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OpenTrials
Completed

NCT Number: NCT04008056

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

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.

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Key information

Conditions

Digestive Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Reported Outcome questionnaire

Other

34 question form to assess patient symptoms

Primary outcomes

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

    Time frame: Day 1

    Yes/no

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

    Time frame: Day 1

    Yes/no

Secondary outcomes

  1. Cost of unused pouches of prepared chemotherapy according to decisions

    Time frame: Day 1

    Euros

  2. Authorization for preparation of chemotherapy based on biological results (decision 1)

    Time frame: Day 0

    Yes/no

  3. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: PRO Link

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 5, 2019
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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