Somatuline Autogel Preference and Health Economy Study

Ipsen26 enrolled

Overview

The primary aim of this study is to assess which method of lanreotide Autogel administration patients with neuroendocrine tumours prefer - self/partner administrations or healthcare provided administrations. The study will also assess if self/partner administration can be performed without loss of efficacy and with a preserved safety profile. The impact of self/partner administration on resource utilisation and costs will be studied. In addition, we will also assess the healthcare provider's experience of the two administration practices.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuroendocrine Tumour With Carcinoid Symptoms

Interventions

lanreotide (Autogel formulation)DRUG

90 mg or 120 mg once every 28th day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of written informed consent from the patient and their partner (if the partner will be administering the lanreotide Autogel injections during the self administration period) * Male or female aged 18 years of age or older * Treated with lanreotide Autogel 90 or 120 mg every 28th day for carcinoid symptoms on a stable dose for at least 3 months prior to inclusion. The patient is presumed to be clinically stable during the coming months * Neuroendocrine tumour confirmed by biopsy and visible on radiology Exclusion Criteria: * Has a history of hypersensitivity to the Investigational Medicinal Product or drugs with a similar chemical structure * Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study * Has a life expectancy less than a year, as judged by the Investigator * The patient or their partner is not considered competent in injection technique, as judged by the Investigator

Locations (10)

Aarhus University Hospital / Medisinsk afd. V

Aarhus, Denmark

Odense Univeristy Hospital / S-AMB

Odense, Denmark

Haukeland University Hospital / Kreftafd

Bergen, Norway

Outcomes

Primary Outcomes

Subject Preference for Self or Partner Administration

A global question was asked: 'If you could choose, which administration method would you like to use on a regular basis?' A) Healthcare professional provided injection B) Self/ partner administered injection

Time frame: Between week 30 to 34

Secondary Outcomes

Number of Patients Stating at Least One Injection Interfered With Daily Activities

The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'

Time frame: Between baseline to week 32, after each injection (8-9 injections)

Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing

The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'

Time frame: Between baseline to week 32, after each injection (8-9 injections)

Days Sick Leave

Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed through recording loss of production for subject through total number of days sick leave of the employed patients (n=6).

Time frame: Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)

Total Number of Visits to HCP Due to Carcinoid Symptoms

Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed by recording the total number of visits made by participants (n=12) to HCP due to carcinoid symptoms.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.