Patient Satisfaction Clinical Trial
— PELGRAZOfficial title:
Single-center, Randomized, Crossover Clinical Study to Assess Patient Preference Between the Use of a Prefilled Syringe or a Prefilled Pen Device for Pegfilgrastim Administration (PELGRAZ) as Primary Prophylaxis of Chemotherapy-related Neutropenia
Verified date | July 2023 |
Source | Institut Rafael |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | October 9, 2024 |
Est. primary completion date | September 9, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Institut Rafael | Levallois-Perret | Ile-de-France |
Lead Sponsor | Collaborator |
---|---|
Institut Rafael |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | questionnaire | The primary endpoint is a composite endpoint consisting of several parameters related to patient preference | 120 days | |
Secondary | questionnaire, specific questions | patient learning and empowerment during self-injection
pain evaluation duration of treatment; patient satisfaction; overview of the health, physical and psychological conditions of the patient according to his own perception; |
120 days |
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