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

NCT02921724 | Unknown

• 1 other identifier: IRST100.18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer; Oral Drug Administration

Keywords

cancer; oral drug; sunitinib; capecitabine; mobile app

Outcome Measures

Primary Outcomes (2)

• 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.

  3 years

• 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.

  3 years

Secondary Outcomes (6)

• System acceptability: HADS questionaire

  3 years

• System acceptability: FACT-B questionaire

  3 years

• System usability: system usability scale (SUS) questionaire

  3 years

• System acceptability by the Q-pre questionaire

  3 years

• System acceptability by the Q-post questionaire

  3 years

Study Arms (1)

Cancer patients undergoing oral therapy

EXPERIMENTAL

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

Interventions

TreC-Onco DEVICE

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.

Cancer patients undergoing oral therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients receiving also intravenous anticancer treatment

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead
• Kessler Foundation: collaborator

Study Sites (3)

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

Bergamo, 24127, Italy

Location

Irst-Irccs

Meldola (FC), 47014, Italy

Location

Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento

Trento, 38123, Italy

Location

Related Publications (2)

• 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.

  PMID: 35080505 DERIVED

• 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.

  PMID: 28554917 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Alessandro Passardi, MD

  IRST IRCCS, Meldola (FC)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: October 3, 2016
• Study Start: January 27, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

IT (3)