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

Solid Malignant Tumor Clinical Trial

— ANTICIPRO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552066
• Other study ID #: 2022-3-29-001
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: February 2024
• Source: Center Eugene Marquis
• Contact: LAGUERRE Brigitte, Dr
• Phone: 02 99 25 31 82
• Email: b.laguerre[@]rennes.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: April 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Malignant Tumor

Intervention

Other:
• Standard follow up
Patients enrolled into front phase will be followed in a standard way without any additional procedure except satisfaction questionnaire
• 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).

Locations

Country	Name	City	State
France	Centre de lutte contre le cancer Eugène Marquis	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Center Eugene Marquis	Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Caregiver satisfaction	Assessed by self questionnaire	Month3;Month6
Secondary	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