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Participatory Research for Fine-tuning of a 2.0 System to Optimise Home Management of Oral Cancer Therapies.

Primary Purpose

Cancer, Oral Drug Administration

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TreC-Onco
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 drug, sunitinib, capecitabine, mobile app

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ECOG-Performance Status (PS) less or equal to 1;
  • life expectancy > 12 weeks;
  • candidate for treatment with capecitabine or sunitinib as monotherapy (adjuvant and advanced settings allowed);
  • clear understanding of the Italian language;
  • subjects who are, in the opinion of the Investigator, able to understand this study, to cooperate with the study procedures and able to manage mobile devices after basic training course held at baseline;
  • written informed consent

Exclusion Criteria:

  • Patients receiving also intravenous anticancer treatment

Sites / Locations

  • Azienda Ospedaliera Papa Giovanni XXIII, Bergamo
  • Irst-Irccs
  • Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cancer patients undergoing oral therapy

Arm Description

At the time of therapy prescription, patients candidate for oral therapy with capecitabine or sunitinib will be provided with informations on the side-effects of therapy and on the use and functions of the mobile diary app TreC-Onco. Patients are required to manually insert data into the mobile diary app at least once a day. Patients will be visited every 6 weeks. During the visit, the clinician will compare adherence and toxicity data entered into the mobile diary app with those directly reported by the patient and by drug accountability.

Outcomes

Primary Outcome Measures

Drug accountability comparison
the number of pills counted by the system (self-reported by the patient at home) will be compared with that counted by the physician as residual pills returned by the patient at the hospital visit. A difference in the number of pills within +/- 10% will be considered acceptable.
Toxicity reporting comparison
A comparison of type and grade of toxicity will be made between the adverse events indicated by the system and those reported by the patient/detected by the doctor at the clinical visit. The quality of the system will be considered adequate if all the grade 3 and at least 80% of the grade 2 toxicity data reported by the patient at the time of the visit is recorded in the app. A comparison will be made between the adverse event start time reported by the system and the time of data-entry by the patient into the system.

Secondary Outcome Measures

System acceptability: HADS questionaire
HADS questionaire will be analyzed using the Wilcoxon rank-sum test
System acceptability: FACT-B questionaire
FACT-B questionaire will be analyzed using the Wilcoxon rank-sum test
System usability: system usability scale (SUS) questionaire
system usability scale (SUS) will be analyzed using the Wilcoxon rank-sum test
System acceptability by the Q-pre questionaire
System acceptability by the Q-pre questionaire using content and template qualitative sociological analysis
System acceptability by the Q-post questionaire
System acceptability by the Q-post questionaire using content and template qualitative sociological analysis
System acceptability by semi-structured interviews
System acceptability by semi-structured interviews using content and template qualitative sociological analysis

Full Information

First Posted
September 26, 2016
Last Updated
February 25, 2021
Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Collaborators
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02921724
Brief Title
Participatory Research for Fine-tuning of a 2.0 System to Optimise Home Management of Oral Cancer Therapies.
Official Title
Participatory Research for Fine-tuning of a 2.0 System to Optimise Home Management of Oral Cancer Therapies.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 27, 2016 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (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
Collaborators
Kessler Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective testing-validation, interventional, non-pharmacological study on a new app for oral anticancer therapy management. A total of 80 patients will be considered: 20 evaluable patients in the training step; 60 patients in the validation step. In the training step will be considered evaluable the patients with: at least 6 weeks of treatment; visit at 6 weeks after the start of treatment performed and questionnaires self-administered. Patients will be visited every 6 weeks. In the training step, patients will remain under observation for a minimum of 6 weeks, until change of therapy (due to progression of disease, unacceptable toxicity, death, discontinuation) or for a maximum of 12 weeks. Patients enrolled in the validation step will remain under observation until change of therapy (due to progression of disease, unacceptable toxicity, death, discontinuation) or for a maximum of 24 weeks. The objective of this study is to assess the capability of a newly developed interactive health care application to support patients and health professionals in the shared management of oral anticancer therapies, improving adherence, preventing complications at home, toxicities, improper treatment reductions or interruptions, emergency accesses and to assess the system usability and acceptability by patients and health professionals, integration in the hospital workflow, monitoring over time patient perceived levels of quality of care, quality of life, social support, anxiety, and self-care capability.
Detailed Description
This is a prospective, interventional, non pharmacological study for testing-validation of a new app for optimising home management of oral therapies for cancer treatment. All patients will be treated according to the local clinical practice. Enrolment period: 8 (training step) + 12 (validation step) months. Total duration of the study: 36 months. This is a multicenter study. Objective of the study is to assess the capability of a newly developed interactive health care application to support patients and health professionals in the shared management of oral anticancer therapies, and to assess the system usability and acceptability by patients and health professionals. Eligible patients must meet the following criteria: adult 18-75 years old; Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1; candidate for treatment with capecitabine or sunitinib as monotherapy (adjuvant and advanced settings allowed); sufficient ability to manage mobile devices after basic training course held at baseline; clear understanding of the Italian language; written informed consent. Health professionals and patients define the items of the system through participatory design techniques (e.g. focus group sessions, joint review). To define whether the system is capable of monitoring patient adherence, the number of pills counted by the system (self-reported by the patient at home) will be compared with that counted by the physician as residual pills returned by the patient at the hospital visit. A difference in the number of pills within +/- 10% will be considered acceptable. A comparison of type and grade of toxicity will be made between the adverse events indicated by the system and those reported by the patient at the clinical visit. The quality of the system will be considered adequate if all the grade 3 and at least 80% of the grade 2 or more toxicity data reported by the patient at the time of the visit is recorded in the app. To investigate system usability and acceptability, Functional Assessment of Cancer Therapy-General (FACT-G) and Hospital Anxiety and Depression Scale (HADS) questionnaires will be used. Scores will be subdivided into different subscales and analyzed using the Wilcoxon rank-sum test. Two new questionnaires have been developed and will be used to evaluate patient expectations of the system, and system acceptability + patient-doctor communication. An internationally validated questionnaire translated into Italian on system usability (SUS) will be also administered at the end of observation. Conversational interviews will be audio-recorded, transcribed and analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Oral Drug Administration
Keywords
cancer, oral drug, sunitinib, capecitabine, mobile app

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cancer patients undergoing oral therapy
Arm Type
Experimental
Arm Description
At the time of therapy prescription, patients candidate for oral therapy with capecitabine or sunitinib will be provided with informations on the side-effects of therapy and on the use and functions of the mobile diary app TreC-Onco. Patients are required to manually insert data into the mobile diary app at least once a day. Patients will be visited every 6 weeks. During the visit, the clinician will compare adherence and toxicity data entered into the mobile diary app with those directly reported by the patient and by drug accountability.
Intervention Type
Device
Intervention Name(s)
TreC-Onco
Intervention Description
TreC-Onco is composed of two tools aimed at supporting patient self-care and health professional monitoring and intervention: Mobile diary app. This is an Android app (for Android version 2.2 and higher) that allows patients to record parameters related to their health state (e.g. medications; blood pressure, weight, fever; side-effects or other symptoms) through a mobile device. Data are stored in a central database and are made available in real time to health professionals through a web dashboard on the TreC server or through a tablet app. Web dashboard. Through this, oncologists can check patient data, monitoring their side-effects and adherence to prescriptions. The Dashboard is optimized for the Firefox browser in version 7 or higher.
Primary Outcome Measure Information:
Title
Drug accountability comparison
Description
the number of pills counted by the system (self-reported by the patient at home) will be compared with that counted by the physician as residual pills returned by the patient at the hospital visit. A difference in the number of pills within +/- 10% will be considered acceptable.
Time Frame
3 years
Title
Toxicity reporting comparison
Description
A comparison of type and grade of toxicity will be made between the adverse events indicated by the system and those reported by the patient/detected by the doctor at the clinical visit. The quality of the system will be considered adequate if all the grade 3 and at least 80% of the grade 2 toxicity data reported by the patient at the time of the visit is recorded in the app. A comparison will be made between the adverse event start time reported by the system and the time of data-entry by the patient into the system.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
System acceptability: HADS questionaire
Description
HADS questionaire will be analyzed using the Wilcoxon rank-sum test
Time Frame
3 years
Title
System acceptability: FACT-B questionaire
Description
FACT-B questionaire will be analyzed using the Wilcoxon rank-sum test
Time Frame
3 years
Title
System usability: system usability scale (SUS) questionaire
Description
system usability scale (SUS) will be analyzed using the Wilcoxon rank-sum test
Time Frame
3 years
Title
System acceptability by the Q-pre questionaire
Description
System acceptability by the Q-pre questionaire using content and template qualitative sociological analysis
Time Frame
3 years
Title
System acceptability by the Q-post questionaire
Description
System acceptability by the Q-post questionaire using content and template qualitative sociological analysis
Time Frame
3 years
Title
System acceptability by semi-structured interviews
Description
System acceptability by semi-structured interviews using content and template qualitative sociological analysis
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ECOG-Performance Status (PS) less or equal to 1; life expectancy > 12 weeks; candidate for treatment with capecitabine or sunitinib as monotherapy (adjuvant and advanced settings allowed); clear understanding of the Italian language; subjects who are, in the opinion of the Investigator, able to understand this study, to cooperate with the study procedures and able to manage mobile devices after basic training course held at baseline; written informed consent Exclusion Criteria: Patients receiving also intravenous anticancer treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Passardi, MD
Organizational Affiliation
IRST IRCCS, Meldola (FC)
Official's Role
Study Chair
Facility Information:
Facility Name
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Irst-Irccs
City
Meldola (FC)
ZIP/Postal Code
47014
Country
Italy
Facility Name
Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento
City
Trento
ZIP/Postal Code
38123
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35080505
Citation
Passardi A, Foca F, Caffo O, Tondini CA, Zambelli A, Vespignani R, Bartolini G, Sullo FG, Andreis D, Dianti M, Eccher C, Piras EM, Forti S. A Remote Monitoring System to Optimize the Home Management of Oral Anticancer Therapies (ONCO-TreC): Prospective Training-Validation Trial. J Med Internet Res. 2022 Jan 26;24(1):e27349. doi: 10.2196/27349.
Results Reference
derived
PubMed Identifier
28554917
Citation
Passardi A, Rizzo M, Maines F, Tondini C, Zambelli A, Vespignani R, Andreis D, Massa I, Dianti M, Forti S, Piras EM, Eccher C. Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study. BMJ Open. 2017 May 29;7(5):e014617. doi: 10.1136/bmjopen-2016-014617.
Results Reference
derived

Learn more about this trial

Participatory Research for Fine-tuning of a 2.0 System to Optimise Home Management of Oral Cancer Therapies.

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