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

Completed

• Conditions: Digestive Cancer
• Interventions: Other: Patient Reported Outcome questionnaire

• Registration Number: NCT04008056
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Study Start: 2019-11-16
• Status Verified: 2021-08
• Primary Completion: 2021-11-11
• Study Completion: 2021-12-11
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing chemotherapy	Patient Reported Outcome questionnaire	-

Primary Outcome Measures

Name	Time	Method
Authorization for preparation of chemotherapy based on clinical information (decision 2)	Day 1	Yes/no
Authorization for preparation of chemotherapy based on patient reported outcome (decision 3)	Day 1	Yes/no

Secondary Outcome Measures

Name	Time	Method
Authorization for preparation of chemotherapy based on biological results (decision 1)	Day 0	Yes/no
Patient satisfaction with the patient reported outcome questionnaire	Before starting chemotherapy (Up to 72 hours prior to treatment starting)	System Usability Scale (SUS); score between 0-100 where the higher the score, the more satisfied the patient is.
Cost of unused pouches of prepared chemotherapy according to decisions	Day 1	Euros

Trial Locations

Locations (1)

CHU de Nimes; 🇫🇷 Nimes, France