Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04008056
Recruitment Status : Recruiting
First Posted : July 4, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment
Digestive Cancer Other: Patient Reported Outcome questionnaire

Layout table for study information
Study Type : Observational
Estimated Enrollment : 138 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Patient Reported Outcomes for Pre-chemotherapy Medical Decision in Day Patients With Digestive Cancer
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Day patients treated by chemotherapy for a digestive tumor in the Oncology Department of Nimes hospital.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008056


Contacts
Layout table for location contacts
Contact: Mireille Favier 04.66.68.32.92 mireille.favier@chu-nimes.fr

Locations
Layout table for location information
France
CHU de Nimes Recruiting
Nimes, France, 30029
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Mireille Favier         
Sub-Investigator: Stéphane Obled         
Sub-Investigator: Valérie Phoutthasang         
Sub-Investigator: Virginie Loriot         
Sub-Investigator: Patrice Wolff         
Sub-Investigator: Christelle Cousin         
Sub-Investigator: Géraldine Leguelinel-Blache         
Sub-Investigator: Bénédicte Brunaud-Gagniard         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Layout table for investigator information
Principal Investigator: Mireille Favier CHU Nimes

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04008056     History of Changes
Other Study ID Numbers: NIMAO/2017-03/MF-01
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases