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

March 17, 2022 updated by: Centre Hospitalier Universitaire de Nīmes
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nimes, France, 30029
        • CHU de Nimes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Day patients treated by chemotherapy for a digestive tumor in the Oncology Department of Nimes hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing chemotherapy
Other: Patient Reported Outcome questionnaire
34 question form to assess patient symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Authorization for preparation of chemotherapy based on clinical information (decision 2)
Time Frame: Day 1
Yes/no
Day 1
Authorization for preparation of chemotherapy based on patient reported outcome (decision 3)
Time Frame: Day 1
Yes/no
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of unused pouches of prepared chemotherapy according to decisions
Time Frame: Day 1
Euros
Day 1
Authorization for preparation of chemotherapy based on biological results (decision 1)
Time Frame: Day 0
Yes/no
Day 0
Patient satisfaction with the patient reported outcome questionnaire
Time Frame: 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.
Before starting chemotherapy (Up to 72 hours prior to treatment starting)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Mireille Favier, Chu Nimes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 16, 2019

Primary Completion (ACTUAL)

November 11, 2021

Study Completion (ACTUAL)

December 11, 2021

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (ACTUAL)

July 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIMAO/2017-03/MF-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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