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

NCT ID: NCT04008056

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-16

Study Completion Date

2021-12-11

Brief Summary

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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

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Conditions

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Digestive Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients undergoing chemotherapy

Group Type EXPERIMENTAL

Patient Reported Outcome questionnaire

Intervention Type OTHER

34 question form to assess patient symptoms

Interventions

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Patient Reported Outcome questionnaire

34 question form to assess patient symptoms

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mireille Favier

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

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CHU de Nimes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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NIMAO/2017-03/MF-01

Identifier Type: -

Identifier Source: org_study_id