Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology

Conditions
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Cancer, Solid Tumor, Hematologic Malignancy, Oral Drug Administration

Intervention / Treatment
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* Device: TreC-Onco
* Other: Paper diary


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A. electronic diary (TreC-Onco)<br>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. | Device: TreC-Onco<br>* 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.<br>* Other names: electronic diary;|
| Other: B. paper diary<br>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. | Other: Paper diary<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence: drug accountability | To assess the effectiveness of the electronic diary in improving adherence to oral therapy. Adherence will be assessed at each treatment cycle by counting the remaining tablets, and tested using Fisher's exact test. The number of pills counted by the system will be compared with that counted by the physician as residual pills returned by the patient at the hospital visit. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-adherence reasons | to describe the reasons for non-adherence to treatment in each group (e.g. forgetfulness, side effects, misunderstanding of the prescription) through descriptive statistics: mean ± standard deviation (sd) or median and interquartile range for the variables continuous and absolute and relative frequency for categorical variables. | 36 months | 
| Patient compliance | describe the patient's compliance with the different strategies (paper diary or electronic) through a short questionnaire. Data are analysed through descriptive statistics: mean ± standard deviation (sd) or median and interquartile range for the variables continuous and absolute and relative frequency for categorical variables. | 36 months | 
| cost analysis | description of the costs associated with the lack of therapeutic adherence, both in terms of costs for drugs and overall health costs (hospitalizations, health services, access to the Emergency Department) (IRST center only). Data are analysed through descriptive statistics: mean ± standard deviation (sd) or median and interquartile range for the variables continuous and absolute and relative frequency for categorical variables. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, oral therapy, mobile app, electronic diary