Clinical trial · Interventional
Participatory Research for Fine-tuning of a 2.0 System to Optimise Home Management of Oral Cancer Therapies.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective testing-validation, interventional, non-pharmacological study on a new app for oral anticancer therapy management. A total of 80 patients will be considered: 20 evaluable patients in the training step; 60 patients in the validation step. In the training step will be considered evaluable the patients with: at least 6 weeks of treatment; visit at 6 weeks after the start of treatment performed and questionnaires self-administered. Patients will be visited every 6 weeks. In the training step, patients will remain under observation for a minimum of 6 weeks, until change of therapy (due to progression of disease, unacceptable toxicity, death, discontinuation) or for a maximum of 12 weeks. Patients enrolled in the validation step will remain under observation until change of therapy (due to progression of disease, unacceptable toxicity, death, discontinuation) or for a maximum of 24 weeks. The objective of this study is to assess the capability of a newly developed interactive health care application to support patients and health professionals in the shared management of oral anticancer therapies, improving adherence, preventing complications at home, toxicities, improper treatment reductions or interruptions, emergency accesses and to assess the system usability and acceptability by patients and health professionals, integration in the hospital workflow, monitoring over time patient perceived levels of quality of care, quality of life, social support, anxiety, and self-care capability.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Oral Drug Administration | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TreC-Onco | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cancer patients undergoing oral therapy
- description
- At the time of therapy prescription, patients candidate for oral therapy with capecitabine or sunitinib will be provided with informations on the side-effects of therapy and on the use and functions of the mobile diary app TreC-Onco. Patients are required to manually insert data into the mobile diary app at least once a day. Patients will be visited every 6 weeks. During the visit, the clinician will compare adherence and toxicity data entered into the mobile diary app with those directly reported by the patient and by drug accountability.
- interventionNames
- Device: TreC-Onco
Primary outcomes (2)
- measure
- Drug accountability comparison
- timeFrame
- 3 years
- description
- the number of pills counted by the system (self-reported by the patient at home) will be compared with that counted by the physician as residual pills returned by the patient at the hospital visit. A difference in the number of pills within +/- 10% will be considered acceptable.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG-Performance Status (PS) less or equal to 1; * life expectancy \> 12 weeks; * candidate for treatment with capecitabine or sunitinib as monotherapy (adjuvant and advanced settings allowed); * clear understanding of the Italian language; * subjects who are, in the opinion of the Investigator, able to understand this study, to cooperate with the study procedures and able to manage mobile devices after basic training course held at baseline; * written informed consent Exclusion Criteria: * Patients receiving also intravenous anticancer treatment
References
Publications (2)
- DERIVEDPassardi A, Foca F, Caffo O, Tondini CA, Zambelli A, Vespignani R, Bartolini G, Sullo FG, Andreis D, Dianti M, Eccher C, Piras EM, Forti S. A Remote Monitoring System to Optimize the Home Management of Oral Anticancer Therapies (ONCO-TreC): Prospective Training-Validation Trial. J Med Internet Res. 2022 Jan 26;24(1):e27349. doi: 10.2196/27349. PMID 35080505
- DERIVEDPassardi A, Rizzo M, Maines F, Tondini C, Zambelli A, Vespignani R, Andreis D, Massa I, Dianti M, Forti S, Piras EM, Eccher C. Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study. BMJ Open. 2017 May 29;7(5):e014617. doi: 10.1136/bmjopen-2016-014617. PMID 28554917