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

NCT02921724 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-02-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Kessler Foundation

    collaborator OTHER

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    lead OTHER

Principal Investigators

  • Alessandro Passardi, MD · IRST IRCCS, Meldola (FC)

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-27
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02921724 on ClinicalTrials.gov