Feasibility of a Process of Digital Validation of Chemotherapies in a Day Treatment Unit (CPV2-0)

Feasibility of a Process of Digital Validation of Outpatients Chemotherapies in a Day Treatment Unit

The aim of CPV 2.0 study is to evaluate a process of digital prevalidation of outpatients chemotherapy thanks to a numeric application. This digital tool is based on the combination of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to a decisional algorithm.

After cycle 1, chemotherapy digital prevalidation will be done with the help of a nurse for two consecutive cycles (cycles 2 and 3). Patients will then have to use to application by themselves for the two following cycles (cycles 4 and 5)

Study Overview

• Status: Unknown
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Procedure: Chemotherapy prevalidation

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age <80 (if age>70 years, a G8 score>14 is required)
• ECOG<3
• Pathology (solid tumor, in neoadjuvant, adjuvant or metastatic setting)
• Patient receiving an IV cytotoxic chemotherapy in a day treatlent unit for at least 5 cycles, with at least an injection at day 1, day 8 and day 15
• Familiar with digital tools

Exclusion Criteria:

• Emergency
• patient feeling unease with the use of a smartphone

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nurse then patient digital prevalidation of chemotherapy; Outpatient Chemotherapy prevalidation will done; with the help of a nurse, using the digital application, for cycle 2 and 3.; by the patient alone, using the digital application, for cycle 4 and 5.	Procedure: Chemotherapy prevalidation; Outpatient Chemotherapy prevalidation will done; with the help of a nurse, using the digital application, for cycle 2 and 3.; by the patient alone, using the digital application, for cycle 4 and 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of the digital application	Number of prevalidation of the chemotherapy by the digital application compared to the number of corresponding validation of the chemotherapy by the physician	6 weeks

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: Loui Tassy, Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2019
• Primary Completion (Anticipated): April 15, 2021
• Study Completion (Anticipated): April 15, 2021

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: digital application; outpatients chemotherapy; chemotherapy validation
• Other Study ID Numbers: CPV 2.0-IPC 2018-054

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No