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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04826458
• Other study ID #: IRST100.28
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2021
• Est. completion date: May 2023

Study information

• Verified date: October 2021
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: Patrizia Serra, Dr
• Phone: +39 0543 739100
• Email: patrizia.serra[@]irst.emr.it
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Hematologic Malignancy
• Hematologic Neoplasms
• Oral Drug Administration
• Solid Tumor

Intervention

Device:
• TreC-Onco
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.

Other:
• Paper diary
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.

Locations

Country	Name	City	State
Italy	Irst Irccs	Meldola	FC
Italy	Ospedale Civile Santa Chiara di Trento	Trento

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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