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

Primary Purpose

Cancer, Solid Tumor, Hematologic Malignancy

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TreC-Onco
Paper diary
Sponsored by
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cancer focused on measuring cancer, oral therapy, mobile app, electronic diary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Irst IrccsRecruiting
  • Ospedale Civile Santa Chiara di TrentoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

A. electronic diary (TreC-Onco)

B. paper diary

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 29, 2021
Last Updated
October 21, 2021
Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
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1. Study Identification

Unique Protocol Identification Number
NCT04826458
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Solid Tumor, Hematologic Malignancy, Oral Drug Administration
Keywords
cancer, oral therapy, mobile app, electronic diary

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A. electronic diary (TreC-Onco)
Arm Type
Experimental
Arm Description
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.
Arm Title
B. paper diary
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TreC-Onco
Other Intervention Name(s)
electronic diary
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Paper diary
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence: drug accountability
Description
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.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
non-adherence reasons
Description
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.
Time Frame
36 months
Title
Patient compliance
Description
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.
Time Frame
36 months
Title
cost analysis
Description
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.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrizia Serra, Dr
Phone
+39 0543 739100
Email
patrizia.serra@irst.emr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Oriana Nanni, PhD
Phone
+39 0543 739100
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Passardi, MD
Organizational Affiliation
IRCCS IRST
Official's Role
Study Chair
Facility Information:
Facility Name
Irst Irccs
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizia Serra, Dr
Facility Name
Ospedale Civile Santa Chiara di Trento
City
Trento
ZIP/Postal Code
38122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orazio Caffo, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data available for sharing: Individual participant data that underlie the results reported in the pubblication, after deindentification (text, tables, figures and appendices
IPD Sharing Time Frame
Begining 9 months and ending 36 months following publication
IPD Sharing Access Criteria
Proposals may be submitted up to 36 months after pubblication. URL will be provided on a later timepoint.
Citations:
PubMed Identifier
35017254
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.
Results Reference
derived

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

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