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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Digestive Cancer

Treatments: Other: Patient Reported Outcome questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT04008056

NIMAO/2017-03/MF-01

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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138 participants in 1 patient group

Patients undergoing chemotherapy

Experimental group

Treatment:

Other: Patient Reported Outcome questionnaire