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NCT05552066 | Recruiting | Solid Malignant Tumor


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

Condition or disease

Solid Malignant Tumor

Intervention/treatment

Standard follow up

short circuit

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 146 participants
Masking : None (Open Label)
Primary Purpose : Other
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
Actual Study Start Date : January 11, 2022
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : April 1, 2025
Arm Intervention/treatment

Other: 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.

Other: Standard follow up

Other: 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.

Other: short circuit

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

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

Location Details


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

How to Participate

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Locations


Recruiting

France,

Eugène Marquis Cancer Center

Rennes, France, 35042

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