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

Study Overview
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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. 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.

Official Title
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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

Conditions
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Solid Malignant Tumor

Intervention / Treatment
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* Other: Standard follow up
* Other: short circuit


Participation Criteria
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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, Pembrolizumab, Folfox, Carboplatin, EC chemotherapy (Epirubicin/Cyclophosphamide) Affiliated and beneficiary to a social security system Informed and written consent 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1st stage: the current circuit remains unchanged (with sytematic medical or nursing validation to confirm chemotherapy administration).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: front phase<br>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<br>* Patients enrolled into front phase will be followed in a standard way without any additional procedure except satisfaction questionnaire<br>|
| Other: Post Phase<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Caregiver satisfaction | Assessed by self questionnaire | Month3;Month6 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRO (Patient reported outcomes), Chemotherapy, immunotherapy, satisfaction