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

Institut Paoli-Calmettes

Status: Unknown

Conditions: Solid Tumor, Adult

Treatments: Procedure: Chemotherapy prevalidation

Study type: Interventional

Funder types: Other

Identifiers

NCT03977766

CPV 2.0-IPC 2018-054

Details and patient eligibility

About

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)

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

nurse then patient digital prevalidation of chemotherapy

Experimental group

Description:

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.

Treatment:

Procedure: Chemotherapy prevalidation