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Completed

NCT Number: NCT04649580

United Kingdom (UK) Patient Preference Study of Somatuline Autogel and Treatment Administration Setting

The aim of the study is to generate real-world evidence to describe the patient experience of administration of Somatuline® Autogel® (lanreotide) in homecare and hospital settings, and the associated impact on healthcare utilisation, societal cost, work productivity and health-related quality of life (HRQoL)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a diagnosis of GEP-NETs
  • Patients on prescribed lanreotide Autogel®;
  • Patients who have switched from hospital to homecare administration setting at least 2 months ago
  • Patients judged to be on a stable dose; 120mg for tumour control or >1 injection at same dose for symptom control

Exclusion criteria

  • Patients who decline or lack capacity to consent to participate in the study

Treatment and study plan

Primary outcomes

  1. Patient preferences of treatment administration setting (homecare or hospital)

    Time frame: Baseline

    Survey responses of patient experience of injections at home and compared to responses of patient experience of injections when given in hospital

Secondary outcomes

  1. Demographic characteristics of enrolled patients with GEP-NETs

    Time frame: Baseline

    Age (years); Gender (male, female); Current employment status: full time, part time, unemployed, retired, student, homemaker, unpaid carer)

  2. Clinical characteristics of enrolled patients with GEP-NETs

    Time frame: Baseline

    Disease duration; Duration of homecare administration of lanreotide; Duration of hospital administration of lanreotide

  3. Patient-reported impact on healthcare resource use

    Time frame: Baseline

    Assessed using bespoke questionnaire a patient-reported opinion on how homecare administration compares to hospital administration (i.e. much worse / somewhat worse / about the same / somewhat better / much better) for the number of administration setting related aspects described in the protocol, as well as choosing the most applicable answer(s) where applicable.

  4. Patient-reported impact on wider societal costs

    Time frame: Baseline

    Assessed using bespoke questionnaire a patient-reported opinion on how homecare administration compares to hospital administration (i.e. much worse / somewhat worse / about the same / somewhat better / much better) for the number of administration setting related aspects described in the protocol, as well as choosing the most applicable answer(s) where applicable.

  5. Patient-reported work productivity

    Time frame: Baseline

    Assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) and bespoke questionaire

  6. Description of patient-reported HRQoL

    Time frame: Baseline

    Assessed using bespoke questionnaire a patient-reported opinion on how homecare administration compares to hospital administration (i.e. much worse / somewhat worse / about the same / somewhat better / much better) for the number of administration setting related aspects described in the protocol, as well as choosing the most applicable answer(s) where applicable.)

  7. Description of patient experience of taking lanreotide in the hospital and homecare settings and reported benefits/limitations of each setting;

    Time frame: 1 month

    Assessed using qualitative interviews which will be conducted over the telephone by an experienced qualitative interviewer. During the interview semi-structured interview guide will be used, based on guidance and feedback from a clinical expert (specialist nurse) and patient expert(s). The interviews will be primarily guided by the questions in the discussion guide; however, participants will be free to direct the conversation to topics they feel are relevant to their experience.

  8. Description of the impact of the homecare and hospital settings on HRQoL, work productivity, emotional and physical health

    Time frame: 1 month

    Assessed using qualitative interviews which will be conducted over the telephone by an experienced qualitative interviewer. During the interview semi-structured interview guide will be used, based on guidance and feedback from a clinical expert (specialist nurse) and patient expert(s). The interviews will be primarily guided by the questions in the discussion guide; however, participants will be free to direct the conversation to topics they feel are relevant to their experience.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Cross-Sectional Patient-Reported Study To Assess The Patient Preference Of Treatment Administration Setting, Impact On Health-Related Quality Of Life, Work Productivity, Wider Societal Costs And Healthcare Utilisation For Patients With Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Prescribed Somatuline® Autogel® In A Homecare Setting and Hospital Setting.

Acronym: PREF-NET

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2020
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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