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

NCT03977766 | Unknown

• 1 other identifier: CPV 2.0-IPC 2018-054
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Solid Tumor, Adult

Keywords

digital application; outpatients chemotherapy; chemotherapy validation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

nurse then patient digital prevalidation of chemotherapy

EXPERIMENTAL

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

Interventions

Chemotherapy prevalidation PROCEDURE

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.

nurse then patient digital prevalidation of chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Officials

• Loui Tassy

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Genre, MD

CONTACT

+33491223778; drci.up@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 6, 2019
• Study Start: October 15, 2019
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: June 6, 2019

Record last verified: 2019-06