Clinical trial NCT02921724: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Oral Drug Administration
Keywords: cancer
oral drug
sunitinib
capecitabine
mobile app
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
Collaborators: name: Kessler Foundation
First posted: 2016-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Drug accountability comparison
timeFrame: 3 years
measure: Toxicity reporting comparison
timeFrame: 3 years
Secondary outcomes:
measure: System acceptability: HADS questionaire
timeFrame: 3 years
measure: System acceptability: FACT-B questionaire
timeFrame: 3 years
measure: System usability: system usability scale (SUS) questionaire
timeFrame: 3 years
measure: System acceptability by the Q-pre questionaire
timeFrame: 3 years
measure: System acceptability by the Q-post questionaire
timeFrame: 3 years
measure: System acceptability by semi-structured interviews
timeFrame: 3 years
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII, Bergamo
city: Meldola (FC)
country: Italy
facility: Irst-Irccs
city: Trento
country: Italy
facility: Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento
Study officials:
affiliation: IRST IRCCS, Meldola (FC)
name: Alessandro Passardi, MD
role: STUDY_CHAIR
References:
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.
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.