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

NCT05910164 | Completed

• 2 other identifiers: IR-2022/0011ID RCB: 2022-A01465-38
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Preference; Febrile Neutropenia, Drug-Induced; Patient Satisfaction

Keywords

patient preference; pegfilgrastim; chemotherapy prophylaxis; febrile neutropenia; survey; questionnaires

Outcome Measures

Primary Outcomes (1)

• questionnaire

  The primary endpoint is a composite endpoint consisting of several parameters related to patient preference

  120 days

Secondary Outcomes (1)

• questionnaire, specific questions

  120 days

Study Arms (2)

A) administration starting with prefilled syringe

\- 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

Device: PELGRAZ prefilled syringe or PELGRAZ prefilled pen

B) administration starting with 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

Device: PELGRAZ prefilled syringe or PELGRAZ prefilled pen

Interventions

PELGRAZ prefilled syringe or PELGRAZ prefilled pen DEVICE

PELGRAZ prefilled syringe or PELGRAZ prefilled pen https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz

A) administration starting with prefilled syringe; B) administration starting with prefilled pen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 patients for whom a chemotherapy treatment followed by PELGRAZ administration is indicated

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Rafael: lead

Study Sites (1)

Institut Rafael

Levallois-Perret, Île-de-France Region, 92300, France

Location

Related Publications (1)

• Scher N, Boudabous H, Partouche J, Rezaee-Vessal S, Ihout P, Rizzo C, Lamallem H, Bauduceau O, Darmon I, Bollet M, Draghi C, Toledano A. Enhancing patient-centered care: a randomized study on G-CSF administration preferences in chemotherapy-induced neutropenia. Support Care Cancer. 2024 Oct 22;32(11):743. doi: 10.1007/s00520-024-08929-x.

  PMID: 39436413 DERIVED

MeSH Terms

Conditions

Patient Preference; Chemotherapy-Induced Febrile Neutropenia; Patient Satisfaction; Febrile Neutropenia

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Alain TOLEDANO, MD

  Institut Rafael

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: June 9, 2023
• Primary Completion: September 9, 2023
• Study Completion: October 9, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-09

Locations

FR (1)