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

NCT ID: NCT05552066

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-11

Study Completion Date

2025-06-01

Brief Summary

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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

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Conditions

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Solid Malignant Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Standard follow up

Intervention Type OTHER

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

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.

Group Type OTHER

short circuit

Intervention Type 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).

Interventions

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Standard follow up

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

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ligue contre le cancer, France

OTHER

Sponsor Role collaborator

Center Eugene Marquis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre de lutte contre le cancer Eugène Marquis

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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2022-3-29-001

Identifier Type: -

Identifier Source: org_study_id

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