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Completed

NCT Number: NCT05552066

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de lutte contre le cancer Eugène Marquis

Rennes, 35042, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard follow up

Other

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

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).

Primary outcomes

  1. Duration of stay in day hospital unit

    Time frame: 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 outcomes

  1. patient satisfaction

    Time frame: 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)

  2. Caregiver satisfaction

    Time frame: Month3;Month6

    Assessed by self questionnaire

  3. Health related patient quality of life

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Collaborators

  • Ligue contre le cancer, France

Registry information

Official study 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

Acronym: ANTICIPRO

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2022
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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