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

February 25, 2021 updated by: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII, Bergamo
      • Meldola (FC), Italy, 47014
        • Irst-Irccs
      • Trento, Italy, 38123
        • Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cancer patients undergoing oral therapy
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.
Device: TreC-Onco

TreC-Onco is composed of two tools aimed at supporting patient self-care and health professional monitoring and intervention:

  1. 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.
  2. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug accountability comparison
Time Frame: 3 years
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.
3 years
Toxicity reporting comparison
Time Frame: 3 years
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System acceptability: HADS questionaire
Time Frame: 3 years
HADS questionaire will be analyzed using the Wilcoxon rank-sum test
3 years
System acceptability: FACT-B questionaire
Time Frame: 3 years
FACT-B questionaire will be analyzed using the Wilcoxon rank-sum test
3 years
System usability: system usability scale (SUS) questionaire
Time Frame: 3 years
system usability scale (SUS) will be analyzed using the Wilcoxon rank-sum test
3 years
System acceptability by the Q-pre questionaire
Time Frame: 3 years
System acceptability by the Q-pre questionaire using content and template qualitative sociological analysis
3 years
System acceptability by the Q-post questionaire
Time Frame: 3 years
System acceptability by the Q-post questionaire using content and template qualitative sociological analysis
3 years
System acceptability by semi-structured interviews
Time Frame: 3 years
System acceptability by semi-structured interviews using content and template qualitative sociological analysis
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Collaborators

Kessler Foundation

Investigators

  • Study Chair: Alessandro Passardi, MD, IRST IRCCS, Meldola (FC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2016

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRST100.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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