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

Not Applicable

• Conditions: Solid Tumor, Adult
• Interventions: Procedure: Chemotherapy prevalidation

• Registration Number: NCT03977766
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-05
• Last Update Submitted: 2019-06-05
• Study First Posted: 2019-06-06
• Last Update Posted: 2019-06-06
• Study Start: 2019-10-15
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nurse then patient digital prevalidation of chemotherapy	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity of the digital application	6 weeks	Number of prevalidation of the chemotherapy by the digital application compared to the number of corresponding validation of the chemotherapy by the physician