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Trial Title:
Anticipated Personalization of the Management in Day Hospital Unit Based on a Collection of the PROs Via a Digital Tool
NCT ID:
NCT05552066
Condition:
Solid Malignant Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
PRO (Patient reported outcomes)
Chemotherapy
immunotherapy
satisfaction
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
1st stage: the current circuit remains unchanged (with sytematic medical or nursing
validation to confirm chemotherapy administration).
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Standard follow up
Description:
Patients enrolled into front phase will be followed in a standard way without any
additional procedure except satisfaction questionnaire
Arm group label:
front phase
Intervention type:
Other
Intervention name:
short circuit
Description:
Patients included in the post phase will have to complete the "cem@santé" application. If
no contraindications are identified by the plateform with the remote PRO collection,
patients will undergo chemotherapy directly the next day (without any medical
validation).
Arm group label:
Post Phase
Summary:
The present study proposes a new organization of the Day Hospital unit with several
possible pathways defined by PRO.
The organization realies on a platform composed of nurses supervised by an IPA and a
doctor one day before a treatment in the day hospitalization unit admission, results of
PROs collectyed through the CEM@santé application (a French health care application) are
reviewed by nurses from the platform and chemotherapy delivery is confirmed.
The study is planed in 2 steps.
1. st stage: the current circuit remains unchanged (with systematic medical or nursing
validation to confirm chemotherapy administration. Patient satisfaction is collected
at each visit to the day hospital unit for chemotherapy. 73 patients will be
included in this phase.
2. nd stage: a short circuit is set up. If no contraindications are identified by the
plateform with the remote PRO collection, patients will undergo chemotherapy
directly the next day (without any medical validation. Patient satisfaction is also
collected at each visit to the day hospital unit for chemotherapy. 73 patients will
be included in this phase.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age greater than 18 years
- Patient treated for solid malignancy
- Patient starting a new chemotherapy or immunotherapy protocol.
- Patient receiving one of the following intravenous antineoplastic treatments in day
hospital: Nivolumab(1), Pembrolizumab(1), Folfox(2), Folfirinox(2), Xelox
Carboplatin, EC chemotherapy (Epirubicin/Cyclophosphamide)
- Affiliated and beneficiary to a social security system
- Informed and written consent
Note1: may be used in combination with tyrosine kinase inhibitors (TKIs) Note 2 :may be
used in combination with bevacizumab, cetuximab or panitumumab
Exclusion Criteria:
- Patient treated in neo-adjuvant situation for breast cancer
- Does not have a connected device (smartphone, tablet or computer)
- Does not have an internet connection
- Difficulty in filling out a questionnaire
- Protected adult or deprived of her liberty
- Pregnant or lactating woman
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre de lutte contre le cancer Eugène Marquis
Address:
City:
Rennes
Zip:
35042
Country:
France
Status:
Recruiting
Contact:
Last name:
JOLAINE Valérie
Phone:
0299253023
Email:
v.jolaine@rennes.unicancer.fr
Investigator:
Last name:
LAGUERRE Brigitte, Dr
Email:
Principal Investigator
Start date:
January 11, 2022
Completion date:
April 1, 2025
Lead sponsor:
Agency:
Center Eugene Marquis
Agency class:
Other
Collaborator:
Agency:
Ligue contre le cancer, France
Agency class:
Other
Source:
Center Eugene Marquis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05552066
