Patient Preference Between a Prefilled Syringe or a Prefilled Pen Device for Administration of Pegfilgrastim
- Conditions
- Patient SatisfactionFebrile Neutropenia, Drug-InducedPatient Preference
- Interventions
- Device: PELGRAZ prefilled syringe or PELGRAZ prefilled pen
- Registration Number
- NCT05910164
- Lead Sponsor
- Institut Rafael
- Brief Summary
Febrile neutropenia (NF) is a common serious complication of cancer chemotherapy. Outpatient management of chemotherapy treatments is made essential by the volume of patients treated, respect for their quality of life and the lack of hospitalization resources.
The prevention of NF is well documented and its success depends on the risks of developing NF related to the type of chemotherapy protocol used and the profile of the patient and his disease.
Pegfilgrastim (G-CSF, biosimilar medicine) injection has been shown to prevent (febrile) neutropenia. It is routinely prescribed on an outpatient basis for patients treated with chemotherapy (CT), several thousand times a year in our geographical area.
In order to take into account patient preferences and help clinical decision-making, this study will be conducted on the basis of self-administered questionnaires. The aim of the research is to assess patient preference for receiving administration of PELGRAZ (Accord Healthcare) using a prefilled syringe or a prefilled pen device. In a second step, this study will evaluate the learning of the patient and his autonomy during a pen self-injection guided by a nurse.
- Detailed Description
Febrile neutropenia (NF) is a common serious complication of cancer chemotherapy. Outpatient management of chemotherapy treatments is made essential by the volume of patients treated, respect for their quality of life and the lack of hospitalization resources.
The prevention of NF is well documented and its success depends on the risks of developing NF related to the type of chemotherapy protocol used and the profile of the patient and his disease.
Pegfilgrastim (G-CSF, biosimilar medicine) injection has been shown to prevent (febrile) neutropenia. It is routinely prescribed on an outpatient basis for patients treated with chemotherapy (CT), several thousand times a year in our geographical area.
In order to take into account patient preferences and help clinical decision-making, this study will be conducted on the basis of self-administered questionnaires.
This research involves the administration/use of a product (PELGRAZ, Accord Healthcare) within its intended purpose. PELGRAZ prefilled syringe or prefilled pen are available on the European Union market.
The study will be carried out using a crossover design. Two modes of administration (syringe and pen) will be compared. Each subject will receive either the sequence syringe then pen, or pen then syringe.
The trial will be conducted among 150 cancer patients for whom a chemotherapy followed by the administration of pegfilgrastim is indicated.
The primary endpoint is a composite endpoint consisting of several parameters related to patient preference.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 18 years old and older
- Patients with solid tumors, Hodgkin's lymphoma, non-Hodgkin's lymphoma and receiving myelosuppressive chemotherapy with a risk of NF of 10-20% (individual risk factors), or ≥ 20% (primary prevention of neutropenia) and receiving PELGRAZ ® in accordance with CPR
- Prediction of the risk of NF without filgrastim or pegfilgrastim determined according to the recommendations of the EORTC
- ECOG ≤ 2
- Free and informed consent obtained
- Patient affiliated to a social security system or beneficiary of such a scheme
- Pregnancy
- Breastfeeding
- Patients receiving concurrent radiotherapy
- Second cancer treated with chemotherapy
- Participation in any other clinical trial within 30 days prior to recruitment
- Concomitant myelosuppressive therapy, e.g. ex. immunosuppressive therapy
- History of severe hypersensitivity reaction to drugs intended for use and/or drugs derived from E. coli
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description B) administration starting with prefilled pen PELGRAZ prefilled syringe or PELGRAZ prefilled pen - Group B = Phase 2, 3, 4 then phase 1 The study protocol consists of 4 different stages * Phase 1: injection by pre-filled syringe by a state-certified nurse (IDE) * Phase 2: pen injection guided (thanks to the detailed information) by the IDE * Phase 3: injection by pen in autonomy supervised by the IDE (can only interfere in case of non-compliance with the injection protocol) = Learning phase * Phase 4: injection by pen in complete autonomy, patient alone A) administration starting with prefilled syringe PELGRAZ prefilled syringe or PELGRAZ prefilled pen - Group A = Phase 1 then phases 2, 3, 4 The study protocol consists of 4 different stages * Phase 1: injection by pre-filled syringe by a state-certified nurse (IDE) * Phase 2: pen injection guided (thanks to the detailed information) by the IDE * Phase 3: injection by pen in autonomy supervised by the IDE (can only interfere in case of non-compliance with the injection protocol) = Learning phase * Phase 4: injection by pen in complete autonomy, patient alone
- Primary Outcome Measures
Name Time Method questionnaire 120 days The primary endpoint is a composite endpoint consisting of several parameters related to patient preference
- Secondary Outcome Measures
Name Time Method questionnaire, specific questions 120 days 1. patient learning and empowerment during self-injection
2. pain evaluation
3. duration of treatment;
4. patient satisfaction;
5. overview of the health, physical and psychological conditions of the patient according to his own perception;
Trial Locations
- Locations (1)
Institut Rafael
🇫🇷Levallois-Perret, Ile-de-France, France