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

NCT05552066 | Completed

• 1 other identifier: 2022-3-29-001
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Solid Malignant Tumor

Keywords

PRO (Patient reported outcomes); Chemotherapy; immunotherapy; satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• patient satisfaction

  Immediately after the chemotherapy

• Caregiver satisfaction

  Month3;Month6

• Health related patient quality of life

  Immediately after the chemotherapy

Study Arms (2)

front phase

OTHER

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

Post Phase

OTHER

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

Interventions

Standard follow up OTHER

Patients enrolled into front phase will be followed in a standard way without any additional procedure except satisfaction questionnaire

front phase

short circuit OTHER

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).

Post Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center Eugene Marquis: lead
• Ligue contre le cancer, France: collaborator

Study Sites (1)

Centre de lutte contre le cancer Eugène Marquis

Rennes, 35042, France

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1st stage: the current circuit remains unchanged (with sytematic medical or nursing validation to confirm chemotherapy administration).

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 23, 2022
• Study Start: January 11, 2022
• Primary Completion: March 13, 2025
• Study Completion: June 1, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

FR (1)