Anticipated Personalization of the Management in Day Hospital Unit Based on a Collection of the PROs Via a Digital Tool (ANTICIPRO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Malignant Tumor
• Intervention / Treatment: Other: Standard follow up; Other: short circuit

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LAGUERRE Brigitte, Dr; Phone Number: 033 02 99 25 31 82; Email: b.laguerre@rennes.unicancer.fr
• Study Contact Backup: Name: JOLAINE Valerie, Mme; Phone Number: 033 02 99 25 30 36; Email: v.jolaine@rennes.unicancer.fr

Study Locations

• France
  • Rennes, France, 35042
    • Recruiting
    • Centre de lutte contre le cancer Eugène Marquis
    • Contact: JOLAINE Valérie; Phone Number: 0299253023; Email: v.jolaine@rennes.unicancer.fr
    • Principal Investigator: LAGUERRE Brigitte, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: front phase; The current circuit remains unchanged (medical or nursing validation to confirm chemotherapy administration). Patient satisfaction is collected at each visit to the day hospital unit for chemotherapy.	Other: Standard follow up; Patients enrolled into front phase will be followed in a standard way without any additional procedure except satisfaction questionnaire
Other: Post Phase; 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.	Other: short circuit; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of stay in day hospital unit	Assess the impact on the duration of stay of an anticipated personalization of the stay in HDJ based on a platform of analysis of the PROs collected the day before and the implementation of a short circuit	Immediately after the chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	Assessed by EORTC OUT-PATSAT7 ( patient satisfaction with cancer care core questionnaire). satisfaction score between 0 (no satisfaction) and 100 (high satisfaction)	Immediately after the chemotherapy
Caregiver satisfaction	Assessed by self questionnaire	Month3;Month6
Health related patient quality of life	Assessed by EQ5D-5L (EuroQuol Five Dimension - Five Level Health Survey questionnaire) The scale has five subcomponents with scores from 1 (best) to 5 (worst)	Immediately after the chemotherapy

Collaborators and Investigators

• Sponsor: Center Eugene Marquis
• Collaborators: Ligue contre le cancer, France

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: immunotherapy; satisfaction; Chemotherapy; PRO (Patient reported outcomes)
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2022-3-29-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No