Clinical Trial 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.
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.
