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

Digestive Cancer Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008056
• Other study ID #: NIMAO/2017-03/MF-01
• Status: Completed
• Start date: November 16, 2019
• Est. completion date: December 11, 2021

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 11, 2021
• Est. primary completion date: November 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive Cancer
• Gastrointestinal Neoplasms

Intervention

Other:
• Patient Reported Outcome questionnaire
34 question form to assess patient symptoms

Locations

Country	Name	City	State
France	CHU de Nimes	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Authorization for preparation of chemotherapy based on clinical information (decision 2)	Yes/no	Day 1
Primary	Authorization for preparation of chemotherapy based on patient reported outcome (decision 3)	Yes/no	Day 1
Secondary	Cost of unused pouches of prepared chemotherapy according to decisions	Euros	Day 1
Secondary	Authorization for preparation of chemotherapy based on biological results (decision 1)	Yes/no	Day 0
Secondary	Patient satisfaction with the patient reported outcome questionnaire	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)