-Directed Treatment. Case Rep Oncol. 2020 May 12;13(2):491-496. doi: 10.1159/000507345. eCollection 2020 May-Aug.

  PMID: 32518544 BACKGROUND

• Pircher M, Winder T, Trojan A. Response to Vemurafenib in Metastatic Triple-Negative Breast Cancer Harbouring a BRAF V600E Mutation: A Case Report and Electronically Captured Patient-Reported Outcome. Case Rep Oncol. 2021 Mar 29;14(1):616-621. doi: 10.1159/000513905. eCollection 2021 Jan-Apr.

  PMID: 33976643 BACKGROUND

• Schmalz O, Jacob C, Ammann J, Liss B, Iivanainen S, Kammermann M, Koivunen J, Klein A, Popescu RA. Digital Monitoring and Management of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Treated With Cancer Immunotherapy and Its Impact on Quality of Clinical Care: Interview and Survey Study Among Health Care Professionals and Patients. J Med Internet Res. 2020 Dec 21;22(12):e18655. doi: 10.2196/18655.

  PMID: 33346738 BACKGROUND

• Trojan A, Battig B, Mannhart M, Seifert B, Brauchbar MN, Egbring M. Effect of Collaborative Review of Electronic Patient-Reported Outcomes for Shared Reporting in Breast Cancer Patients: Descriptive Comparative Study. JMIR Cancer. 2021 Mar 17;7(1):e26950. doi: 10.2196/26950.

  PMID: 33729162 BACKGROUND

• Trojan A, Leuthold N, Thomssen C, Rody A, Winder T, Jakob A, Egger C, Held U, Jackisch C. The Effect of Collaborative Reviews of Electronic Patient-Reported Outcomes on the Congruence of Patient- and Clinician-Reported Toxicity in Cancer Patients Receiving Systemic Therapy: Prospective, Multicenter, Observational Clinical Trial. J Med Internet Res. 2021 Aug 5;23(8):e29271. doi: 10.2196/29271.

  PMID: 34383675 BACKGROUND

• Carpenter JR, Roger JH, Kenward MG. Analysis of longitudinal trials with protocol deviation: a framework for relevant, accessible assumptions, and inference via multiple imputation. J Biopharm Stat. 2013;23(6):1352-71. doi: 10.1080/10543406.2013.834911.

  PMID: 24138436 BACKGROUND

• Hsieh FY, Bloch DA, Larsen MD. A simple method of sample size calculation for linear and logistic regression. Stat Med. 1998 Jul 30;17(14):1623-34. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-s.

  PMID: 9699234 BACKGROUND

• Maansson R, Radley D, Jiang Q, Beeslaar J, Patterson S, Absalon J, Perez J. Modeling excess zeroes in an integrated analysis of vaccine safety. Hum Vaccin Immunother. 2018 Jun 3;14(6):1530-1533. doi: 10.1080/21645515.2018.1433972. Epub 2018 Feb 23.

  PMID: 29393713 BACKGROUND

• Zhu H, Lakkis H. Sample size calculation for comparing two negative binomial rates. Stat Med. 2014 Feb 10;33(3):376-87. doi: 10.1002/sim.5947. Epub 2013 Aug 23.

  PMID: 24038204 BACKGROUND

• van Buuren S, Groothuis-Oudshoorn K. mice: Multivariate Imputation by Chained Equations in R. Journal of Statistical Software 2011, 45(3), 1-67. doi: 10.18637/jss.v045.i03

  BACKGROUND

• Trojan A, Kuhne C, Kiessling M, Schumacher J, Drose S, Singer C, Jackisch C, Thomssen C, Kullak-Ublick GA. Impact of Electronic Patient-Reported Outcomes on Unplanned Consultations and Hospitalizations in Patients With Cancer Undergoing Systemic Therapy: Results of a Patient-Reported Outcome Study Compared With Matched Retrospective Data. JMIR Form Res. 2024 May 6;8:e55917. doi: 10.2196/55917.

  PMID: 38710048 DERIVED

Related Links

• National Cancer Institute. Common Terminology Criteria for Adverse Events v.4.0 (CTCAE). Accessed March 8th, 2017.

MeSH Terms

Conditions

Breast Neoplasms; Alzheimer Disease

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Andreas Trojan, Prof. Dr.

  Seespital Horgen-Onkologie

  PRINCIPAL INVESTIGATOR

• Peter Fasching, Prof. Dr.

  Universitätsklinikum Erlangen; Frauenklinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 21, 2022
• Study Start: August 29, 2022
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)