Solid Malignant Tumor
Conditions
Keywords
PRO (Patient reported outcomes), Chemotherapy, immunotherapy, satisfaction
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. 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.
Interventions
OTHERStandard follow up
Patients enrolled into front phase will be followed in a standard way without any additional procedure except satisfaction questionnaire
OTHERshort 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).
Sponsors
Ligue contre le cancer, France
Center Eugene Marquis
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
1st stage: the current circuit remains unchanged (with sytematic medical or nursing validation to confirm chemotherapy administration).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of stay in day hospital unit | 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
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction | 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) |
| Caregiver satisfaction | Month3;Month6 | Assessed by self questionnaire |
| Health related patient quality of life | 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) |
Countries
France
Outcome results
None listed