Clinical trial NCT04826458: Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology
Official title: Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Solid Tumor
Hematologic Malignancy
Oral Drug Administration
Keywords: cancer
oral therapy
mobile app
electronic diary
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence: drug accountability
timeFrame: 36 months
Secondary outcomes:
measure: non-adherence reasons
timeFrame: 36 months
measure: Patient compliance
timeFrame: 36 months
measure: cost analysis
timeFrame: 36 months
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Irst Irccs
state: FC
city: Trento
country: Italy
facility: Ospedale Civile Santa Chiara di Trento
Study officials:
affiliation: IRCCS IRST
name: Alessandro Passardi, MD
role: STUDY_CHAIR
References:
citation: Passardi A, Serra P, Caffo O, Masini C, Brugugnoli E, Vespignani R, Giardino V, Petracci E, Bartolini G, Sullo F, Anesi C, Dianti M, Eccher C, Piras EM, Gios L, Campomori A, Oberosler V, Forti S. Use of the ONCO-TreC electronic diary compared with a standard paper diary to improve adherence to oral cancer therapy in patients with solid and haematological tumours: protocol for a randomised controlled trial. BMJ Open. 2022 Jan 11;12(1):e055814. doi: 10.1136/bmjopen-2021-055814.