Clinical Trials Logo
  1. Home
  2. Patient Satisfaction
  3. NCT05910164

Patient Preference Between a Prefilled Syringe or a Prefilled Pen Device for Administration of Pegfilgrastim — PELGRAZ  

Patient Satisfaction Clinical Trial

Official 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05910164
Study type Observational
Source Institut Rafael
Contact
Status Active, not recruiting
Phase
Start date June 9, 2023
Completion date October 9, 2024
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04079543 - NPO and Patient Satisfaction in the Cath Lab N/A
Enrolling by invitation NCT05053958 - Using Superimposition of Intra-Oral Scan and CBCT in Single Implant Restorations in Aesthetic Zone. N/A
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT04774562 - The Effect of Video-Assisted Discharge Education After Total Hip Replacement Surgery N/A
Terminated NCT04604340 - Radial Versus Femoral Arterial Access for Cerebral Angiography in Adolescents N/A
Recruiting NCT04539210 - Screw-retained Maxillary Complete Denture With Electric Welded Metal Framework Versus Cast One, Patient Satisfaction Assessment. N/A
Completed NCT02924974 - Spinal Morphine in Robotic Assisted Radical Prostatectomy Phase 4
Completed NCT01052415 - POL and Access Intervention to Reduce HIV Stigma Among Service Providers in China N/A
Recruiting NCT06044103 - Patient-controlled Sedation During Repair of Obstetric Perineal Lacerations Phase 4
Not yet recruiting NCT05670080 - Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair? N/A
Completed NCT06114524 - Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation N/A
Completed NCT06141122 - The Colonoscopy Booklet:Effect of a Recipe Resource on Quality of Colonoscopy Bowel Preparation and Patient Experience N/A
Not yet recruiting NCT04534868 - Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area N/A
Completed NCT04823390 - Anesthetist Controlled Versus Patient-controlled Sedation: Risks and Benefits Phase 1
Recruiting NCT05884684 - What is the Potential Impact of Reviewing Post-procedure Images With Patients Following Interventional Spine Procedures. N/A
Recruiting NCT05613439 - The Fast-track Centre for Hip and Knee Replacement Database
Recruiting NCT06451510 - Knee Osteoarthritis in the Region of Norrbotten
Withdrawn NCT04625842 - Focus Group Interview Study on Patient Experiences and Satisfaction N/A
Completed NCT04420000 - Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing N/A
Recruiting NCT04842240 - Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction.