Solid Tumor, Adult
Conditions
Keywords
digital application, outpatients chemotherapy, chemotherapy validation
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)
Interventions
PROCEDUREChemotherapy 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.
Sponsors
Institut Paoli-Calmettes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactDominique Genre, MD
Outcome results
None listed