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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04008056
Acronym
PRO Link
Enrollment
138
Registered
2019-07-05
Start date
2019-11-16
Completion date
2021-12-11
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive Cancer

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.

Interventions

OTHERPatient Reported Outcome questionnaire

34 question form to assess patient symptoms

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Authorization for preparation of chemotherapy based on clinical information (decision 2)Day 1Yes/no
Authorization for preparation of chemotherapy based on patient reported outcome (decision 3)Day 1Yes/no

Secondary

MeasureTime frameDescription
Cost of unused pouches of prepared chemotherapy according to decisionsDay 1Euros
Authorization for preparation of chemotherapy based on biological results (decision 1)Day 0Yes/no
Patient satisfaction with the patient reported outcome questionnaireBefore 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026