Personalized management of chemotherapy based on patient feedback
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
This study is testing a new way to manage chemotherapy by using patient feedback to see if it can make their experience better and more efficient.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Center Eugene Marquis Academic / other |
| Drugs / interventions | Nivolumab, Pembrolizumab, bevacizumab, cetuximab, panitumumab, chemotherapy, immunotherapy, Cyclophosphamide |
| Locations | 1 site (Rennes) |
| Trial ID | NCT05552066 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the organization of the Day Hospital unit for patients receiving chemotherapy by utilizing a digital tool to collect patient-reported outcomes (PROs). The approach involves two phases: the first phase maintains the current process with systematic validation of chemotherapy administration, while the second phase allows for a streamlined process where patients may receive chemotherapy the day after their PROs are reviewed, without additional medical validation. The study will assess patient satisfaction at each visit to evaluate the effectiveness of this new management pathway.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are starting a new chemotherapy or immunotherapy protocol for solid malignancies.
Not a fit: Patients who are in a neo-adjuvant situation for breast cancer or lack access to a connected device or internet may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient satisfaction and streamline chemotherapy administration for patients with solid malignant tumors.
How similar studies have performed: While the specific approach of using PROs for personalized management in this context may be novel, similar studies utilizing patient feedback to improve treatment pathways have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rennes
- Centre de lutte contre le cancer Eugène Marquis — Rennes, France (Recruiting)
Study contacts
- Study coordinator: LAGUERRE Brigitte, Dr
- Email: b.laguerre@rennes.unicancer.fr
- Phone: 02 99 25 31 82
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.