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Clinical Trial Summary

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.


Clinical Trial Description

This is a multicenter, interventional, non-pharmacological study on a app for oral anticancer therapy management. 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. The secondary objectives of the study are: 1. describe the reasons for non-adherence in each group (eg. forgetfulness, side effects, misunderstanding of prescription), 2. describe the patient's compliance with the instrument and modalities (electronic diary, paper diary) through a short questionnaire 3. description of the costs related to therapeutic non-adherence. A total of 124 patients will be considered: enrollment will take place consecutively until the predetermined number is reached. Eligible patients will be randomized in a 1:1 ratio using a balanced procedure a blocks exchanged to one of the following interventions, stratified by type of therapy (chemotherapy vs. biological therapy): A. electronic diary B. paper diary The electronic diary consist of an Android app (for Android version 2.2 and later) for mobile devices, which acts as a diary for the patient. Adherence will be assessed at each treatment cycle by counting the remaining tablets. For patients with disease progression within six treatment cycles, the assessment of adherence and therefore the count of the remaining tablets will end on the date of progression. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04826458
Study type Interventional
Source Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Contact Patrizia Serra, Dr
Phone +39 0543 739100
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date May 2021
Completion date May 2023

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