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

Not Applicable

Recruiting

• Conditions: Solid Malignant Tumor
• Interventions: Other: Standard follow up; Other: short circuit

• Registration Number: NCT05552066
• Lead Sponsor: Center Eugene Marquis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-01-11
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-10-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 146

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
front phase	Standard follow up	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.
Post Phase	short circuit	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.

Primary Outcome Measures

Name	Time	Method
Duration of stay in day hospital unit	Immediately after the chemotherapy	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

Secondary Outcome Measures

Name	Time	Method
Health related patient quality of life	Immediately after the chemotherapy	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)
Caregiver satisfaction	Month3;Month6	Assessed by self questionnaire
patient satisfaction	Immediately after the chemotherapy	Assessed by EORTC OUT-PATSAT7 ( patient satisfaction with cancer care core questionnaire).; satisfaction score between 0 (no satisfaction) and 100 (high satisfaction)

Trial Locations

Locations (1)

Centre de lutte contre le cancer Eugène Marquis; 🇫🇷 Rennes, France