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

  • STATUS
    Recruiting
  • End date
    May 6, 2023
  • participants needed
    124
  • sponsor
    Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Updated on 6 November 2021
immunostimulants

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:

  1. 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.

Details
Condition cancers, Cancer, hematological malignancies, malignant tumor, oral administration, Hematological Disorders, Ewing's Family Tumors, hematological malignancy, Solid Neoplasm, Cancer (Pediatric), hematological tumor, Solid Tumour, hematologic malignancies, Neoplasms, Solid Tumor, malignant tumors, Hematologic Cancer, primary cancer, Hematologic Malignancy, primary malignant neoplasm, Cancer/Tumors, malignancy, Hematologic Neoplasms, malignancies, oral drug administration, Blood Cancer, Blood disorder, haematological malignancy, Solid Tumors
Treatment TreC-Onco, Paper diary
Clinical Study IdentifierNCT04826458
SponsorIstituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Last Modified on6 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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