Clinical trial NCT05552066: Anticipated Personalization of the Management in Day Hospital Unit Based on a Collection of the PROs Via a Digital Tool
Official title: Before and After Study, Evaluating the Efficiency of an Anticipated Personalization of the Management in Day Hospital Unit Based on a Collection of the PROs Via a Digital Tool
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Malignant Tumor
Keywords: PRO (Patient reported outcomes)
Chemotherapy
immunotherapy
satisfaction
Lead sponsor: Center Eugene Marquis
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
First posted: 2022-09-23
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1st stage: the current circuit remains unchanged (with sytematic medical or nursing validation to confirm chemotherapy administration).
Primary purpose: OTHER

Brief 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.


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

Primary outcomes:
measure: Duration of stay in day hospital unit
timeFrame: Immediately after the chemotherapy
Secondary outcomes:
measure: patient satisfaction
timeFrame: Immediately after the chemotherapy
measure: Caregiver satisfaction
timeFrame: Month3;Month6
measure: Health related patient quality of life
timeFrame: Immediately after the chemotherapy
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre de lutte contre le cancer Eugène Marquis
Study officials:
References: