Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT04826458
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2021-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology
Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Organization:
Study Overview
Official Title:
Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: