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

NCT04008056 | Completed

• 1 other identifier: NIMAO/2017-03/MF-01
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive Cancer

Outcome Measures

Primary Outcomes (2)

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

  Yes/no

  Day 1

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

  Yes/no

  Day 1

Secondary Outcomes (3)

• 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)

Study Arms (1)

Patients undergoing chemotherapy

EXPERIMENTAL

Other: Patient Reported Outcome questionnaire

Interventions

Patient Reported Outcome questionnaire OTHER

34 question form to assess patient symptoms

Patients undergoing chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Mireille Favier

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: November 16, 2019
• Primary Completion: November 11, 2021
• Study Completion: December 11, 2021
• Last Updated: December 18, 2025

Record last verified: 2021-08

Locations

FR (1)