Pilot Study on the Use of iENTER, iCONSENT and iPARTICIPATE E-tools

Cancer Clinical Trial

Official title:

Pilot Study on the Use of iENTER, iCONSENT and iPARTICIPATE E-tools

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06317961
• Other study ID #: INT200-22
• Status: Recruiting
• Start date: April 5, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Precision oncology is the future of fighting cancer. Cancer Core Europe (CCE) developed a precision medicine trial, i.e. the Basket of Basket (BoB) study, to provide personalised treatment to a large number of patients by incorporating a molecular profiling platform. The EU-funded CCE_DART project, developed within the CCE Consortium, is aimed at improving efficiency and transform platform trials into data-rich translational research programmes. Within the CCE_DART project working area D "Patient involvement through information and partnership" three interconnected web e-tools were developed aimed at promoting patient information, recruitment, and involvement as well as facilitating adherence to the CCE BoB trial: 1) iENTER: informative web site addressed to potential BoB trial participants, their caregivers, patients' advocates, and the public; 2) iCONSENT: web app for remote management of the informed consent process in the CCE BoB trial.3) iPARTICIPATE: web app allowing remote access to BoB trial patients trial visits calendar, medications list and posology, to upload documents and download reports, messaging between patients and clinical staff. The main objective of this study is to carry out field testing and assess usability of the e-tools iENTER, iCONSENT and iPARTICIPATE. The study is also addressed at collecting patients' suggestions for improvements of the e-tools.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cancer patients, or their informal caregivers, candidates to precision oncology trials. Patients or caregivers able to surf the internet and to fill in a simple online form.

Exclusion Criteria:

• People with clinically evident cognitive impairment.

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano	The Netherlands Cancer Institute, Vall d'Hebron Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUS questionnaire	The SUS questionnaire consists of 10 Likert type items with five response options (from Strongly agree to Strongly disagree).	31-1-2025

External Links

•   Building Data Rich Clinical Trials CCE_DART is an innovative EU-funded project dedicated to deliver novel methods for the design and implementation of newer, more efficient and effective clinical trials in oncology
•   This website provides information that may be helpful in the process of decision making about clinical trial participation. It is targeted to patients and/or their caregivers, but it can also be used by the general public.