Impact of Patient Reported Outcomes for Pre-chemotherapy Medical Decision in Day Patients With Digestive Cancer

Centre Hospitalier Universitaire de Nīmes1 site in 1 country138 target enrollmentNovember 16, 2019

ConditionsDigestive Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Digestive Cancer
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 138
Locations: 1
Primary Endpoint: Authorization for preparation of chemotherapy based on clinical information (decision 2)
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The investigators hypothesize that an early assessment of the clinical toxicity of the patient is possible via patient reported outcomes and that this information provides at least the same information level as the clinical examination of the patient made by the doctor. The early decision to prepare chemotherapy medications based on the indirect early collection of clinical information from the patient via a patient reported outcome should help minimize the number of chemotherapy medications destroyed.

Registry

clinicaltrials.gov

Start Date

November 16, 2019

End Date

December 11, 2021

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient must have given their free and informed consent and signed the consent form
•The patient must be a member or beneficiary of a health insurance plan
•Patient is undergoing at least their second chemotherapy regime (outside weekly scheme or protocol with cisplatin requiring hospitalization) for a digestive tumor
•Patient has a Smartphone or access to the internet (via tablet or computer)
•The patient is under consultation as a day patient in the Oncology Department of Nimes hosptial

Exclusion Criteria

•The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
•The subject refuses to sign the consent
•It is impossible to give the subject informed information
•The patient is under safeguard of justice or state guardianship
•The patient is pregnant, parturient or breastfeeding
•Patient has already participated in the study
•Patient undergoing first chemotherapy regime

Outcomes

Primary Outcomes

Authorization for preparation of chemotherapy based on clinical information (decision 2)

Time Frame: Day 1

Yes/no

Authorization for preparation of chemotherapy based on patient reported outcome (decision 3)

Time Frame: Day 1

Yes/no

Secondary Outcomes

Cost of unused pouches of prepared chemotherapy according to decisions(Day 1)
Authorization for preparation of chemotherapy based on biological results (decision 1)(Day 0)
Patient satisfaction with the patient reported outcome questionnaire(Before starting chemotherapy (Up to 72 hours prior to treatment starting))