Clinical trial · Observational
Efficacy of the "Consilium" Smartphone App for Detecting Symptoms and Treatment Side Effects in Cancer Patients
Efficacy of the "Consilium" Smartphone App for Detecting Symptoms and Treatment Side Effects in Cancer Patients Depending on Form of Medication Application, Age and Outpatient Characteristics: Observational Study
NCT03578731CI-TRIAL-00056248APP-2terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Mainly due to insufficient recruitment
Summary
Brief summary (as posted)
The study investigates the influence of the use of a Smartphone App, on changes in general well-being and the occurrence of symptoms during a tumor therapy. With this documentation, medical professionals should be enabled to judge the influence of symptoms on quality of life during different time periods, between planed visits on site.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| eHealth | — | UNRESOLVED | — |
| Telemedicine | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| app | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Consilium-APP
- description
- Patients with oncological, medical treatment for breast cancer, colon cancer, prostate cancer, lung cancer or hematological malignancies.
- interventionNames
- Device: app
Primary outcomes (1)
- measure
- Level of agreement
- timeFrame
- 12 weeks of treatment
- description
- Level of agreement κ with respect to categories of common toxicity criteria (ECOG/CTCAE) categories between ePRO recording and the treating physician at time of consultation
Secondary outcomes (6)
- measure
- ePRO and therapy side effects
- timeFrame
- 12 weeks of treatment
- description
- Assessment of the number, characteristics and intensity of electronically reported symptoms and therapy side effects during the first three months of therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed Informed Consent Form * Women or men aged ≥ 18 years * Patients with breast, colon, prostate, lung cancer or hemat. malignancies * Initiation or change of therapy for the types of cancer mentioned above * German speaking * Personal smartphone with iOS or Android system Exclusion Criteria: * Patients whose compliance must be questioned, e.g. due to a psychological disorders or private life situation * Patients with insufficient knowledge of smartphone use.
References
Publications (4)
- DERIVEDTrojan 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
- DERIVEDTrojan A, Roth S, Atassi Z, Kiessling M, Zenhaeusern R, Kadvany Y, Schumacher J, Kullak-Ublick GA, Aapro M, Eniu A. Comparison of the Real-World Reporting of Symptoms and Well-Being for the HER2-Directed Trastuzumab Biosimilar Ogivri With Registry Data for Herceptin in the Treatment of Breast Cancer: Prospective Observational Study (OGIPRO) of Electronic Patient-Reported Outcomes. JMIR Cancer. 2024 Apr 4;10:e54178. doi: 10.2196/54178. PMID 38573759
- DERIVEDTrojan 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
- DERIVEDTrojan 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