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

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ClinicalTrials.gov Identifier: NCT04649580
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date September 23, 2020
First Posted Date December 2, 2020
Last Update Posted Date October 15, 2021
Actual Study Start Date April 27, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 25, 2020)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 24, 2021)
  • 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)
  • 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
  • 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.
  • 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.
  • Patient-reported work productivity [ Time Frame: Baseline ]
    Assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) and bespoke questionaire
  • 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.)
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: November 25, 2020)
  • 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)
  • 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
  • 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.
  • 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.
  • Patient-reported work productivity [ Time Frame: Baseline ]
    Assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) and bespoke questionaire
  • 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.)
  • 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 (study CI or 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.
  • 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 (study CI or 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title United Kingdom (UK) Patient Preference Study of Somatuline Autogel and Treatment Administration Setting
Official 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.
Brief Summary 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)
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population UK patients with NET receiving Somatuline Autogel injections at home
Condition Neuroendocrine Tumours (NET)
Intervention Not Provided
Study Groups/Cohorts
  • Online Survey
  • One-to-one interviews
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 25, 2020)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ipsen Recruitment Enquiries see email clinical.trials@ipsen.com
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04649580
Other Study ID Numbers A-GB-52030-394
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ipsen
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date October 2021