Clinical trial · Interventional
Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology
NCT04826458CI-TRIAL-00098276completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 multicenter, interventional, non-pharmacological study on a app for oral anticancer therapy management. A total of 124 patients will be considered. Patients will be randomized 1:1 to one of the following interventions: A. electronic diary B. paper diary The primary aim of the study is to assess the effectiveness of the electronic diary in improving adherence to oral therapy treatment compared to the paper diary, in patients with solid and haematological tumors.
Conditions
Conditions (4)
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 |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Oral Drug Administration | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paper diary | Other | — | UNRESOLVED |
| TreC-Onco | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A. electronic diary (TreC-Onco)
- description
- At the baseline visit, each patient assigned to arm A will be provided with the electronic diary (installed on a smart phone or tablet), the oral medication for the first treatment cycle and the appointment for the next cycle. The patient will be instructed on how to use the electronic diary, and the user manual will also be given. This app allows patients to record parameters related to their health state (e.g. medications, blood pressure, weight, fever, side effects or other symptoms) and through the "alarm" function, it reminds the patient to take the tablets, indicating the exact dosage. In addition, the patient can also indicate the dose reduction or the omission.
- interventionNames
- Device: TreC-Onco
- type
- OTHER
- label
- B. paper diary
- description
- Patients assigned to arm B will be provided with a paper diary, oral medication for the first treatment cycle and the appointment for the next cycle. The patient will be instructed on how to use the paper diary.
- interventionNames
- Other: Paper diary
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years old (both genders) * Eastern Cooperative Oncology Group (ECOG) ≤2 * Patients with solid and haematological neoplasia (adjuvant or advanced setting) candidates to treatment with oral therapy. Exclusion Criteria: * Patients who also receive anticancer treatment intravenously, as such patients access the hospital regularly and are in closer contact with healthcare personnel. * Patients receiving experimental cancer treatment * Patients who are unable to cooperate with study procedures (in the researcher's opinion) * Patients who are candidates for oral drug treatment lasting less than 3 months. * Patients with a life expectancy \<12 weeks. * All patients being treated with drugs not listed in the Protocol Appendix C.
References
Publications (1)
- DERIVEDPassardi A, Serra P, Caffo O, Masini C, Brugugnoli E, Vespignani R, Giardino V, Petracci E, Bartolini G, Sullo F, Anesi C, Dianti M, Eccher C, Piras EM, Gios L, Campomori A, Oberosler V, Forti S. Use of the ONCO-TreC electronic diary compared with a standard paper diary to improve adherence to oral cancer therapy in patients with solid and haematological tumours: protocol for a randomised controlled trial. BMJ Open. 2022 Jan 11;12(1):e055814. doi: 10.1136/bmjopen-2021-055814. PMID 35017254