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

NCT04826458 | Completed

• 1 other identifier: IRST100.28
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumor; Hematologic Malignancy; Oral Drug Administration; Cancer

Keywords

cancer; oral therapy; mobile app; electronic diary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• non-adherence reasons

  36 months

• Patient compliance

  36 months

• cost analysis

  36 months

Study Arms (2)

A. electronic diary (TreC-Onco)

EXPERIMENTAL

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

B. paper diary

OTHER

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

Interventions

TreC-Onco DEVICE

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.

Also known as: electronic diary

A. electronic diary (TreC-Onco)

Paper diary OTHER

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.

B. paper diary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (2)

Irst Irccs

Meldola, FC, 47014, Italy

Location

Ospedale Civile Santa Chiara di Trento

Trento, 38122, Italy

Location

Related Publications (1)

• 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.

  PMID: 35017254 DERIVED

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Alessandro Passardi, MD

  IRCCS IRST

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: May 4, 2021
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Begining 9 months and ending 36 months following publication
• Access Criteria: Proposals may be submitted up to 36 months after pubblication. URL will be provided on a later timepoint.

Locations

IT (2)