CancerNCT04826458
Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology
A study testing TreC-Onco and Paper diary in people with Cancer and Solid Tumor, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor, Hematologic Malignancy
- What is being tested?
- TreC-Onco and Paper diary
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesItaly
- Study dates
- 4 May 2021to 11 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Irst Irccs
Meldola, FC, 47014
Ospedale Civile Santa Chiara di Trento
Trento, 38122
About this study
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:
- 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.
Read the 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:
- 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.
- Conditions
- Cancer, Solid Tumor, Hematologic Malignancy, Oral Drug Administration
- Being tested
- TreC-Onco, Paper diary
- Keywords
- cancer, oral therapy, mobile app, electronic diary
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreC-OncoDevice
Also called electronic diary
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.
Paper diaryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Paper diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start4 May 2021
- Primary completion11 Nov 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Passardi, MD, Study chair, IRCCS IRST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826458
- Sponsor's protocol ID
- IRST100.28
- Status last verified
- Dec 2025
- First submitted
- 29 Mar 2021
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available for sharing: Individual participant data that underlie the results reported in the pubblication, after deindentification (text, tables, figures and appendices
Publications
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.
PubMed 35017254
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology
- ClinicalTrials.gov ID
- NCT04826458
- Acronym / sponsor ID
- IRST100.28
- Conditions
- Cancer, Solid Tumor, Hematologic Malignancy, Oral Drug Administration
- Keywords
- cancer, oral therapy, mobile app, electronic diary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. electronic diary (TreC-Onco) | Experimental | Device: TreC-OncoAt 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. |
| B. paper diary | Other | Other: Paper diaryPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreC-OncoAlso: electronic diaryAt 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 | A. electronic diary (TreC-Onco) |
| Paper diaryPatients 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 | B. paper diary |
Primary outcome
Adherence: drug accountability
Time frame: 36 months
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.
3 secondary outcomes
non-adherence reasons
Time frame: 36 months
Patient compliance
Time frame: 36 months
cost analysis
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Derived from this study: PubMed 35017254Passardi 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.
- Individual participant dataSharing planned: Yes. Data available for sharing: Individual participant data that underlie the results reported in the pubblication, after deindentification (text, tables, figures and appendices
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Passardi, MD study chair
IRCCS IRST
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TreC-Onco and Paper diary in people with Cancer and Solid Tumor, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence: drug accountability (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04826458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.