Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cancer
  • Hematologic Malignancy
  • Oral Drug Administration
  • Solid Tumor
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 a...

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: describe the reasons for non-adherence in each group (eg. forgetfulness, side effects, misunderstanding of prescription), describe the patient's compliance with the instrument and modalities (electronic diary, paper diary) through a short questionnaire 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.

Tracking Information

NCT #
NCT04826458
Collaborators
Not Provided
Investigators
Study Chair: Alessandro Passardi, MD IRCCS IRST